piracetam and Epilepsies, Partial

piracetam has been researched along with Epilepsies, Partial in 174 studies

Piracetam: A compound suggested to be both a nootropic and a neuroprotective agent.

Epilepsies, Partial: Conditions characterized by recurrent paroxysmal neuronal discharges which arise from a focal region of the brain. Partial seizures are divided into simple and complex, depending on whether consciousness is unaltered (simple partial seizure) or disturbed (complex partial seizure). Both types may feature a wide variety of motor, sensory, and autonomic symptoms. Partial seizures may be classified by associated clinical features or anatomic location of the seizure focus. A secondary generalized seizure refers to a partial seizure that spreads to involve the brain diffusely. (From Adams et al., Principles of Neurology, 6th ed, pp317)

Research

Studies (174)

Authors

Clinical Trials (29)

Trial Overview

Trial Outcomes

Percentage of Subjects Who Achieved Seizure Freedom During the 48 Weeks Treatment Period

48-week Seizure Freedom (rate) defined as the number and percentage of subjects who achieved seizure freedom during the Treatment Period (NCT01498822)
Timeframe: From Week 2 to Week 50 (During Treatment Period )

Percentage of Subjects Who Achieved Seizure Freedom for 24 Consecutive Weeks During the 48 Weeks Treatment Period at Any Time

24-week Seizure Freedom (rate) defined as the number and percentage of subjects who achieved seizure freedom for 24 consecutive weeks during the Treatment Period at any time (NCT01498822)
Timeframe: From Week 2 to Week 50 (During Treatment Period )

Percentage of Subjects With a Treatment Failure

Treatment failure is defined as (1) Dropout due to related intolerable adverse event, lack of efficacy or need for addition of another Antiepileptic Drug (AED), or (2) need of a 1-step down-Titration, within 50 weeks from the first dose of study medication. (NCT01498822)
Timeframe: Week 0 (First Dose) to Week 50

Time to the First Seizure Defined as the Time From the First Dose of Medication to the Occurrence of the First Seizure During the 48 Weeks Treatment Period

(NCT01498822)
Timeframe: From Week 2 to Week 50 (During Treatment Period )

Percent Change From Baseline in 28 Day Seizure Frequency at Week 16

The seizures were recorded by the participants, by a family member, by a caregiver, or by a legal guardian and documented in a daily seizure diary. Participant's 28-day seizure frequency of all partial seizure was assessed during double blind (TP + MP) phase compared with baseline. (NCT00537238)
Timeframe: Baseline, Week 16

Proportion of Participants With Response to Treatment

Participants who had at least 50% reduction in 28-day seizure rate from baseline to the end of the maintenance phase were considered as responders. The 28-day seizure rate was calculated as number of partial seizures in the period divided by difference of number of days in the period and number of missing diary day entries in the period, multiplied by 28. (NCT00537238)
Timeframe: Baseline up to Week 16

Change From Baseline in Brief Psychiatric Rating Scale - Anchored (BPRS-A) Total and Core Score at Week 7, 10, 13, 16 and Follow-up

BPRS-A:18-item clinician rated scale assesses somatic concern,anxiety, emotional withdrawal,conceptual disorganization,hallucinatory behavior(HB), guilt feelings,suspiciousness,disorientation,tension,mannerisms and posturing,grandiosity,depressive mood,hostility,motor retardation,uncooperativeness,unusual thought content,blunted affect,excitement. Items rated on 7-point scale 1 (not reported) to 7 (very severe). Total score=sum of items(range 18-126), core score=sum of conceptual disorganization, suspiciousness, HB, unusual thought content(range 4-28). Higher total/core score=more impairment. (NCT00537238)
Timeframe: Baseline, Week 7, 10, 13, 16 and Follow-up (Day 7 of taper phase)

Change From Baseline in the Proportion of 28-day Secondarily Generalized Tonic-clonic (SGTC) Seizure Rate to 28-day All Partial Seizure Rate at Week 16

Change was calculated as (proportion of SGTC seizure rate divided by all partial seizure rates during double blind phase) minus (proportion of SGTC seizure rate divided by all partial seizure rates at baseline). Negative values indicated reductions in seizures. (NCT00537238)
Timeframe: Baseline, Week 16

Hospital Anxiety and Depression Scale (HADS) Score

HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms. (NCT00537238)
Timeframe: Baseline, Week 16

Medical Outcomes Study Sleep Scale (MOS-SS) Score

Participant-rated 12-item questionnaire to assess constructs of sleep over past week; 7 subscales:sleep disturbance,snoring,awakened short of breath,sleep adequacy,somnolence (range:0-100);sleep quantity (range:0-24),optimal sleep(yes/no), and 9 item index measures of sleep disturbance provide composite scores:sleep problem summary,overall sleep problem. Except adequacy,optimal sleep and quantity, higher scores=more impairment. Scores transformed (actual raw score[RS] minus lowest possible score divided by possible RS range*100);total score range:0-100;higher score=more intensity of attribute. (NCT00537238)
Timeframe: Baseline, Week 16

Percentage of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) Score

MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Percentage of participants with optimal sleep are reported. (NCT00537238)
Timeframe: Baseline, Week 16

Percentage of Participants Without Seizures

Seizure free for 28 days was defined as participants who have not experienced any seizure (simple partial, complex partial and SGTC) for at least 28 consecutive days from their last seizure until the end of the maintenance phase. Same participant could be seizure free for a specific type of seizure but not necessarily for the other types of seizure. (NCT00537238)
Timeframe: Baseline up to Week 16

Change From Baseline at Week 19 in the Continuity of Attention T-score in the Randomization Phase (Core Study)

The Continuity of Attention domain (one of the 5 CDR System cognitive domains) was a measure of sustained attention, comprised of the accuracy scores from 2 of the CDR System attention tasks: choice reaction time and digit vigilance. Z-scores were calculated for this domain using normative data from the CDR System database for the age range of the study population. Specifically, Z-scores were calculated by subtracting each participant's domain score from the normative population mean of that domain and dividing the result by the SD of the normative population mean. Z-scores were converted into T-scores by multiplying by 50 and adding 50. Greater T-scores reflected superior cognitive function and a negative change from baseline reflects impairment compared to baseline. T-scores ranged from 0 to 100, with a mean of 50 and an SD of 10. (NCT01161524)
Timeframe: Baseline and Week 19

Change From Baseline at Week 19 in the Power of Attention T-score in the Randomization Phase (Core Study)

The Power of Attention domain (one of the 5 CDR System cognitive domains) was a measure of focused attention and information processing, comprised of the 3 CDR System attention tasks: the simple reaction time, choice reaction time and digit vigilance tasks. Z-scores were calculated for each domain by subtracting each participant's domain score from the normative population mean of that domain and dividing the result by the standard deviation (SD) of the normative population mean. Z-scores were converted into T-scores by multiplying by 50 and adding 50. Power of Attention were also multiplied by -1, so that for all domains, greater T-scores reflected superior cognitive function. T-scores ranged from 0 to 100, with a mean of 50 and an SD of 10. The CDR System Global Cognition score was created by adding the T-scores for the five domains. A decrease in the score of Power of Attention indicated improvement in cognitive function and a negative change reflects impairment from baseline. (NCT01161524)
Timeframe: Baseline and Week 19

Change From Baseline at Week 19 in the Quality of Episodic Secondary Memory T-score in the Randomization Phase (Core Study)

The Quality of Episodic Secondary Memory domain was a measure of the capability of individuals to encode, store, and subsequently retrieve verbal and nonverbal information in episodic (or declarative) memory; what was meant by memory in everyday terminology. This measure was derived by summing the scores from the 4 tasks: immediate and delayed word recall, word recognition, and picture recognition. Z-scores were calculated by subtracting each participant's domain score from the normative population mean of that domain and dividing the result by the SD of the normative population mean. Z-scores were converted into T-scores by multiplying by 50 and adding 50. Greater T-scores reflected superior cognitive function. T-scores ranged from 0 to 100, with a mean of 50 and an SD of 10. A high score reflects a good ability to store, hold and retrieve information of an episodic nature (i.e. an event or a name) and a negative change from baseline reflects impairment compared to baseline. (NCT01161524)
Timeframe: Baseline and Week 19

Change From Baseline at Week 19 in the Quality of Working Memory (Short Term) T-score in the Randomization Phase (Core Study)

