gamma-aminobutyric acid and Abdominal Epilepsy

gamma-aminobutyric acid has been researched along with Abdominal Epilepsy in 259 studies

gamma-Aminobutyric Acid: The most common inhibitory neurotransmitter in the central nervous system.
gamma-aminobutyric acid : A gamma-amino acid that is butanoic acid with the amino substituent located at C-4.

Research

Studies (259)

Authors

Clinical Trials (13)

Trial Overview

Trial Outcomes

Mean Time on Pregabalin Monotherapy

(NCT00524030)
Timeframe: Week 2 to Week 20

Percentage of Participants Completing 20 Weeks of Double-Blind Treatment

(NCT00524030)
Timeframe: Randomization up to Week 20

Percentage of Participants in the Pregabalin 150 mg/Day Treatment Group Discontinuing the Study Due to at Least 1 Pre-Defined Seizure Exit Criteria

Participants who discontinued due to: episode of SE; SGTC seizure if none within 2 years of study entry; 28-day study seizure rate during DBP >2 times Max 28-day study seizure rate during BLP; 2-day study seizure rate during DBP >2 times Max 2-day study seizure rate during BLP; or unacceptable clinically significant increase in frequency/intensity of seizure activity. Determined as exit rate, defined as (1-KM product limit estimate for survival function) * 100% (NCT00524030)
Timeframe: Week 2 up to Week 18

Percentage of Participants in the Pregabalin 600 mg/Day Treatment Group Discontinuing the Study Due to at Least 1 Pre-Defined Seizure Exit Criteria

Participants who discontinued due to: episode of status epilepticus (SE); secondarily generalized tonic-clonic (SGTC) seizure if none within 2 years of study entry; 28-day study seizure rate during double-blind phase (DBP) greater than (>)2 times maximum (Max) 28-day study seizure rate during baseline phase (BLP); 2-day study seizure rate during DBP >2 times Max 2-day study seizure rate during BLP; or unacceptable clinically significant increase in frequency/intensity of seizure activity. Determined as exit rate:(1-Kaplan-Meier [KM] product limit estimate for survival function) * 100% (NCT00524030)
Timeframe: Week 2 up to Week 18

Pregabalin Exposure-Response Analysis

Percentage of participants predicted to exit the study due to any seizure exit criteria at Day 126. The exit rate at Day 126 was predicted using the final model (log normal distribution with respect to treatment group) and the parameter estimates. (NCT00524030)
Timeframe: Day 126

Percentage of Participants Who Met Protocol-Specified Exit Events

Percentage of participants experiencing any of the following (could have had more than 1): 1) episode of SE; 2) SGTC seizure if none had been experienced within 2 years of study entry; 3) 28-day study seizure rate during DBP >2 times the Max 28-day study seizure rate during BLP; 4) 2-day study seizure rate during the DBP >2 times the Max 2-day study seizure rate during BLP; or 5) unacceptable clinically significant increase in frequency/intensity of seizure activity (NCT00524030)
Timeframe: Week 2 up to Week 18

Percentage of Seizure-Free Participants by Study Phase

Percentage of participants who were seizure-free during the last 28 days on double-blind study medication (monotherapy phase, Days 112-140), during the monotherapy portion of the double-blind treatment phase (Days 56-140), and during all of the double-blind treatment phase (Days 1-140) (NCT00524030)
Timeframe: Day 1 up to Day 140

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 in Hospital Anxiety and Depression Scale - Anxiety (HADS-A) Total Score at Week 14

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. (NCT01262677)
Timeframe: Baseline, Week 14

Change From Baseline in Hospital Anxiety and Depression Scale - Depression (HADS-D) Total Score at Week 14

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. (NCT01262677)
Timeframe: Baseline, Week 14

Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Disturbance Score at Week 14

Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = greater intensity of attribute. (NCT01262677)
Timeframe: Baseline, Week 14

Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Problems Index II Score at Week 14

Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = greater intensity of attribute. (NCT01262677)
Timeframe: Baseline, Week 14

Change From Baseline in MOS-SS - Awaken Short of Breath or With Headache Score at Week 14

Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = greater intensity of attribute. (NCT01262677)
Timeframe: Baseline, Week 14

Change From Baseline in MOS-SS - Quantity of Sleep (Hours) at Week 14

Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = greater intensity of attribute. (NCT01262677)
Timeframe: Baseline, Week 14

