carbamazepine and Abdominal Epilepsy

carbamazepine has been researched along with Abdominal Epilepsy in 492 studies

Carbamazepine: A dibenzazepine that acts as a sodium channel blocker. It is used as an anticonvulsant for the treatment of grand mal and psychomotor or focal SEIZURES. It may also be used in the management of BIPOLAR DISORDER, and has analgesic properties.
carbamazepine : A dibenzoazepine that is 5H-dibenzo[b,f]azepine carrying a carbamoyl substituent at the azepine nitrogen, used as an anticonvulsant.

Research

Studies (492)

Authors

Clinical Trials (16)

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 )

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

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)

Analysis of Time to Drop Out Due to an Adverse Event (AE)

An AE is defined as any untoward medical occurrence in a subject and does not necessarily have a causal relationship with the medicinal product. Adverse events were identified by: any unfavorable or unintended sign, symptom or disease temporarily associated with the use of a medicinal product; any new disease or exacerbation of an existing disease; any deterioration in nonprotocol-required measurements of laboratory values or other clinical test; and recurrence of an intermittent medical condition not present at Baseline. (NCT00477295)
Timeframe: Week 1 through Week 109

Analysis of Time to Drop Out Due to Lack of Efficacy

Lack of efficacy was evaluated by the subject and on the basis of whether zonisamide and carbamazepine gave the subject at least a 26-week seizure free rate. The subject could withdraw at any time due to lack of efficacy. (NCT00477295)
Timeframe: Week 1 through Week 109

Change From Baseline in QOLIE-31-P Overall Score at Maintenance Period Visit 1

"The Quality of Life in Epilepsy - Problems(QOLIE-31-P) was completed by the patient and contained 30 items covering seven subscales(seizure worry, overall~Quality of Life (QOL),emotional well-being,energy-fatigue, cognition,medication effects and social function) and one item covering health status. It also included seven items addressing overall distress related to each subscale, an item addressing the relative importance of each subscale topic, and an item addressing perception of overall change in QOL at the end of the study. A high score reflects a good QOL. The following scale range is a sample of 1 of the 7 of the subscales:~10 (Best possible quality of life) - 0 (Worst possible quality of life);~Rand Corporation QOLIE-31 Scoring Manual was used. The QOLIE-31 overall score is calculated by summing the product of each scale score times its weight and summing overall all scales." (NCT00477295)
Timeframe: Baseline and Maintenance Period Visit 1 (Week 31 to Week 83)

Change From Baseline in Total ABNAS Score at Maintenance Period Visit 1

The Aldenkamp-Baker Neuropsychological Assessment Scale(ABNAS) is a subject based questionnaire to measure subjective perceived drug-related cognitive impairments. The ABNAS measured seven critical domains of cognition(tiredness/fatigue,hyperexcitability, slowing(mental and motor),memory impairment,attention disorders,impairment of motor coordination, and language disorders). The total score ranged from 0 to 72, with a higher score reflecting a high level of problems. (NCT00477295)
Timeframe: Baseline and Maintenance Period Visit 1 (Week 31 to Week 83)

Percentage of Participants Who Experienced Seizure Freedom for 12-months During the FDP and Maintenance Period

A subject achieved a 12-month seizure-free period if they were free of all seizures, regardless of seizure type, for 12 months while receiving the same dose. The occurrence of seizures was documented in the seizure diary, which was maintained by the subject and reviewed at each following visit. (NCT00477295)
Timeframe: Week 5 through Week 109

Percentage of Participants Who Experienced Seizure Freedom for 26-weeks During the Maintenance Phase

A subject achieved a 26-week seizure-free period if they were free of all seizures, regardless of seizure type, for 26 weeks while receiving the same dose. The occurrence of seizures was documented in the seizure diary, which was maintained by the subject and reviewed at each following visit. (NCT00477295)
Timeframe: Week 31 through Week 109

Time to 12-months Seizure Freedom

A subject achieved a 12-month seizure-free period if they were free of all seizures, regardless of seizure type, for 12-months while receiving the same dose. The occurrence of seizures was documented in the seizure diary, which was maintained by the subject and reviewed at each following visit. (NCT00477295)
Timeframe: Week 5 through Week 83

Time to 6-months Seizure Freedom

A subject achieved a 6-months seizure-free period if they were free of all seizures, regardless of seizure type, for 6-months while receiving the same dose. The occurrence of seizures was documented in the seizure diary, which was maintained by the subject and reviewed at each following visit. (NCT00477295)
Timeframe: Week 5 through Week 83

Change From Baseline in Bond and Lader VAS Mood Sub-Scores at Maintenance Period Visit 1

"The Bond-Lader Visual Analogue Scale (VAS) is made up of 16 pairs of alternative descriptors of mood and attention at either end of a 10 cm line.~Subjects were asked to rate their feelings at the time of assessment by indicating the point on the line which best represent their mood. Each item was scored by measuring the position relative to the left hand end of the line and levels of anxiety, sedation, and dysphoria were then calculated from the combined scores of selected items. The scores ranged from 0 to 100, with a high score reflecting a high level of anxiety, sedation or dysphoria." (NCT00477295)
Timeframe: Baseline and Maintenance Period Visit 1 (Week 31 to Week 83)

Change From Baseline in SF-36 Aggregate Mental and Physical Component Score at Maintenance Period Visit 1