The Quality of Working Memory domain (one of the 5 CDR System cognitive domains) was a measure of reflecting how well individuals can hold numeric and spatial information 'on line' in working memory. Z-scores were calculated by subtracting each participant's domain score from the normative population mean of that domain and dividing the result by the SD of the normative population mean. Z-scores were converted into T-scores by multiplying by 50 and adding 50. Greater T-scores reflected superior cognitive function. T-scores ranged from 0 to 100, with a mean of 50 and an SD of 10. A higher score reflects a good working memory and a negative change from baseline reflects impairment compared to the baseline assessment. (NCT01161524)
Timeframe: Baseline and Week 19

Change From Baseline at Week 19 in the Speed of Memory T-score in the Randomization Phase (Core Study)

The Speed of Memory domain (one of the 5 CDR System cognitive domains) was a measure, which reflects the time taken to accurately retrieve information from working and episodic memory. Z-scores were calculated for this domain using normative data from the CDR System database for the age range of the study population. Specifically, Z-scores were calculated by subtracting each participant's domain score from the normative population mean of that domain and dividing the result by the SD of the normative population mean. Z-scores were converted into T-scores by multiplying by 50 and adding 50. Speed of Memory were also multiplied by -1, so that for all domains, greater T-scores reflected superior cognitive function and a negative change from baseline reflects impairment compared to the baseline assessment. T-scores ranged from 0 to 100, with a mean of 50 and an SD of 10. (NCT01161524)
Timeframe: Baseline and Week 19

Change From Baseline to Week 19 in Cognition Drug Research (CDR) System Global Cognition Score (Core Study)

The CDR System Global Cognitive score was derived from the average of 5 CDR System cognitive domain scores (Power of Attention, Continuity of Attention, Quality of Episodic Memory, Quality of Working Memory, and Speed of Memory). The domain scores were normalized to mean of 50 and standard deviation of 10 before taking the average. The scale ranged from 0 - 100. An increase in the Global Cognitive Score indicates improvement, while a decrease indicates worsening in cognitive function. (NCT01161524)
Timeframe: Baseline (Visit 2/Week 0 Evaluation) and Week 19 LOCF (last observation carried forward)

Percent Change From Baseline in Seizure Frequency Per 28 Days During the Treatment Duration of the Randomization Phase (Core Study)

Seizure frequency was based on overall number of seizures obtained by summing the 4 seizure types (all partial seizure types, that is, simple partial without motor signs, simple partial with motor signs, complex partial, and complex partial with secondary generalization) collected via the patient diary over a particular time interval and re-scaled to 28 days window. (NCT01161524)
Timeframe: Baseline and Week 19 LOCF

Percentage of Participants Who Experienced 50% or More Decrease in Seizure Frequency (Core Study)

A responder was a participant who experienced a 50% or greater reduction in seizure frequency compared to the baseline of the Randomization Phase. (NCT01161524)
Timeframe: From Baseline up to Week 19 LOCF

Change From Baseline to End of Treatment (EOT) for the Tanner Stage

The effect of perampanel on growth and development in adolescents (male and female), including sexual development was measured using Tanner scale. The scale defined physical measurements of development based on external primary and secondary sex characteristics, such as the size of the breasts, genitals, testicular volume and development of pubic hair. Tanner scale consisted of 5 scales from I to V (1: pre-pubertal to 5: adult). Data is reported as the change from Baseline to End of Treatment for the Tanner Stage. (NCT01161524)
Timeframe: From Baseline up to Week 52 or EOT (defined as the last nonmissing value after date of first dose up to 14 days after date of last dose)

Change From Baseline to End of Treatment in Controlled Oral Word Association Test Scores (COWAT) (Extension Phase)

The COWAT test measured the executive function of the frontal lobe and consisted of examinations of category/meaning fluency and letter/phoneme fluency. It consisted of 2 parts which included the Letter Fluency task and the Category Fluency task. For the Letter Fluency task, the participant was given one minute to list as many words as they could which began with a given letter from the following set of 3 letters: F, A, and L. The number of correct words from the 3 sets comprised the Letter Fluency score. For the Category Fluency task, the participant was given one minute to list as many words as they could which belonged to a given category. The number of correct words comprised the Category Fluency score. Total score was calculated as sum of acceptable words generated. The scale ranged from 0-90, with higher scores indicating improvement in language. (NCT01161524)
Timeframe: From Baseline up to Week 52 or up to EOT (defined as the last nonmissing value after date of first dose up to 14 days after date of last dose)

Change From Baseline to End of Treatment in Time to Complete Lafayette Grooved Pegboard Test (LGPT) (Extension Phase)

The LGPT test measured visuomotor skills. This test was a manipulative dexterity test that consisted of a metal matrix of 25 holes with randomly positioned slots. The participant was required to insert 25 grooved pegs into the holes. The task was completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. The task was timed and the scores were the time taken for the participant to complete all 25 pegs for each hand. If the test cannot be completed within 300 seconds, 300 seconds were recorded for the time. An increase in score (longer time) indicated worsening of visuomotor skills. The time to complete test is presented as mean seconds +/- SD. (NCT01161524)
Timeframe: From Baseline up to Week 52 or up to EOT (defined as the last nonmissing value after date of first dose up to 14 days after date of last dose)

Mean Change From Baseline by Visits in CDR System Domain T-Scores (Extension Phase)

The Cognitive measure scores are presented as T-Scores. T-Scores were normalized standard scores with mean of 50 and SD of 10 with an absolute range of 0-100. The T-Scores are based on the norms from healthy age-matched controls from the CDR System database. Cohen's d-effect sizes were used to estimate the clinical relevance of a change in a parameter. A change in a score of 0.2 SD was defined by Cohen as a small effect size, 0.5 SD a medium effect size and 0.8 SD was considered a large effect size. An increase in the T-scores indicates improvement while a decrease in T-scores indicates worsening. Wk = Week and EOT=End of Treatment. The perampanel exposure duration starts from the first perampanel dose (in the Core Study for subjects previously randomized to perampanel or Extension Phase for subjects previously randomized to placebo) to the last perampanel dose in the Extension Phase. (NCT01161524)
Timeframe: Baseline, Week 9, Week 19, Week 30, Week 39, Week 52, and EOT (defined as the last nonmissing value after date of first dose up to 14 days after date of last dose)

Mean Change From Baseline in Bone Age Minus Age (Months) From Hand X-ray (Extension Phase)

"Bone age was measured using hand X-ray. The mean change from Baseline in bone age (months) minus age (months) from the hand x-ray was assessed. + means bone age is older than age and - means bone age is younger than age." (NCT01161524)
Timeframe: From Baseline up to Week 52 or up to EOT (defined as the last nonmissing value after date of first dose up to 14 days after date of last dose)

Mean Change From Baseline in CDR System Domain T-Score Over Time: Continuity of Attention (Extension Phase)

The Cognitive measure scores are presented as T-Scores at specific intervals (Week 9 for subjects with exposure of more than 9 weeks, Week 19 for subjects with exposure of more than 19 weeks, Week 30 for subjects with exposure of more than 26 weeks, Week 39 for subjects with exposure of more than 39 weeks, and Week 52 for subjects with exposure of more than 52 weeks). T-Scores were normalized standard scores with mean of 50 and SD of 10 with an absolute range of 0-100. The T-Scores are based on the norms from healthy age-matched controls from the CDR System database. Cohen's d-effect sizes were used to estimate the clinical relevance of a change in a parameter. A change in a score of 0.2 SD was defined by Cohen as a small effect size, 0.5 SD a medium effect size and 0.8 SD was considered a large effect size. An increase in the T-scores indicates improvement while a decrease in T-scores indicates worsening. (NCT01161524)
Timeframe: Baseline, Week 9, Week 19, Week, 30, Week 39, and Week 52

Mean Change From Baseline in CDR System Domain T-Score Over Time: Power of Attention (Extension Phase)

The Cognitive measure scores are presented as T-Scores at specific intervals (Week 9 for subjects with exposure of more than 9 weeks, Week 19 for subjects with exposure of more than 19 weeks, Week 30 for subjects with exposure of more than 26 weeks, Week 39 for subjects with exposure of more than 39 weeks, and Week 52 for subjects with exposure of more than 52 weeks). T-Scores were normalized standard scores with mean of 50 and SD of 10 with an absolute range of 0-100. The T-Scores are based on the norms from healthy age-matched controls from the CDR System database. Cohen's d-effect sizes were used to estimate the clinical relevance of a change in a parameter. A change in a score of 0.2 SD was defined by Cohen as a small effect size, 0.5 SD a medium effect size and 0.8 SD was considered a large effect size. An increase in the T-scores indicates improvement while a decrease in T-scores indicates worsening. (NCT01161524)
Timeframe: Baseline, Week 9, Week 19, Week 30, Week 39, and Week 52