Change From Baseline in MOS-SS - Sleep Adequacy Score at Week 14

Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = greater intensity of attribute. (NCT01262677)
Timeframe: Baseline, Week 14

Change From Baseline in MOS-SS - Sleep Problems Index I Score at Week 14

Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = greater intensity of attribute. (NCT01262677)
Timeframe: Baseline, Week 14

Change From Baseline in MOS-SS - Sleep Somnolence Score at Week 14

Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = greater intensity of attribute. (NCT01262677)
Timeframe: Baseline, Week 14

Change From Baseline in MOS-SS - Snoring Score at Week 14

Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = greater intensity of attribute. (NCT01262677)
Timeframe: Baseline, Week 14

Frequency of Secondary Generalized Tonic-clonic Seizures (SGTC) During the Double-blind Treatment Phase

Seizures were recorded and documented in a daily Seizure Diary by the participants, family member, caregiver, or legal guardian. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) were not counted toward eligibility, or in the primary or secondary efficacy analyses. (NCT01262677)
Timeframe: Week 0 to Week 14

Log Transformed 28-day SGTC Rate for All SGTCs During the Double-blind Maintenance Phase

Seizures were recorded and documented in a daily Seizure Diary by the participants, family member, caregiver, or legal guardian. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) were not counted toward eligibility, or in the primary or secondary efficacy analyses. Natural logarithm of the 28-day seizure rate was reported in this outcome measure. (NCT01262677)
Timeframe: Week 2 to Week 14

Loge 28-day Seizure Rate for All Partial Onset Seizures During the Double-blind Maintenance Phase

Seizures were recorded and documented in a daily Seizure Diary by the participants, family member, caregiver, or legal guardian. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) were not counted toward eligibility, or in the primary or secondary efficacy analyses. Natural logarithm of the 28-day seizure rate was reported in this outcome measure. (NCT01262677)
Timeframe: Week 2 to Week 14

Percent of Participants Reporting Optimal Sleep on the MOS-SS - Optimal Sleep Subscale

Optimal sleep was considered between 7 to 8 hours of average sleep per night inclusive, while average sleep less than or greater than the 7 to 8 hour of average sleep per night was non-optimal. (NCT01262677)
Timeframe: Week 14

Percentage Change From Baseline in 28-day Partial Seizure Rate During the Double-blind Treatment Phase

Seizures were recorded and documented in a daily Seizure Diary by the participants, family member, caregiver, or legal guardian. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) were not counted toward eligibility, or in the primary or secondary efficacy analyses. Natural logarithm of the 28-day seizure rate was reported in this outcome measure. (NCT01262677)
Timeframe: Week 0 to Week 14

Percentage of Participants With ≥50% Reduction in 28-day SGTC Seizure Rate From Baseline During the Double-blind Treatment Phase

Seizures were recorded and documented in a daily Seizure Diary by the participants, family member, caregiver, or legal guardian. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) were not counted toward eligibility, or in the primary or secondary efficacy analyses. (NCT01262677)
Timeframe: Week 0 to Week 14

Benefit, Satisfaction, and Willingness to Continue Measure (BSW): Benefit From Treatment Question

The BSW consisted of 3 single-item measures designed to capture the participant's perception of the effect of treatment in terms of the relative benefit, their satisfaction, and their intention or willingness to continue on therapy. The BSW was read aloud to the participant by the investigator or designated center personnel and then was given to the participant to complete independently. (NCT01262677)
Timeframe: Week 14

BSW: Satisfaction From Treatment Question

The BSW consisted of 3 single-item measures designed to capture the participant's perception of the effect of treatment in terms of the relative benefit, their satisfaction, and their intention or willingness to continue on therapy. The BSW was read aloud to the participant by the investigator or designated center personnel and then was given to the participant to complete independently. (NCT01262677)
Timeframe: Week 14

BSW: Willingness to Continue Question

The BSW consisted of 3 single-item measures designed to capture the participant's perception of the effect of treatment in terms of the relative benefit, their satisfaction, and their intention or willingness to continue on therapy. The BSW was read aloud to the participant by the investigator or designated center personnel and then was given to the participant to complete independently. (NCT01262677)
Timeframe: Week 14

Log Transformed (Loge) 28-day Seizure Rate for All Partial Onset Seizures During the Double-blind Treatment Phase

Seizures were recorded and documented in a daily Seizure Diary by the participants, family member, caregiver, or legal guardian. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) were not counted toward eligibility, or in the primary or secondary efficacy analyses. Natural logarithm of the 28-day seizure rate was reported in this outcome measure. (NCT01262677)
Timeframe: Week 0 to Week 14