The Short Form 36 Health and Well-Being Questionnaire (SF-36) is a 36-item generic health related QOL instrument covering the following domains: physical functioning, role-physical,bodily pain, general health, social functioning,role-emotional, mental health, and vitality. It yields a profile of eight scores, one for each domain, and physical and mental health summary measures. Each domain is described by a score ranging from 0 to 100, for a range of total possible scoes of 0-400 for physical and 0-400 for mental. An increase represents an improvement, whereas a decrease reflects a worsening. (NCT00477295)
Timeframe: Baseline and Maintenance Period Visit 1 (Week 31 to Week 83)

Percentage of Participants With EQ-5D Scores at Maintenance Period Visit 1

The European Quality of Life Group 5-Dimension Self-Report Questionnaire (EQ-5D) is a preference based generic health related quality of life (HRQoL) instrument which classifies health states across five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each domain has three levels, they are (1) no problems, (2) some problems, (3) extreme problems. The percentages shown are calculated from the number of subjects at that visit with non-missing data for that score. (NCT00477295)
Timeframe: Week 31 through Week 83

Change in Number of Absence Seizures From Week 8 (Baseline) to Week 12

The secondary outcome measure is the change in number of absence seizures from Week 8 (Baseline) to Week 12 (NCT01607073)
Timeframe: Week 8 to Week 12

Change in Number of General Tonic-clonic Seizures From Week 8 (Baseline) Visit to Week 12 Visit

The primary study endpoint is the change in number of seizures from baseline. Since we only had one participant finish the study, the endpoint was changed to Week 12 visit. Participants were on verapamil for 4 weeks at Week 12. (NCT01607073)
Timeframe: Week 8 (baseline) to Week 12

Change in Number of Myoclonic Seizures From Week 8 (Baseline) to Week 12

The secondary outcome is the change in number of myoclonic seizures between baseline Week 8 visit and Week 12 visit. (NCT01607073)
Timeframe: Week 8 (baseline) to Week 12

Change From Baseline in Adverse Event Profile (AEP) Score

Adverse Events Profile (AEP) is a 19-item scale used as a systematic measure of adverse effects from antiepileptic drugs (AEDs). Scores range from 19-76; higher scores indicate high prevelance and severity of adverse events. (NCT00522418)
Timeframe: Mean change from baseline AEP Score at 12 months

Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D) Score

The Center for Epidemiologic Studies Depression Scale (CES-D) includes 20 items comprising six scales reflecting major dimensions of depression: depressed mood, feelings of guilt and worthlessness, feelings of helplessness and hopelessness, psychomotor retardation, loss of appetite, and sleep disturbance. Possible range of scores is 0 to 60, higher scores indicate more depressive symptoms. (NCT00522418)
Timeframe: Mean change from baseline CES-D Score at 12 months

Change From Baseline in Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) Score

The Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) is a 6-item questionnaire validated to screen for depression in people with epilepsy. Scores range from 6 to 24, with higher scores indicating more depressive symptoms. (NCT00522418)
Timeframe: Mean change from baseline NDDI-E Score at 12 months

Changes in Anti-epileptic Drugs (AEDs)

Change from baseline in number of AED medications by visit (NCT00522418)
Timeframe: Change from baseline in number of AEDs at 12 months

Mean Change From Beginning of Intervention Clinical Global Impression-Improvement Scale (CGI-I) Score at 12 Months

The Clinical Global Impression scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention Scores range from 1-7: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. (NCT00522418)
Timeframe: Mean change from baseline CGI-I Score at 12 months

Mean Percent Change in Seizure Frequency

Percent change in total seizuires per week from baseline at 12 months (NCT00522418)
Timeframe: Mean percent change from baseline in seizure frequency at 12 months

Overall Quality of Life in Epilepsy-89 (QOLIE-89) Score in Patients With Baseline & at Least One Post-baseline QOLIE Assessment

QOLIE-89 contains 17 multi-item measures of overall quality of life, emotional well-being, role limitations due to emotional problems, social support, social isolation, energy/fatigue, worry about seizure, medication effects, health discouragement, work/driving/social function, attention/concentration, language, memory, physical function, pain, role limitations due to physical problems, and health perceptions. Range of values 0-100. Higher scores reflect better quality of life; lower ones, worse quality of life. (NCT00522418)
Timeframe: Mean change from baseline QOLIE-89 Overall Score at 12 months

Response Rate

Response Rate is defined as the percent of participants who are responders. A Responder is defined as participants with a reduction of at least 50% or 75% in seizure frequency from baseline to the seizure count evaluation period. (NCT00522418)
Timeframe: Number of Responders at 12 Months

Change From Baseline in QOLIE-89 Measures: Subgroup Analysis of Population With Baseline Adverse Event Profile Score < 40

QOLIE-89 contains 17 multi-item measures of overall quality of life. Range of values 0-100. Higher scores reflect better quality of life; lower ones, worse quality of life. Adverse Events Profile (AEP) is a 19-item scale used as a systematic measure of adverse effects from antiepileptic drugs (AEDs). Scores range from 19-76; higher scores indicate high prevelance and severity of adverse events. (NCT00522418)
Timeframe: Change from baseline up to 12 months

Change From Baseline in QOLIE-89 Measures: Subgroup Analysis of Population With Baseline Adverse Event Profile Score >= 40

QOLIE-89 contains 17 multi-item measures of overall quality of life. Range of values 0-100. Higher scores reflect better quality of life; lower ones, worse quality of life. Adverse Events Profile (AEP) is a 19-item scale used as a systematic measure of adverse effects from antiepileptic drugs (AEDs). Scores range from 19-76; higher scores indicate high prevelance and severity of adverse events. (NCT00522418)
Timeframe: Change from baseline up to 12 months

Reviews

73 reviews available for carbamazepine and Abdominal Epilepsy