Mean Change From Baseline in CDR System Domain T-Score Over Time: Quality of Episodic Secondary Memory (Extension Phase)

The Cognitive measure scores are presented as T-Scores at specific intervals (Week 9 for subjects with exposure of more than 9 weeks, Week 19 for subjects with exposure of more than 19 weeks, Week 30 for subjects with exposure of more than 26 weeks, Week 39 for subjects with exposure of more than 39 weeks, and Week 52 for subjects with exposure of more than 52 weeks). T-Scores were normalized standard scores with mean of 50 and SD of 10 with an absolute range of 0-100. The T-Scores are based on the norms from healthy age-matched controls from the CDR System database. Cohen's d-effect sizes were used to estimate the clinical relevance of a change in a parameter. A change in a score of 0.2 SD was defined by Cohen as a small effect size, 0.5 SD a medium effect size and 0.8 SD was considered a large effect size. An increase in the T-scores indicates improvement while a decrease in T-scores indicates worsening. (NCT01161524)
Timeframe: Baseline, Week 9, Week 19, Week 30, Week 39, and Week 52

Mean Change From Baseline in CDR System Domain T-Score Over Time: Quality of Working Memory (Short Term) (Extension Phase)

The cognitive measure scores are presented as T-Scores at specific intervals (Week 9 for participants with exposure of more than 9 weeks, Week 19 for participants with exposure of more than 19 weeks, Week 30 for participants with exposure of more than 26 weeks, Week 39 for participants with exposure of more than 39 weeks, and Week 52 for participants with exposure of more than 52 weeks). T-Scores were normalized standard scores with mean of 50 and SD of 10 with an absolute range of 0-100. The T-Scores are based on the norms from healthy age-matched controls from the CDR System database. Cohen's d-effect sizes were used to estimate the clinical relevance of a change in a parameter. A change in a score of 0.2 SD was defined by Cohen as a small effect size, 0.5 SD a medium effect size and 0.8 SD was considered a large effect size. An increase in the T-scores indicates improvement while a decrease in T-scores indicates worsening. (NCT01161524)
Timeframe: Baseline, Week 9, Week 19, Week, 30, Week 39, and Week 52

Mean Change From Baseline in CDR System Domain T-Score Over Time: Speed of Memory (Extension Phase)

The Cognitive measure scores are presented as T-Scores at specific intervals (Week 9 for subjects with exposure of more than 9 weeks, Week 19 for subjects with exposure of more than 19 weeks, Week 30 for subjects with exposure of more than 26 weeks, Week 39 for subjects with exposure of more than 39 weeks, and Week 52 for subjects with exposure of more than 52 weeks). T-Scores were normalized standard scores with mean of 50 and SD of 10 with an absolute range of 0-100. The T-Scores are based on the norms from healthy age-matched controls from the CDR System database. Cohen's d-effect sizes were used to estimate the clinical relevance of a change in a parameter. A change in a score of 0.2 SD was defined by Cohen as a small effect size, 0.5 SD a medium effect size and 0.8 SD was considered a large effect size. An increase in the T-scores indicates improvement while a decrease in T-scores indicates worsening. (NCT01161524)
Timeframe: Baseline, Week 9, Week 19, Week, 30, Week 39, and Week 52

Mean Change From Baseline in CDR System Global Cognition Score Over Time (Extension Phase)

The CDR System Global Cognitive was derived from the average of 5 CDR System cognitive domain scores (Power of Attention, Continuity of Attention, Quality of Episodic Memory, Quality of Working Memory, and Speed of Memory). Domain scores were normalized to mean of 50 and SD of 10 before taking the average. The scale ranged from 0 to 100. An increase in the Global Cognitive Score indicates improvement, while a decrease indicates worsening in cognitive function. The data is presented as CDR System Global Cognitive scores at specific intervals (Week 9 for subjects with exposure of more than 9 weeks, Week 19 for subjects with exposure of more than 19 weeks, Week 30 for subjects with exposure of more than 26 weeks, Week 39 for subjects with exposure of more than 39 weeks, and Week 52 for subjects with exposure of more than 52 weeks). (NCT01161524)
Timeframe: Baseline, Week 9, Week 19, Week, 30, Week 39, and Week 52

Mean Change From Baseline to End of Treatment in Cognition Drug Research (CDR) System Global Cognition Score (Extension Phase)

The CDR System Global Cognitive was derived from the average of 5 CDR System cognitive domain scores (Power of Attention, Continuity of Attention, Quality of Episodic Memory, Quality of Working Memory, and Speed of Memory). Domain scores were normalized to mean of 50 and standard deviation of 10 before taking the average. The scale ranged from 0 to 100. An increase in the Global Cognitive Score indicates improvement, while a decrease indicates worsening in cognitive function. The perampanel exposure duration starts from the first perampanel dose (in the Core Study for subjects previously randomized to perampanel or Extension Phase for subjects previously randomized to placebo) to the last perampanel dose in the Extension Phase. (NCT01161524)
Timeframe: Baseline, Week 9, Week 19, Week, 30, Week 39, Week 52, and End of Treatment (defined as the last nonmissing value after date of first perampanel dose up to 14 days after date of last dose)

Number of Participants Who Achieved Seizure-Free Status During the Maintenance Period and the Last 28 Days of the Maintenance Period During the Randomization Phase (Core Study)

Number of Participants who were seizure free, were assessed. (NCT01161524)
Timeframe: 13 Week Maintenance Period

Percent Change From Baseline in Seizure Frequency Per 28 Days Over the Perampanel Duration Exposure (Extension Phase)

The median percent change in total partial onset seizure frequency per 28 days during the Extension Phase relative to the Pre-perampanel Baseline from Week 1 of perampanel treatment through successive 13-week intervals (Weeks 1 to 13 for subjects with any data, Weeks 1 to 26 for subjects with exposure of more than 13 weeks, Weeks 1 to 39 for subjects with exposure of more than 26 weeks, and Week 1 to 52 for subjects with exposure of more than 52 weeks) are presented. The perampanel exposure duration starts from the first perampanel dose (in the Core Study for subjects previously randomized to perampanel or Extension Phase for subjects previously randomized to placebo) to the last perampanel dose in the Extension Phase. (NCT01161524)
Timeframe: Week 1-13, Week 14-26, Week 27-39, and Week 40-52

Percentage of Participants Who Experienced 50% or More Decrease in Seizure Frequency Over the Perampanel Duration Exposure (Extension Phase)

A responder was a participant who experienced a 50% or greater reduction in seizure frequency per 28 days from pre-perampanel. The percentage of responders from Week 1 of perampanel treatment through successive 13-week intervals (Weeks 1 to 13 for subjects with any data, Weeks 1 to 26 for subjects with exposure of more than 13 weeks, Weeks 1 to 39 for subjects with exposure of more than 26 weeks, and Week 1 to 52 for subjects with exposure of more than 52 weeks) are presented. The perampanel exposure duration starts from the first perampanel dose (in the Core Study for subjects previously randomized to perampanel or Extension Phase for subjects previously randomized to placebo) to the last perampanel dose in the Extension Phase. (NCT01161524)
Timeframe: Week 1-13, Week 14-26, Week 27-39, and Week 40-52

All Seizure Frequency (Type I+II+III) Per Week Over the 12-week Treatment Period

"There are three different types of seizures:~Type I: Partial seizures~Type II: Generalized seizures~Type III: Unclassified epileptic seizures.~All seizure frequency per week over Treatment Period (TP) was calculated as: (Total number of seizures over the TP)*7/(Total number of days with no missing seizure count in the TP)" (NCT00464269)
Timeframe: Baseline to 12-week Treatment Period

Change From Baseline to the 12-week Treatment Period in Cognitive Functioning Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score

The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline. (NCT00464269)
Timeframe: From Baseline to 12-week Treatment Period

Change From Baseline to the 12-week Treatment Period in Daily Activities / Social Functioning Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score