Percentage of Participants With a ≥50% Reduction in the 28-day Partial Seizure Rate From Baseline During the Double-blind Treatment Phase

Seizures were recorded and documented in a daily Seizure Diary by the participants, family member, caregiver, or legal guardian. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) were not counted toward eligibility, or in the primary or secondary efficacy analyses. Participants who had a ≥50% reduction in the 28-day partial seizure rate from baseline were defined as a responder, otherwise they were default as a non-responder. (NCT01262677)
Timeframe: Week 0 to Week 14

Percentage of Participants With a Relevant Increase in Sitting Blood Pressure (BP) From Baseline During the Double-blind Treatment Phase

Physical examinations included general appearance (including hight at baseline), vital sign (sitting heart rate and sitting blood pressure), weight, skin (examination for the presence of rash), HEENT (examinatin of head, eyes, ears, nose and throat), chest (ausculation of lung fields), cardiovascular (ausculatin of heart sounds (S1 and S2) and for the presence of murmurs, gallops, or rubs), gastrointestinal(abdominal rigidity and tenderness), an extremities (e.g. edema). (NCT01262677)
Timeframe: Day 1 to Week 15

Percentage of Participants With Corrected QT (QTc) Interval Greater Than or Equal to 450 ms

The original ECG was reviewed by the investigator and kept on site as part of source documentation. A central ECG reader was also used for this study. QT interval corrected using the Fridericia formula (QTcF) and QT interval corrected using the Bazett's formula (QTcB) were calculated. (NCT01262677)
Timeframe: Week 15

Percentage of Participants With Laboratory Test Abnormalities During the Study

Laboratory samples in hematology, chemistry, and urinalysis were analyzed by a cental laboratory. Any laboratory value that was identified as clinically significant was reported as an AE. LLN: Lower limit of normal, ULN: Uper limit of normal, RBC: Red Blood Cell, WBC: White Blood Cell, AST: Aspartate Aminotransferase, ALT: Alanine Aminotransferase, BUN: Blood Urea Nitrogen (NCT01262677)
Timeframe: Day 1 to Week 15

Percentage of Participants With New or Intensified Neurological Examination Findings During the Double-blind Treatment Phase

Neurological examinations included level of consciousness, mental status, cranial nerve assessment, muscle strength, reflexes, pin prick and vibratory sensation (the latter using a 128-Hz tuning fork), coordination and gait. (NCT01262677)
Timeframe: Day 1 to Week 15

Percentage of Participants With New or Intensified Physical Examination Findings During the Double-blind Treatment Phase

Physical examinations included general appearance (including hight at baseline), vital sign (sitting heart rate and sitting blood pressure), weight, skin (examination for the presence of rash), HEENT (examinatin of head, eyes, ears, nose and throat), chest ausculation of lung fields), cardiovascular (ausculatin of heart sounds (S1 and S2) and for the presence of murmurs, gallops, or rubs), gastrointestinal (abdominal rigidity and tenderness), an extremities (e.g. edema). Clinically significant physical examination abnormalities were considered as adverse events based on investigator's discretion. (NCT01262677)
Timeframe: Day 1 to Week 15

Percentage of Participants With Relevant ECG Interval-increases From Baseline During the Double-blind Treatment Phase

The original ECG was reviewed by the investigator and kept on site as part of source documentation. A central ECG reader was also used for this study. 25/50% represents ≥25% or ≥50% increase over baseline respectively, based on cut points. Cut points are 100 ms for QRS and 200 ms for PR. (NCT01262677)
Timeframe: Week 15

Percentage of Participants With Self-injurious or Suicidal Ideation or Behavior on Columbia Classification Algorithm of Suicide Assessment (C-CASA)

C-CASA is described as a standardized suicidal rating system. The C-CASA has eight categories (4 suicidal events: completed suicide, suicide attempt, preparatory act toward imminent suicidal behavior (PAISB), and suicidal ideation; 2 nonsuicidal events: self-injurious behavior, no suicidal intent (SIB-NSI) and other no deliberate self-harm, and 2 indeterminate or potentially suicidal events: self-injurious behavior, suicidal intent unknown and not enough information) that distinguish suicidal events from nonsuicidal events and indeterminate or potentially suicidal events. (NCT01262677)
Timeframe: Week -8 (Screening), Week 0 (Baseline), and Week 14 (double-blind treatment phase)

Apparent Oral Clearance (CL/F): Multiple-Dose Analysis

Clearance (CL) of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed (F). Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. CL/F for participants who received pregabalin from Day 1 to Day 8 morning is reported (multiple-dose participants). (NCT00437281)
Timeframe: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8

Apparent Oral Clearance (CL/F): Single-Dose Analysis

Clearance (CL) of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed (F). Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. CL/F for participants who received matching placebo from Day 1 to Day 7 and pregabalin on Day 8 morning is reported (single-dose participants). (NCT00437281)
Timeframe: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8

Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau): Multiple-Dose Analysis

Area under the curve from time zero to the end of dosing interval (AUCtau), where dosing interval was 12 hours, for participants who received pregabalin from Day 1 to Day 8 morning is reported (multiple-dose participants). Results are normalized to individual participant's Day 8 dose. (NCT00437281)
Timeframe: Pre-dose, 0.5, 1, 2, 4, 8, 12 hours post-dose on Day 8

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]: Single-Dose Analysis

AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). AUC (0 - ∞) for participants who received matching placebo from Day 1 to Day 7 and pregabalin on Day 8 morning is reported (single-dose participants). Results are normalized to individual participant's Day 8 dose. (NCT00437281)
Timeframe: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8

Maximum Observed Plasma Concentration (Cmax): Multiple-Dose Analysis

Cmax for participants who received pregabalin from Day 1 to Day 8 morning is reported (multiple-dose participants). Results are normalized to individual participant's Day 8 dose. (NCT00437281)
Timeframe: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8

Maximum Observed Plasma Concentration (Cmax): Single-Dose Analysis

Cmax for participants who received matching placebo from Day 1 to Day 7 and pregabalin on Day 8 morning is reported (single-dose participants). Results are normalized to individual participant's Day 8 dose. (NCT00437281)
Timeframe: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8

Number of Participants With Clinically Significant Change in Physical and Neurological Findings

Full physical examination included examination of the abdomen, breasts, lungs, lymph nodes, mouth, genitourinary, musculoskeletal and neurological systems, skin, extremities, head, heart, ears, eyes, neck, nose, ocular fundi, throat and thyroid gland. The neurological exam was performed by a pediatric neurologist or qualified investigator. (NCT00437281)
Timeframe: Baseline up to 7 days post-last dose of study medication

Plasma Decay Half-Life (t1/2): Multiple-Dose Analysis

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. t1/2 for participants who received pregabalin from Day 1 to Day 8 morning is reported (multiple-dose participants). (NCT00437281)
Timeframe: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8

Plasma Decay Half-Life (t1/2): Single-Dose Analysis

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. t1/2 for participants who received matching placebo from Day 1 to Day 7 and pregabalin on Day 8 morning is reported (single-dose participants). (NCT00437281)
Timeframe: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8

Renal Clearance (CLr): Multiple-Dose Analysis

Renal clearance is the volume of plasma from which the drug is completely removed by the kidney in a given amount of time. CLr for participants who received pregabalin from Day 1 to Day 8 morning is reported (multiple-dose participants). (NCT00437281)
Timeframe: 0 to 12 hours post-dose, 12 to 24 hours post-dose on Day 8

Renal Clearance (CLr): Single-Dose Analysis

Renal clearance is the volume of plasma from which the drug is completely removed by the kidney in a given amount of time. CLr for participants who received matching placebo from Day 1 to Day 7 and pregabalin on Day 8 morning was to be reported (single-dose participants). (NCT00437281)
Timeframe: 0 to 12 hours post-dose, 12 to 24 hours post-dose on Day 8

Time to Reach Maximum Observed Plasma Concentration (Tmax): Multiple-Dose Analysis

Tmax for participants who received pregabalin from Day 1 to Day 8 morning is reported (multiple-dose participants). (NCT00437281)
Timeframe: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8

Time to Reach Maximum Observed Plasma Concentration (Tmax): Single-Dose Analysis

Tmax for participants who received matching placebo from Day 1 to Day 7 and pregabalin on Day 8 morning is reported (single-dose participants). (NCT00437281)
Timeframe: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8

Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment

Analysis for severity of AEs was performed separately for double-blind and open-label treatment. AE = any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. AEs were classified as mild, moderate and severe based on severity assessment: Mild = no interference with participant's usual function; Moderate = some interference with participant's usual function; Severe = significant interference with participant's usual function. Treatment-emergent events for double-blind treatment included events between baseline and Day 7 that were absent before treatment or that worsened relative to pretreatment state. Participants may experience more than 1 AE. (NCT00437281)
Timeframe: Baseline to Day 7

Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment

Analysis for severity of AEs was performed separately for double-blind and open-label treatment. AE = any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. AEs were classified as mild, moderate and severe based on severity assessment: Mild = no interference with participant's usual function; Moderate = some interference with participant's usual function; Severe = significant interference with participant's usual function. Treatment-emergent events for open-label treatment included events between Day 8 and 28 days after the open-label dose that were absent before treatment or that worsened relative to pretreatment state. Participants may experience more than 1 AE. (NCT00437281)
Timeframe: Day 8 up to 28 days after open-label dose of study medication

Percent Change From Baseline in 28-day Seizure Frequency at Week 21.

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. Total partial seizure is defined as the total number of (simple partial seizure + complex partial seizure + secondary generalized tonic clonic seizure [SGTC]). (NCT00537940)
Timeframe: 6 weeks Baseline, 21 weeks through End of MP for 27 weeks

Reduction in Proportion of the 28-day SGTC Seizure Rate Over the Total Partial Seizure Rate at Week 21.

SGTC Responder is defined as a participant who shows reduction from Baseline to double-blind phase in proportion of 28-Day SGTC Seizure Rate to 28-Day All Partial Seizure Rate. (NCT00537940)
Timeframe: 6 weeks Baseline, 21 weeks through End of MP for 27 weeks

Change From Baseline in the 28-day Secondarily Generalized Tonic-clonic (SGTC) Seizure Frequency at Week 21.

Change in SGTC = (Proportion of SGTC/All Partial Seizure rate during at the double-blind phase) - (Proportion of SGTC/All Partial Seizure rate at Baseline). Negative values indicate reduction from baseline. (NCT00537940)
Timeframe: 6 weeks Baseline, 21 weeks through End of MP for 27 weeks

Hospital Anxiety and Depression Scale (HADS) Score.

HADS: participant rated questionnaire with 2 subscales. Hospital Anxiety and Depression Scale - anxiety (HADS-A) assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); Hospital Anxiety and Depression Scale - depression (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. (NCT00537940)
Timeframe: Baseline, Week 21

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. (NCT00537940)
Timeframe: Baseline, Week 21

Percentage of Participants With 50% Reduction From Baseline in 28-day Seizure Rate at Week 21.

Participants who had at least 50% reduction in seizure frequency from Baseline to double-blind treatment (TP + MP) were considered as 50% responders. If percent change from baseline <= -50 then responder rate = 1 (yes) otherwise responder rate = 0 (no). (NCT00537940)
Timeframe: 6 weeks Baseline, 21 weeks through End of MP for 27 weeks

Percentage of Participants With 75% Reduction From Baseline in 28-day Seizure Rate at Week 21.

Participants who had at least 75% reduction in seizure frequency from Baseline to double-blind treatment (TP + MP) were considered as 75% responders. If percent change from baseline <= -75 then 75% responder rate = 1 (yes) otherwise responder rate = 0 (no). Total partial seizure is defined as the total number of (simple partial seizure + complex partial seizure + SGTC). (NCT00537940)
Timeframe: 6 weeks Baseline, 21 weeks through End of MP for 27 weeks

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. (NCT00537940)
Timeframe: Baseline, Week 21

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 MP. Same participant could be seizure free for a specific type of seizure but not necessarily for the other types of seizure. (NCT00537940)
Timeframe: 6 weeks Baseline, 21 weeks through End of MP for 27 weeks

Exit Due to Adverse Events During the Double-blind Treatment Phase (Including Dose Escalation Phase)

Number of participants who exited the study due to adverse events during the double-blind treatment period. Time in days, from first day of study treatment to day of exit from the study due to an adverse event (ie, last day on study medication) during the double blind treatment period (including dose escalation phase) was inestimable. Observations with other reasons for exiting or participants who did not exit the study were right censored as of the last day on study medication. (NCT00280059)
Timeframe: Week 0 to Week 56

Exit Due to Any Reason After 4-week Dose Escalation Phase

Number of participants who exited the study due to any reason after the 4-week dose escalation phase. Time in days, from first day of study treatment to day of exit after Day 28 of the study due to any reason (ie, last day on study medication) was inestimable. Participants who did not exit or did not reach this phase were right censored as of the last day on study medication. (NCT00280059)
Timeframe: Week 4 up to Week 56