"The Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-items subscales - seizure worry (5 items), overall quality of life (2 items), emotional well-being (5 items), energy / fatigue (4 items), cognitive functioning (6 items), medication effects (3 items), and social function (5 items) - and a health status item.~The subscale scores, the total score and the health status item score range from 0 to 100 and higher scores indicating better function." (NCT00464269)
Timeframe: Baseline to 12-week Treatment Period

Change From Baseline to the 12-week Treatment Period in Emotional Well-Being Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score

The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline. (NCT00464269)
Timeframe: From Baseline to 12-week Treatment Period

Change From Baseline to the 12-week Treatment Period in Energy/Fatigue Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score

The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline. (NCT00464269)
Timeframe: From Baseline to 12-week Treatment Period

Change From Baseline to the 12-week Treatment Period in Health Status of Life Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score

The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline. (NCT00464269)
Timeframe: From Baseline to 12-week Treatment Period

Change From Baseline to the 12-week Treatment Period in Hospital Anxiety Score

The Hospital Anxiety and Depression Scale (HADS) was used to evaluate anxiety and depression. The HADS was developed as a self administered scale to assess the presence and severity of both anxiety and depression simultaneously. It consists of 14 items that are scored on a 4-point severity scale ranging from 0 to 3. A score per dimension was calculated with each score ranging from 0 to 21 and higher scores indicating higher depression / anxiety. A negative value in change from Baseline shows an improvement in HADS from Baseline. (NCT00464269)
Timeframe: Baseline to 12-week Treatment Period

Change From Baseline to the 12-week Treatment Period in Hospital Depression Score

The Hospital Anxiety and Depression Scale (HADS) was used to evaluate anxiety and depression. The HADS was developed as a self administered scale to assess the presence and severity of both anxiety and depression simultaneously. It consists of 14 items that are scored on a 4-point severity scale ranging from 0 to 3. A score per dimension was calculated with each score ranging from 0 to 21 and higher scores indicating higher depression / anxiety. A negative value in change from Baseline shows an improvement in HADS from Baseline. (NCT00464269)
Timeframe: Baseline to 12-week Treatment Period

Change From Baseline to the 12-week Treatment Period in Medication Effects Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score

The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline. (NCT00464269)
Timeframe: From Baseline to 12-week Treatment Period

Change From Baseline to the 12-week Treatment Period in Overall Quality of Life Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score

The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline. (NCT00464269)
Timeframe: From Baseline to 12-week Treatment Period

Change From Baseline to the 12-week Treatment Period in Seizure Worry Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score

"The Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-items subscales - seizure worry (5 items), overall quality of life (2 items), emotional well-being (5 items), energy / fatigue (4 items), cognitive functioning (6 items), medication effects (3 items), and social function (5 items) - and a health status item.~The subscale scores, the total score and the health status item score range from 0 to 100 and higher scores indicating better function." (NCT00464269)
Timeframe: Baseline to 12-week Treatment Period

Change From Baseline to the 12-week Treatment Period in Total Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score

"The Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-items subscales - seizure worry (5 items), overall quality of life (2 items), emotional well-being (5 items), energy / fatigue (4 items), cognitive functioning (6 items), medication effects (3 items), and social function (5 items) - and a health status item.~The subscale scores, the total score and the health status item score range from 0 to 100 and higher scores indicating better function." (NCT00464269)
Timeframe: Baseline to 12-week Treatment Period

Partial Onset Seizure (Type I) Frequency Per Week Over the 12-week Treatment Period

"Partial (Type I) seizures can be classified into one of the following three groups:~Simple partial seizures~Complex partial seizures~Partial seizures evolving to generalized tonic-clonic convulsions.~Partial Onset Seizure (POS) Frequency per week over the Treatment Period (TP) was calculated as:~(Total Type I seizures over the TP)*7/(Total number of days with no missing seizure count in the TP)" (NCT00464269)
Timeframe: Baseline to 12-week Treatment Period

Percent Change From Baseline to the 12-week Treatment Period in Partial Onset Seizure (Type I) Frequency Per Week

"Percent change from Baseline was calculated as percent reduction by:~(weekly seizure frequency Baseline - weekly seizure frequency Treatment)*100/(weekly seizure frequency Baseline).~The higher the values for percent change in Partial Onset Seizure (POS) frequency, the higher the improvement from Baseline." (NCT00464269)
Timeframe: Baseline to 12-week Treatment Period

Reduction of Type IC/Type I Seizure Frequency Ratio From Baseline to the 12- Week Treatment Period

The type IC/Type I seizure frequency ratio is represented by the percentage of subjects having a reduction in the ratio of Type IC seizure frequency over Type IA, IB, and IC seizure frequency from Baseline to Treatment Period. (NCT00464269)
Timeframe: Baseline to 12-week Treatment Period

Time to Fifth Type I Seizure During the 12-week Treatment Period

The time to fifth Partial Onset Seizure (POS) in the Treatment Period is defined as the time between beginning of the Treatment Period and the date of occurrence of fifth Type I seizure. Subjects withdrawing during the Treatment Period before having a fifth Type I seizure were considered as having a fifth Type I seizure on the last day of their Treatment Period. (NCT00464269)
Timeframe: Baseline to 12-week Treatment Period

Time to First Type I Seizure During the 12-week Treatment Period

The time to first Partial Onset Seizure (POS) in the Treatment Period is defined as the time between beginning of the Treatment Period and the date of occurrence of first Type I seizure. Subjects withdrawing during the Treatment Period before having a first Type I seizure were considered as having a first Type I seizure on the last day of their Treatment Period. (NCT00464269)
Timeframe: Baseline to 12-week Treatment Period

Time to Tenth Type I Seizure During the 12-week Treatment Period

The time to tenth Partial Onset Seizure (POS) in the Treatment Period is defined as the time between beginning of the Treatment Period and the date of occurrence of tenth Type I seizure. Subjects withdrawing during the Treatment Period before having a tenth Type I seizure were considered as having a tenth Type I seizure on the last day of their Treatment Period. (NCT00464269)
Timeframe: Baseline to 12-week Treatment Period

Categorized Percentage Change From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 12-week Treatment Period

"Subjects were classified in 1 of the following categories based on their percent reduction from Baseline to Treatment Period in Partial Onset Seizure (POS) frequency per week: <-25 %, -25 % to <25 %, 25 % to <50 %, 50 % to <75 %, 75 % to <100 %, and 100 %.~Subjects having zero for Baseline seizure frequency per week were classified in the <-25 % category." (NCT00464269)
Timeframe: Baseline to 12-week Treatment Period

Investigator's Global Evaluation Scale (I-GES) Evaluated at Last Visit or Early Discontinuation Visit

The Investigator's Global Evaluation Scale (I-GES) is a global assessment of the disease evolution which was performed using a seven-point scale (1 = Marked worsening to 7 = Marked improvement) with the start of the study medication as the reference time point. The investigator completed it by answering to the following: 'Assess the overall change in the severity of patient's illness, compared to start of study medication.' (NCT00464269)
Timeframe: Baseline to Last Visit or Early Discontinuation Visit in the 12-week Treatment Period

Patient's Global Evaluation Scale (P-GES) Evaluated at Last Visit or Early Discontinuation Visit

Patient's Global Evaluation Scale (P-GES) is a global assessment of the disease evolution which was performed using a seven-point scale (1= Marked worsening to 7 = Marked improvement) with the start of the study medication as the reference time point. The subject completed it by answering to the following: 'Overall, has there been a change in your seizures since the start of the study medication?' (NCT00464269)
Timeframe: Baseline to Last Visit or Early Discontinuation Visit in the 12-week Treatment Period

Responder Rate for Partial Onset Seizure (Type I) Frequency Per Week Over the 12-week Treatment Period

The responder rate was presented as the number of responders and non-responders. A subject is a responder, if the subject has at least 50 % reduction in partial onset seizure frequency per week from Baseline to Treatment Period. Subjects with zero seizure frequency per week at Baseline were considered as non-responders. (NCT00464269)
Timeframe: Baseline to 12-week Treatment Period

Seizure Freedom Rate (All Seizure Types) Over the 12-week Treatment Period

"Subjects were considered seizure free if their seizure counts for every day over the Treatment Period (TP) was zero and if they did not discontinue before the end of the TP. Seizure freedom rate was calculated as:~(total number of seizure - free subjects in treatment group during TP)/(total number of evaluable Intent-To-Treat (ITT) subjects in treatment group)" (NCT00464269)
Timeframe: Baseline to 12-week Treatment Period