Exit Due to Lack of Efficacy After 4-week Dose Escalation Phase

Number of participants who exited the study due to lack of efficacy after the 4-week dose escalation phase. Time in days, from first day of study treatment to day of exit due to lack of efficacy after Day 28 of the escalation phase (ie, last day on study medication) was inestimable. Participants who did not exit or exited for a different reason were right censored as of the last day on study medication. (NCT00280059)
Timeframe: Week 4 up to Week 56

Exit for Any Reason During the Double-blind Treatment Phase (Including Dose Escalation Phase)

Number of participants who exited the study for any reason during the double blind treatment phase. Time in days, from first day of study treatment to day of exit from the study due to any reason (ie, last day on study medication) was inestimable. Participants who did not exit the study were right censored as of the last day on study medication. (NCT00280059)
Timeframe: Week 0 to Week 56

Percentage of Participants Who Achieved at Least 6 Consecutive Months of Seizure Freedom (Responders) by Final Dosage Levels and Treatment Group

Responder = participant who achieved at least 6-months of seizure freedom (all seizures) after Week 4, and up to Week 56. Dose Level defined as last total-daily-dose received after Week 4, and up to Week 56. (NCT00280059)
Timeframe: Week 5 up to Week 56

Percentage of Seizure-free Participants (Responders) During Efficacy Assessment Phase

Responders = participants who achieved any 6 consecutive months (>182 days) of seizure-freedom (absence of partial seizures, generalized seizures and unclassified epileptic seizures) during the 52 week efficacy assessment phase. (NCT00280059)
Timeframe: Week 5 up to Week 56

Time to 6 Consecutive Months of Seizure-freedom After 4-week Dose Escalation Phase: All Seizures

Time in days, from first day of study medication to the first 6 months of seizure freedom after Day 28. Participants who did not achieve 6 months seizure freedom after Day 28 were censored from analysis. (NCT00280059)
Timeframe: Week 4 up to Week 56

Time to First Seizure After the 4-Week Dose Escalation Phase

Time in days, from first day of study treatment to the day of first seizure after Day 28 of the escalation phase (ie, last day on study medication). Participants who did not reach this phase or who did not have a seizure after Day 28 were right censored from the analysis as of the last day on study medication. (NCT00280059)
Timeframe: Week 4 up to Week 56

Change From Baseline to Week 56 in Hospital Anxiety and Depression Scale (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; 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 symptoms. Scores relative to start of randomized treatment. (NCT00280059)
Timeframe: Baseline to Week 56

Mean Monthy Seizure Frequency of Responders for the Months After Achieving 6 Consecutive Months of Seizure Freedom: All Partial Seizures

All partial seizures include complex partial seizures, simple partial seizures, and partial seizures evolving to secondarily generalized seizures. Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period * 28. Responder = participant who achieved at least 6 months of seizure freedom after Week 4 and up to Week 56. Monthly seizure frequency measured from day of achievement of 6 months of seizure freedom. (NCT00280059)
Timeframe: Month 1 through Month 9 (after 6 months seizure freedom achieved)

Mean Monthy Seizure Frequency of Responders for the Months After Achieving 6 Consecutive Months of Seizure Freedom: All Seizures

Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period * 28. Responder = participant who achieved at least 6 months of seizure freedom after Week 4 and up to Week 56. Monthly seizure frequency measured from day of achievement of 6 months of seizure freedom. (NCT00280059)
Timeframe: Month 1 through Month 9 (after 6 months seizure freedom achieved)

Mean Monthy Seizure Frequency: All Partial Seizures

All partial seizures include complex partial seizures, simple partial seizures, and partial seizures evolving to secondarily generalized seizures. Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period * 28. Month of time = number of months after Week 4 (Dose Escalation). (NCT00280059)
Timeframe: Baseline up to Week 60

Mean Monthy Seizure Frequency: All Seizures

Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period * 28. Month of time = number of months after Week 4 (Dose Escalation). (NCT00280059)
Timeframe: Baseline up to Week 60

Median Monthy Seizure Frequency of Responders for the Months After Achieving 6 Consecutive Months of Seizure Freedom: All Partial Seizures

All partial seizures include complex partial seizures, simple partial seizures, and partial seizures evolving to secondarily generalized seizures. Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period * 28. Responder = participant who achieved at least 6 months of seizure freedom after Week 4 and up to Week 56. Monthly seizure frequency measured from day of achievement of 6 months of seizure freedom. (NCT00280059)
Timeframe: Month 1 through Month 9 (after 6 months seizure freedom achieved)