All Seizure Frequency (Type I + II + III) During the 12-week Treatment Period

(NCT01261325)
Timeframe: 12 week Treatment Period

Percent Change in Partial Onset Seizure (Type I) Frequency From the Baseline to the Treatment Period

(NCT01261325)
Timeframe: Baseline to 12 week Treatment Period

Percent Reduction Over Placebo for Partial Onset Seizure (Type I) Frequency Over the Treatment Period Standardized to a 28-day Duration

Primary endpoint: United States of America (FDA) (NCT01261325)
Timeframe: 12 week Treatment Period

Time to the Fifth Type I Seizure During the Treatment Period

(NCT01261325)
Timeframe: 12 week Treatment Period

Time to the First Type I Seizure During the Treatment Period

(NCT01261325)
Timeframe: 12 week Treatment Period

Time to the Tenth Type I Seizure During the Treatment Period

(NCT01261325)
Timeframe: 12 week Treatment Period

50% Responder Rate for Partial Onset Seizure (Type I) Frequency Over the Treatment Period Standardized to a 28-day Duration

Primary Endpoint: European Regulatory Authorities A responder is a participant who experienced a 50% or greater reduction in partial onset seizure (Type I) frequency over the Treatment Period standardized to a 28-day duration. (NCT01261325)
Timeframe: Baseline to 12 week Treatment Period

Categorized Percent Reduction Form Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the Treatment Period

(NCT01261325)
Timeframe: Baseline to 12 week Treatment Period

Seizure Freedom Rate (All Seizure Types) During the 12-week Treatment Period

(NCT01261325)
Timeframe: 12 week Treatment Period

All Seizure Frequency (Type I+II+III) Per Week Over the 12-week Treatment Period

There are three types of Epilepsy: Partial Epilepsies (Type I), Generalized Epilepsies (Type II) and uncertain classification of Epilepsies (Type III). (NCT00490035)
Timeframe: From Baseline to 12-week Treatment Period

Change From Baseline to the 12-week Treatment Period in Cognitive Functioning Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score

The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline. (NCT00490035)
Timeframe: From Baseline to 12-week Treatment Period

Change From Baseline to the 12-week Treatment Period in Daily Activities/Social Functioning Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score

The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline. (NCT00490035)
Timeframe: From Baseline to 12-week Treatment Period

Change From Baseline to the 12-week Treatment Period in Emotional Well-Being Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score

The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline. (NCT00490035)
Timeframe: From Baseline to 12-week Treatment Period

Change From Baseline to the 12-week Treatment Period in Energy/Fatigue Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score

The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline. (NCT00490035)
Timeframe: From Baseline to 12-week Treatment Period

Change From Baseline to the 12-week Treatment Period in Health Status of Life Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score

The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline. (NCT00490035)
Timeframe: From Baseline to 12-week Treatment Period

Change From Baseline to the 12-week Treatment Period in Hospital Anxiety Score

The Hospital Anxiety and Depression Scale (HADS) was used to evaluate anxiety and depression simultaneously. The HADS was developed as a self-administered scale that has been designed to assess the presence and severity of both anxiety and depression. It consists of 14 items that are scored on a 4-point severity scale ranging from 0 to 3. A score per dimension was calculated with each score ranging from 0 to 21 and higher scores indicating higher depression / anxiety. Negative values in Change from Baseline indicate a decrease of HADS from Baseline to Treatment Period. (NCT00490035)
Timeframe: From Baseline to 12-week Treatment Period

Change From Baseline to the 12-week Treatment Period in Hospital Depression Score

The Hospital Anxiety and Depression Scale (HADS) was used to evaluate anxiety and depression simultaneously. The HADS was developed as a self-administered scale that has been designed to assess the presence and severity of both anxiety and depression. It consists of 14 items that are scored on a 4-point severity scale ranging from 0 to 3. A score per dimension was calculated with each score ranging from 0 to 21 and higher scores indicating higher depression / anxiety. Negative values in Change from Baseline indicate a decrease of HADS from Baseline to Treatment Period. (NCT00490035)
Timeframe: From Baseline to 12-week Treatment Period

Change From Baseline to the 12-week Treatment Period in Medication Effects Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score

The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline. (NCT00490035)
Timeframe: From Baseline to 12-week Treatment Period

Change From Baseline to the 12-week Treatment Period in Overall Quality of Life Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score

The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline. (NCT00490035)
Timeframe: From Baseline to 12-week Treatment Period

Change From Baseline to the 12-week Treatment Period in Seizure Worry Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score

The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline. (NCT00490035)
Timeframe: From Baseline to 12-week Treatment Period

Change From Baseline to the 12-week Treatment Period in Total Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score

The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline. (NCT00490035)
Timeframe: From Baseline to 12-week Treatment Period

Investigator's Global Evaluation Scale (I-GES) Evaluated at Last Visit or Early Discontinuation Visit

"The Investigator's Global Evaluation Scale (I-GES) is a global assessment of the disease evolution which was performed using a seven-point scale (1 = Marked worsening to 7 = Marked improvement), with the start of the study medication as reference time point. The Investigator was to complete it by answering the following question: Assess the Overall change in the severity of patient's illness, compared to start of study medication." (NCT00490035)
Timeframe: Last Visit or Early Discontinuation Visit in the 12-week Treatment Period

Partial Onset Seizure (Type I) Frequency Per Week Over the 12-week Treatment Period

Partial (Type I) Seizures can be classified into one of the following three groups: Simple Partial Seizures, Complex Partial Seizures, Partial Seizures evolving to Secondarily Generalized Seizures. (NCT00490035)
Timeframe: From Baseline to 12-week Treatment Period

Patient's Global Evaluation Scale (P-GES) Evaluated at Last Visit or Early Discontinuation Visit

"The Patient's Global Evaluation Scale (P-GES) is a global assessment of the disease evolution which was performed using a seven-point scale (1 = Marked worsening to 7 = Marked improvement) with the start of the study medication as the reference time point. The subject not mentally impaired had to complete it by answering the following question: Overall, has there been a change in your seizures since the start of the study medication?" (NCT00490035)
Timeframe: Last Visit or Early Discontinuation Visit in the 12-week Treatment Period

Percent Change From Baseline to the 12-week Treatment Period in Partial Onset Seizure (Type I) Frequency Per Week

The percent change from Baseline was computed as: Weekly Seizure Frequency (Treatment) - Weekly Seizure Frequency (Baseline) / Weekly Seizure Frequency (Baseline) * 100. Negative values indicate a reduction from Baseline with higher negative values showing higher reduction. (NCT00490035)
Timeframe: From Baseline to 12-week Treatment Period

Reduction of Type IC/Type I Seizure Frequency Ratio From Baseline to the 12- Week Treatment Period.

The type IC/Type I seizure frequency ratio is represented by the percentage of subjects having a reduction in the ratio of Type IC seizure frequency over Type IA, IB, and IC seizure frequency from Baseline to Treatment Period. (NCT00490035)
Timeframe: From Baseline to 12-week Treatment Period

Time to Fifth Type I Seizure During the 12-week Treatment Period

The time to Fifth Type I Seizure during the 12-week Treatment Period was measured in days. (NCT00490035)
Timeframe: From Baseline to 12-week Treatment Period

Time to First Type I Seizure During the 12-week Treatment Period

The time to first Type I Seizure during the 12-week Treatment Period was measured in days. (NCT00490035)
Timeframe: From Baseline to 12-week Treatment Period

Time to Tenth Type I Seizure During the 12-week Treatment Period

The time to tenth Type I Seizure during the 12-week Treatment Period was measured in days. (NCT00490035)
Timeframe: From Baseline to 12-week Treatment Period

Categorized Percentage Change From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 12-week Treatment Period

"The categories are:~<= 25 %~- 25 % to < 25 %~25 % to < 50 %~50 % to < 75 %~75 % to < 100 %~100 %" (NCT00490035)
Timeframe: From Baseline to 12-week Treatment Period

Responder Rate for Partial Onset Seizures (Type I) Frequency Per Week Over the 12-week Treatment Period

"Responders are those subjects with at least 50 % reduction from Baseline to Treatment Period in Partial Onset Seizure frequency per week.~The Responder Rate for Partial Onset Seizures (Type I) is the proportion of subjects who have a >= 50 % reduction in seizure frequency per week from Baseline." (NCT00490035)
Timeframe: From Baseline to 12-week Treatment Period

Seizure Freedom Rate (All Seizure Types) Over the 12-week Treatment Period

Subjects were considered seizure free if their seizure counts for every day over the entire Treatment Period was zero and if they completed the Treatment Period. (NCT00490035)
Timeframe: From Baseline to 12-week Treatment Period

Change in Serum Sex Hormone Binding Globulin (SHBG) From Baseline to Treatment Period End (Comprised of a 4-week Titration Period and an 8-week Maintenance Period)

Due to premature termination of enrollment prior to achieving the planned sample size (a total of 28 subjects), this primary safety variable was assessed for descriptive purposes only. A negative value indicates an improvement. (NCT01375374)
Timeframe: From Day 1 (Baseline) to Day 84 (Treatment Period End)

Change in Serum Thyroid Hormone Free Thyroxine Level From Baseline to Treatment Period End (Comprised of a 4-week Titration Period and an 8-week Maintenance Period)

The change in the serum thyroid hormone free thyroxine level from Baseline to the end of the Maintenance Period was summarized descriptively by visit. (NCT01375374)
Timeframe: From Day 1 (Baseline) to Day 84 (Treatment Period End)

Change in Sex Hormone Calculated Free Androgen Index Levels From Baseline to Treatment Period End (Comprised of a 4-week Titration Period and an 8-week Maintenance Period)

The change in sex hormone calculated free androgen index (100 x Testosterone/sex hormone binding globulin) levels from Baseline to the end of Maintenance Period was summarized descriptively by visit. A negative value indicates an improvement. (NCT01375374)
Timeframe: From Day 1 (Baseline) to Day 84 (Treatment Period End)

Change in Total Cholesterol Level From Baseline to Treatment Period End (Comprised of a 4-week Titration Period and an 8-week Maintenance Period)

The change in total cholesterol levels from Baseline to the end of the Maintenance Period was summarized descriptively by visit. A negative value indicates an improvement. (NCT01375374)
Timeframe: From Day 1 (Baseline) to Day 84 (Treatment Period End)

Retention at the End of the 21-week Treatment Period

Retention is a summary measure that integrates both the patient's and clinician's assessment of efficacy and tolerability in epilepsy clinical studies to provide a measure of effectiveness. (NCT01484977)
Timeframe: Duration of the Treatment Period (21 Weeks)

All (Type I+II+III) Seizures Frequency Per Week

Number of All type Seizures over the treatment period standardized to 1 week period (Type I -Partial Onset Seizures, Type II - Generalized Seizures, Type III - Unclassified Epileptic Seizures) (NCT00368069)
Timeframe: Treatment period (12 weeks)

Partial Onset Seizure (POS) Frequency Per Week - Intention-To-Treat (ITT) Population

Number of POS over the treatment period standardized to 1 week period. (NCT00368069)
Timeframe: Treatment period (12 weeks)

Partial Onset Seizure (POS) Frequency Per Week - Per Protocol (PP) Population

Number of POS over the treatment period standardized to 1 week period (NCT00368069)
Timeframe: Treatment Period (12 weeks)

50% Response in Weekly POS Frequency

A subject is considered as a 50% responder in POS if he/she has a >= 50% decrease from Baseline in the POS frequency/week over Treatment period. (NCT00368069)
Timeframe: Treatment period (12 weeks)

POS Seizure Frequency Per Week Over Baseline and Treatment Period

(NCT00368069)
Timeframe: Baseline Period (8 weeks) - Treatment Period (12 weeks)

Response in Weekly POS Frequency (Categorized Into 6 Categories According to Reduction) Over the Treatment Period of 12 Weeks

The response is classified according to the percent reduction from baseline in the POS frequency per week over the Treatment Period of 12 weeks duration. (NCT00368069)
Timeframe: over the treatment period (12 weeks)

Number of Patients With Adverse Events (AEs)

An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. (NCT00160654)
Timeframe: From Baseline until Safety visit (two weeks after last dose; up to Week 18)

Percentage Change From Historical Baseline in Partial (Type I) Seizure Frequency Per Week Over the Treatment Period

"Percentage change from baseline in partial (Type I) seizure frequency over the treatment period standardized to 1 week period.~Type I Partial (focal, local) seizure frequency per week will be derived from the seizure count information recorded on the daily record card (e.g. date, number, type of epileptic seizures) and is defined as the number of seizures standardized to a 1 week period.~A negative value in percent change from historical baseline indicates a decrease in partial (type I) seizure frequency from historical baseline." (NCT00160654)
Timeframe: Week 16, compared to Baseline

Percentage Change From Historical Baseline in Total (Type I+II+III) Seizure Frequency Per Week Over the Treatment Period

"Percentage change from baseline in total (type I+II+III) seizure frequency over the treatment period standardized to 1 week period.~Types I+II+III seizure frequency (Type I: Partial (focal, local), Type II: Generalized (convulsive or non-convulsive), Type III: Unclassified) per week will be derived from the seizure count information recorded on the daily record card (e.g. date, number, type of epileptic seizures) and is defined as the number of seizures standardized to a 1 week period.~A negative value in percent change from historical baseline indicates a decrease in total (type I+II+III) seizure frequency from historical baseline." (NCT00160654)
Timeframe: Week 16, compared to Baseline

Retention Rate at Week 16

Retention rate, defined as the number of subjects who were still on levetiracetam at Visit 5 (Week 16) or on the day before divided by the number of subjects in the ITT population. (NCT00160654)
Timeframe: Week 16

Percentage of Participants With 100% Response in Seizure Frequency Per Week at Week 16

"100% response in seizure frequency per Week is defined as 100% reduction in seizure frequency from Baseline.~Types I+II+III seizure frequency (Type I: Partial (focal, local), Type II: Generalized (convulsive or non-convulsive), Type III: Unclassified) per week will be derived from the seizure count information recorded on the daily record card (e.g. date, number, type of epileptic seizures) and is defined as the number of seizures standardized to a 1 week period." (NCT00160654)
Timeframe: Week 16, compared to Baseline

Percentage of Participants With 50% Response in Seizure Frequency Per Week at Week 16

"50% response in seizure frequency per Week is defined as >=50% reduction in seizure frequency from Baseline.~Types I+II+III seizure frequency (Type I: Partial (focal, local), Type II: Generalized (convulsive or non-convulsive), Type III: Unclassified) per week will be derived from the seizure count information recorded on the daily record card (e.g. date, number, type of epileptic seizures) and is defined as the number of seizures standardized to a 1 week period." (NCT00160654)
Timeframe: Week 16, compared to Baseline

Percentage of Patients With Categorized Change From Baseline in Severity of Illness

The overall change in the severity of the subject's illness, compared to the subject's condition prior to the levetiracetam intake, was assessed by the Investigator using Investigator's Global Evaluation Scale (IGS). Categories are as following: Marked improvement; Moderate improvement; Slight improvement; No change; Slight worsening; Moderate worsening; Marked worsening. (NCT00160654)
Timeframe: Baseline, Week 16

Partial Seizure (Type I) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More)

For subjects with greater than 24 weeks in the evaluation phase the denominator for each subject is their number of days in the evaluation phase. (NCT00152516)
Timeframe: Subjects with greater than 24 weeks of exposure

Partial Seizure (Type I) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More)

For subjects with up to 24 weeks in the evaluation phase the denominator for each subject is their number of days in the evaluation phase. (NCT00152516)
Timeframe: Subjects with up to 24 weeks of exposure

Total Seizure (Type I, II, III) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More)

For subjects with greater than 24 weeks in the evaluation phase the denominator for each subject is their number of days in the evaluation phase. (NCT00152516)
Timeframe: Subjects with greater than 24 weeks of exposure

Total Seizure (Type I, II, III) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More)

For subjects with up to 24 weeks in the evaluation phase the denominator for each subject is their number of days in the evaluation phase. (NCT00152516)
Timeframe: Subjects with up to 24 weeks of exposure

Bayley Scale of Infant Development (BSID) II Mental Development Index Scores Classification Shift From Baseline at Visit 5 (Week 24) (1 Month to < 4 Year Olds)

This score is obtained from a total raw score which is the sum of a battery of individual questions. It is adjusted for a child's age, has an expected mean of 100 and standard deviation of 15, and can be categorized as: (1) Accelerated Performance (>= 115), (2) Within Normal Limits (85-114), (3) Mildly Delayed Performance (70-84), and (4) Significantly Delayed Performance (<=69). Changes from baseline are then further categorized where 'Improved' is any positive category change, 'Stable' is no category change, and 'Worsened' is any negative category change, from baseline. (NCT00152516)
Timeframe: Visit 5 (Week 24)