Median Monthy Seizure Frequency of Responders for the Months After Achieving 6 Consecutive Months of Seizure Freedom: All Seizures

Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period * 28. Responder = participant who achieved at least 6 months of seizure freedom after Week 4 and up to Week 56. Monthly seizure frequency measured from day of achievement of 6 months of seizure freedom. (NCT00280059)
Timeframe: Month 1 through Month 9 (after 6 months seizure freedom achieved)

Median Monthy Seizure Frequency: All Partial Seizures

All partial seizures include complex partial seizures, simple partial seizures, and partial seizures evolving to secondarily generalized seizures. Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period * 28. Month of time = number of months after Week 4 (Dose Escalation). (NCT00280059)
Timeframe: Baseline up to Week 60

Median Monthy Seizure Frequency: All Seizures

Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period * 28. Month of time = number of months after Week 4 (Dose Escalation). (NCT00280059)
Timeframe: Baseline up to Week 60

Medical Outcomes Study Sleep Scale (MOS-SS): Optimal Sleep Subscale

MOS-SS: subject-rated instrument used to assess the key constructs of sleep over the past week; assesses sleep quantity and quality and is comprised 12 items yielding 7 subscale scores and 2 composite index scores. Optimal Sleep subscale is derived from sleep quantity average hours of sleep each night during the past week. Number of subjects with response Optimal if sleep quantity was 7 or 8 hours of sleep per night, and Non-optimal if average sleep was less than or greater than 7 to 8 hours per night. Analysis assesses the MOS-Sleep scale relative to the start of randomized treatment. (NCT00280059)
Timeframe: Week 8, Week 32, and Week 56

58-week Retention Rate Measured by the Number of Drop Outs Due to Adverse Events or Seizures From Day 1 of Treatment

(NCT00438451)
Timeframe: 58 weeks

Percentage of Patients Remaining Seizure Free at Week 58 (Visit 6)

Percentage of patients experiencing no seizures until week 58 (Visit 6) and did not discontinue the study until week 58. (NCT00438451)
Timeframe: week 58

Percentage of Patients Remaining Seizure-free at Week 30 (Visit 4)

Percentage of patients experiencing no seizures until week 30 (Visit 4) and did not discontinue the study until week 30. (NCT00438451)
Timeframe: Week 30

Proportion of Seizure-free Days During the Maintenance Phase for Subjects Who Enter the Maintenance Phase

(NCT00438451)
Timeframe: 52 weeks

Results of Cognitive Testing (EpiTrack© by UCB) - Score at V6

EPITrack-Score shows the performance of attention and executive functions. Higher values indicate a better performance. The results of EPITrack Score ranges between 7 and 45. (NCT00438451)
Timeframe: week 58

The Absolute Seizure Frequency During the Maintenance Phase (Weeks 7 - 58)

"Seizure frequency was assessed by investigators in the CRF at the Visits V3, V4, V5 and V6.~The absolute seizure frequency during the maintenance phase was defined as the sum of those entries." (NCT00438451)
Timeframe: over 52 weeks

The Time (in Days) to First Break-through Seizure (From Day 1 of Treatment)

(NCT00438451)
Timeframe: over the whole duration of 58 weeks

Time to Drop Out

number of days between randomization and premature discontinuation of the study (NCT00438451)
Timeframe: 58 weeks

Portland Neurotoxicity Scale (PNS) at V6

"The PNS is a 15-item scale. Each item can be scored from 1 to 9. There are a total score (includes all items, range:15 to 135) and two subscores: The cognitive toxicity subscore (10 items: Energy Level, Memory, Interest, Concentration, Forgetfulness, Sleepliness, Moodiness, Alertness, Attention Span, Motivation, range:10 to 90) and the somatomoto subscore (5 items: Vision, Walking, Coordination, Tremor, Speech, range:5-45). The score is calculated by taking the mean of all non-missing values times the number of items.~Lower values indicate better quality of life." (NCT00438451)
Timeframe: at week 58