Bayley Scale of Infant Development (BSID) II Mental Development Index Scores Classification Shift From Baseline at Visit 7 (Week 48) (1 Month to < 4 Year Olds)

This score is obtained from a total raw score which is the sum of a battery of individual questions. It is adjusted for a child's age, has an expected mean of 100 and standard deviation of 15, and can be categorized as: (1) Accelerated Performance (>= 115), (2) Within Normal Limits (85-114), (3) Mildly Delayed Performance (70-84), and (4) Significantly Delayed Performance (<=69). Changes from baseline are then further categorized where 'Improved' is any positive category change, 'Stable' is no category change, and 'Worsened' is any negative category change, from baseline. (NCT00152516)
Timeframe: Visit 7 (week 48)

Bayley Scale of Infant Development (BSID) II Psychomotor Development Index Scores Classification Shift From Baseline at Visit 5 (Week 24) (1 Month to < 4 Year Old)

This score is obtained from a total raw score which is the sum of a battery of individual questions. It is adjusted for a child's age, has an expected mean of 100 and standard deviation of 15, and can be categorized as: (1) Accelerated Performance (>= 115), (2) Within Normal Limits (85-114), (3) Mildly Delayed Performance (70-84), and (4) Significantly Delayed Performance (<=69). Changes from baseline are then further categorized where 'Improved' is any positive category change, 'Stable' is no category change, and 'Worsened' is any negative category change, from baseline. (NCT00152516)
Timeframe: Visit 5 (week 24)

Bayley Scale of Infant Development (BSID) II Psychomotor Development Index Scores Classification Shift From Baseline at Visit 7 (Week 48) (1 Month to < 4 Year Old)

This score is obtained from a total raw score which is the sum of a battery of individual questions. It is adjusted for a child's age, has an expected mean of 100 and standard deviation of 15, and can be categorized as: (1) Accelerated Performance (>= 115), (2) Within Normal Limits (85-114), (3) Mildly Delayed Performance (70-84), and (4) Significantly Delayed Performance (<=69). Changes from baseline are then further categorized where 'Improved' is any positive category change, 'Stable' is no category change, and 'Worsened' is any negative category change, from baseline. (NCT00152516)
Timeframe: Visit 7 (week 48)

Change (Reduction) From Baseline in Partial (Type I) Seizure Frequency Per Week Over Time During Treatment Period

Positive changes from Baseline indicate an improvement (i.e., a reduction) in seizure frequency per week. (NCT00152516)
Timeframe: Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)

Change (Reduction) From Baseline in Total (Type I, II, III) Seizure Frequency Per Week Over Time During Treatment Period

Positive changes from Baseline indicate an improvement (i.e., a reduction) in seizure frequency per week. (NCT00152516)
Timeframe: Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)

Investigator Global Evaluation Scale

There are 7 categories, 3 for improvement (Marked improvement, Moderate improvement, Slight improvement), 3 for worsening (Slight worsening, Moderate worsening, Marked worsening), and 1 for no change (No change). (NCT00152516)
Timeframe: End of Evaluation period (week 48 or at point of early discontinuation)

Leiter-R Associated Memory (AM) Memory Screen Composite Score Change From Baseline to Visit 5 (Week 24) and Visit 7 (Week 48) (4 to 16 Year Olds)

The Leiter-R AM battery has 10 subtests. The raw scores of the subtests are converted into scaled scores. Six composite scores are constructed from the 10 subtest scaled scores. The Memory Screen is one of them. It is composed of 2 subtests the Associated Pairs and Forward Memory. The sum of the Associated Pairs and Forward Memory subtest scaled scores are converted into a Memory composite score normally distributed with a mean and standard deviation of 100 (±15). Higher scores and positive changes from baseline are better. The range of the Memory Screen composite score is 44 to 155. (NCT00152516)
Timeframe: Baseline to Visit 5 (Week 24) and Visit 7 (Week 48)

Parent/Guardian Global Evaluation Scale

There are 7 categories, 3 for improvement (Marked improvement, Moderate improvement, Slight improvement), 3 for worsening (Slight worsening, Moderate worsening, Marked worsening), and 1 for no change (No change). (NCT00152516)
Timeframe: End of Evaluation period (week 48 or at point of early discontinuation)

Partial (Type I) Seizure Frequency Per Week Over Time During Treatment Period.

(NCT00152516)
Timeframe: Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)

Partial Seizure (Type I) Responder Rate (Percent) During the Up-titration/Conversion Phase and by Visit During the Maintenance Phase

"The responder rate is defined as the number of responders. A responder is a patient with a 50% or greater change (reduction) in partial seizure frequency per week.~Note: Rates were reported as percentages." (NCT00152516)
Timeframe: Up-titration (4 weeks); Maintenance Visits 3-4 (weeks 4-14, 6-15, or 8-16); Visits 4-5 (weeks 14-24, 15-24, or 16-24); Visits 5-6 (weeks 24-36); Visits 6-7 (weeks 36-48)

Percent of Subjects With Each Seizure Type During the Evaluation Period

"Type I Seizure is a partial onset Seizure (see International League Against Epilepsy definitions).~Type II Seizure is a Generalized Seizure (see International League Against Epilepsy definitions).~Type III Seizure is a Unknown Seizure Type (see International League Against Epilepsy definitions).~A subject could experience more than one seizure type." (NCT00152516)
Timeframe: Evaluation period (48 weeks)

Percentage Change (Reduction) of Partial (Type I) Seizure Frequency Per Week From Baseline Over Time During Treatment Period.

Positive changes from Baseline indicate an improvement (i.e., a reduction) in seizure frequency per week. (NCT00152516)
Timeframe: Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)

Percentage Change (Reduction) of Total (Type I, II, III) Seizure Frequency Per Week From Baseline Over Time During Treatment Period.

Positive changes from Baseline indicate an improvement (i.e., a reduction) in seizure frequency per week. (NCT00152516)
Timeframe: Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)

Subject (>=8 Years Old) Global Evaluation Scale

There are 7 categories, 3 for improvement (Marked improvement, Moderate improvement, Slight improvement), 3 for worsening (Slight worsening, Moderate worsening, Marked worsening), and 1 for no change (No change). (NCT00152516)
Timeframe: End of Evaluation period (week 48 or at point of early discontinuation)

Total (Type I, II, III) Seizure Frequency Per Week Over Time During Treatment Period.

(NCT00152516)
Timeframe: Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)

Total Seizure (Type I, II, III) Continuously Seizure Free During the Maintenance Period

"The measure description is the product limit adjusted percent of subjects seizure free starting from the beginning of the Maintenance Period.~The up-titration period is the up to 6 week period of increasing dose prior to the Maintenance Period. The Maintenance Period is the period of stable dosing, subsquent to the up-titration period, which could last from 42 to 48 weeks." (NCT00152516)
Timeframe: greater than or equal to 24 weeks, greater than or equal to 40 weeks

The Cumulative Exit Rate at 112 Days After the Beginning of the Previous Antiepileptic Drug (AED) Tapering Phase

Cumulative exit rate at day 112, based on the duration between start date of previous AED tapering to the earliest date exit criterion was met; calculated using Kaplan Meier Methods. Subjects prematurely discontinued for reasons unrelated to exit criteria were censored as of last dose of study drug. Subjects who completed without meeting exit criteria were censored at Day 112. Exit criteria include increase in seizure frequency, severity, duration, status epilepticus, or new generalized seizure. Upper 95% 2-sided confidence limit for exit rate is compared to the historical control rate: 0.678. (NCT00419094)
Timeframe: 112 days

The Cumulative Exit Rate at 112 Days for the Keppra XR 1000 mg Group After the Beginning of the Previous Antiepileptic Drug (AED) Tapering Phase

Keppra XR 1000 mg arm was not intended for inferential analysis (planned 3 to 1 randomization, Keppra XR 2000 mg: 1000 mg). The Exit Rate was based on the duration between the start date of previous AED tapering to the earliest date an exit crterion was met. Subjects who prematurely discontinued for reasons unrelated to exit criteria were censored as of the last dose of study medication. Subjects who completed the study without meeting an exit criterion were censored as of Day 112. (NCT00419094)
Timeframe: 112 days

The Cumulative Rate of Exit Events Due to Any Reasons at 112 Days After the Beginning of Previous Antiepileptic Drug (AED) Tapering Phase

The cumulative exit event rate at Day 112 was calculated using Kaplan Meier methods. The exit event rate estimate was based on the duration between the start date of previous AED tapering to the earliest date an exit event occured. Subjects who completed the study without having an exit event were censored as of Day 112. (NCT00419094)
Timeframe: 112 days

The Cumulative Rate of Exit Events, Which Include Discontinuation Due to Exit Criteria, Withdrawal Due to Adverse Events (AE) and Withdrawal Due to Lack of Efficacy, at 112 Days After the Beginning of Previous Antiepileptic Drug (AED) Tapering Phase

The cumulative exit event rate at Day 112 was calculated using Kaplan Meier methods. The exit event rate estimate was based on the duration between the start date of previous AED tapering to the earliest date an exit event occured. Subjects who prematurely discontinued for reasons unrelated to exit criteria, adverse event, or lack of efficacy were censored as of the last dose of study medication. Subjects who completed the study without having an exit event were censored as of Day 112. (NCT00419094)
Timeframe: 112 days

Mean Change in Focal Interictal Discharges (IEDs) Per Hour, Pre to Post Treatment

This descriptive analysis examined the change in interictal discharge rates pre to post-treatment with levetiracetam in subjects with epilepsy and with no treatment in healthy controls. (NCT00916149)
Timeframe: 1 and 11 weeks

Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Adverse Events Profile (AEP)

Change in Adverse Events Profile score (scores range from 19-76; higher scores indicate greater side effects) (NCT00916149)
Timeframe: 1 and 11 weeks

Performance on Neuropsychological Batteries and Computerized Cognitive Testing: BVMT-R Delayed Recall

Change in Brief Visuospatial Memory Test-Revised (BVMT-R) Delayed Recall score (the score ranges from 0-6, reflecting the number of shapes recalled after a 25 minute delay) (NCT00916149)
Timeframe: 1 and 11 weeks

Performance on Neuropsychological Batteries and Computerized Cognitive Testing: BVMT-R Learning

Change in Brief Visuospatial Memory Test-Revised (BVMT-R) Learning score (the score ranges from 0-6, reflecting the number of shapes recalled on the initial learning trial) (NCT00916149)
Timeframe: 1 and 11 weeks

Performance on Neuropsychological Batteries and Computerized Cognitive Testing: BVMT-R Total Learning

Change in Brief Visuospatial Memory Test-Revised (BVMT-R) Total Learning score (the score is summed across 3 learning trials, score range 0-18, reflecting the total number of shapes recalled) (NCT00916149)
Timeframe: 1 and 11 weeks

Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Choice Accuracy

Change in Choice Accuracy Score (indicate if red or blue stimulus; accuracy 0-100%) (NCT00916149)
Timeframe: 1 and 11 weeks

Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Choice Reaction Time

Change in Choice Reaction Time Score, with reaction time measured in seconds (indicate if red or blue stimulus; lower reaction time suggests better performance) (NCT00916149)
Timeframe: 1 and 11 weeks

Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CPT Accuracy

Change in Continuous Performance Test Score - Accuracy (CPT; score ranges from 0-100% correct) (NCT00916149)
Timeframe: 1 and 11 weeks

Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CPT Reaction Time (CPT RT)

Change in Continuous Performance Test Score - Reaction Time, measured in seconds (CPT RT; less time reflects better performance) (NCT00916149)
Timeframe: 1 and 11 weeks

Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CVLT Long Delay

Change in California Verbal Learning Test (CVLT) Long Delay Recall score (the score ranges from 0-16, reflecting the number of words recalled) (NCT00916149)
Timeframe: 1 and 11 weeks

Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CVLT Short Delay

Change in California Verbal Learning Test (CVLT) Short Delay Recall Score (the score ranges from 0-16, reflecting the number of words recalled) (NCT00916149)
Timeframe: 1 and 11 weeks

Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CVLT Total Learning

Change in California Verbal Learning Test (CVLT) Total Learning Score (the total learning score is summed across 5 learning trials, range 0-80). Higher scores indicate better memory. Scores on the CVLT reflect the number of words recalled. (NCT00916149)
Timeframe: 1 and 11 weeks

Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CVLT Trial 1 Learning Score

Change in California Verbal Learning Test (CVLT) Trial 1 learning score (range 0-16; higher score indicates better memory) (NCT00916149)
Timeframe: 1 and 11 weeks

Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Design Fluency

Change in Design Fluency score (Score range: lowest score = 0; there is no upper limit. A higher score reflects more designs generated, hence better performance.) (NCT00916149)
Timeframe: 1 and 11 weeks

Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Digit Span

Change in Digit Span score (score ranges from 0-30; higher scores indicate better performance). Scores indicate the number of digit sequences correctly recalled, forwards and backwards. (NCT00916149)
Timeframe: 1 and 11 weeks

Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Digit Symbol

Change in Digit Symbol Score (The score is the number of items completed. A higher score reflects better performance.) (NCT00916149)
Timeframe: 1 and 11 weeks

Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Facial Recognition Accuracy

Change in Facial Recognition Accuracy Score (accuracy ranges from 0-100%) (NCT00916149)
Timeframe: 1 and 11 weeks

Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Facial Recognition Reaction Time

Change in Facial Recognition Reaction Time Score (indicates processing speed, with reaction time measured in seconds) (NCT00916149)
Timeframe: 1 and 11 weeks

Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Grooved Pegboard

Change in Grooved Pegboard Score (The score is the time for completion. A lower score reflects better performance.) (NCT00916149)
Timeframe: 1 and 11 weeks

Performance on Neuropsychological Batteries and Computerized Cognitive Testing: LNS

Change in Letter-Number Sequencing score (LNS; score ranges from 0-21; higher scores indicate better performance). The score reflects the number of items that the subject can correctly recall and place in proper alphabetical and numerical sequence. (NCT00916149)
Timeframe: 1 and 11 weeks

Performance on Neuropsychological Batteries and Computerized Cognitive Testing: NDDIE

Change in Neurological Disorders Depression Inventory for Epilepsy (NDDIE) score (scores range from 0-24; higher scores indicate greater depressive symptoms) (NCT00916149)
Timeframe: 1 and 11 weeks

Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Non-verbal Working Memory Accuracy

Change in Non-verbal Working Memory Accuracy Score (accuracy ranges from 0-100%) (NCT00916149)
Timeframe: 1 and 11 weeks

Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Non-verbal Working Memory Reaction Time

Change in Non-verbal Working Memory Reaction Time Score (indicates processing speed, with reaction time measured in seconds) (NCT00916149)
Timeframe: 1 and 11 weeks

Performance on Neuropsychological Batteries and Computerized Cognitive Testing: QOLIE

Change in Quality of Life Inventory in Epilepsy-89 score (QOLIE; score ranges from 0-100; higher scores reflect better quality of life) (NCT00916149)
Timeframe: 1 and 11 weeks

Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Spatial Span

Change in Spatial Span score (score ranges from 0-32; higher scores indicate better performance). Scores indicate the number of spatial sequences correctly recalled, forwards and backwards. (NCT00916149)
Timeframe: 1 and 11 Weeks

Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Stroop

Change in Stroop score (The score is the time for completion in seconds; less time reflects better performance.) (NCT00916149)
Timeframe: 1 and 11 weeks

Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Trails Test

Change in Trails Test score (The score is the time for completion in seconds. A lower score reflects better performance.) (NCT00916149)
Timeframe: 1 and 11 weeks

Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Verbal Fluency

Change in Verbal Fluency score (Score range: lowest score = 0, with no upper limit, reflecting total number of words generated. Higher scores indicate better performance.) (NCT00916149)
Timeframe: 1 and 11 weeks

Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Verbal Recognition Accuracy

Change in Verbal Recognition Accuracy Score (accuracy ranges from 0-100%) (NCT00916149)
Timeframe: 1 and 11 weeks

Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Verbal Recognition Reaction Time

Change in Verbal Recognition Reaction Time Score (indicates processing speed, with reaction time measured in seconds) (NCT00916149)
Timeframe: 1 and 11 weeks

Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Verbal Working Memory Accuracy

Change in Verbal Working Memory Accuracy Score (range 0-100%) (NCT00916149)
Timeframe: 1 and 11 weeks

Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Verbal Working Memory Reaction Time

Change in Verbal Working Memory Reaction Time Score, with reaction time measured in seconds (indicates processing speed) (NCT00916149)
Timeframe: 1 and 11 weeks

Reviews

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Other Studies

82 other studies available for piracetam and Epilepsies, Partial