QOLIE-31 (Quality Of Life In Epilepsy) Results at V6

The QOLIE-31 is a 31 item score that measures the quality of life in epilepsy (each item with a range of 0 to 100). There are 7 sub-scores seizure worry (items 11,21,22,23,25), overall quality of life (items 1,14), emotional well-being (items 3,4,5,7,9), energy/fatigue (items 2,6,8,10), cognitive functioning (items 12,15,16,17,18,26), medication effects (items 24,29,30) and social functioning (13,19,20,27,28). These scores were combined to a total score by Total score = seizure worry*0.08 + overall quality of life*0.14 + emotional well-being*0.15 + energy/fatigue*0.12 + cognitive functioning*0.27 + medication effects*0.03 + social functioning*0.21 For all scores, higher values indicate better quality of life. Each score has a possible range from 0 to 100. (NCT00438451)
Timeframe: 58 weeks, final visit

Results of Cognitive Testing (EpiTrack© by UCB) - Categories at V6

"Evaluation of current testing at V6:~≥29 score points: Inconspicuous; 26 to 28 score points: Borderline;~≤25 score points: Impaired" (NCT00438451)
Timeframe: 58 weeks

Results of Cognitive Testing (EpiTrack© by UCB) - Changes to Baseline (V0) at Week 58 (V6)

"Evaluation of Changes~Changes in the EpiTrack® Score were categorized as follows:~≥5 score points: Improved;~-3 to 4 score points: Unchanged;~≤-4 score points: Worsened" (NCT00438451)
Timeframe: week 58

Maximum Change in Pain Score From Baseline Between Pregabalin and Placebo Across the 2 Cycles

"Compare the maximum change in pain score from baseline between pregabalin and placebo within cycle 1 and across the 2 cycles.~The ten-point numerical scale is scored from 0 to 10. They will use this scale to rate their pain (and separately bone/joint pain) with 0 signifying no pain and 10 signifying the worst pain you can imagine. Each patient will be assessed regularly, including: before therapeutic intervention (i.e. at consent/screening), first day of chemotherapy administration (during cycles 1 & 2), 4 days after pegfilgrastim administration (during cycles 1 & 2), and 8 days after pegfilgrastim administration (during cycles 1 & 2)." (NCT03407430)
Timeframe: Up to 12 weeks

Maximum Neuropathic Pain Score Between Pregabalin and Placebo Across the 2 Cycles

"Compare the maximum neuropathic pain score between pregabalin and placebo within cycle 1 and across the 2 cycles.~The ID Pain scale (also know as the Identify Pain scale) is a 6-item, participant-completed screening tool designed to help differentiate nociceptive and neuropathic pain. This pain score also helps to evaluate the presence/absence of neuropathic pain at a given point of time.~Did the pain feel like pins and needles?~Did the pain feel hot/burning?~Did the pain feel numb?~Did the pain feel like electrical shocks?~Is the pain made worse with the touch of clothing or bed sheets?~Is the pain limited to your joints?~A yes response to questions 1-5 are scored as 1; for question 6, a yes is scored as -1. As such, higher scores (approaching 5) signify worse outcomes. The scale's total range for a patient is -1 to 5." (NCT03407430)
Timeframe: Up to 12 weeks

Number of Days of Breakthrough Analgesic Use Between Pregabalin and Placebo Across the 2 Cycles

"Compare the number of days of breakthrough analgesic use between pregabalin and placebo within cycle 1 and across the 2 cycles.~The number of days of breakthrough analgesic use (i.e additional pain medication being required) is evaluated based on participant-provided medication logs kept during study treatment. If additional pain medication outside of their normal pain control regimen was reported, this day counts as 1. The total days for each patient are then reported, with a total range from zero to 14 (for patients with breast cancer) or zero to 21 (for patients with a lymphoma)." (NCT03407430)
Timeframe: Up to 12 weeks

Number of Patients Who Have an Increase in Pain Score of ≥ 3 From Baseline Through the End of Study Medication in Cycle 1

"Compare the proportion of patients who have an increase in pain score of ≥ 3 from baseline through the end of study medication in cycle 1 between Arm A and Arm B.~The ten-point numerical scale is scored from 0 to 10. They will use this scale to rate their pain (and separately bone/joint pain) with 0 signifying no pain and 10 signifying the worst pain you can imagine." (NCT03407430)
Timeframe: Up to 12 weeks

Number of Subjects That Experienced a Grade 2 or Higher Adverse Events When Taking Pregabalin

CTCAE The NCI Common Terminology Criteria for Adverse Events is a descriptive terminology utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE. (NCT03407430)
Timeframe: Up to 12 weeks

Proportion of Patients Who Have an Increase in Bone/Joint Pain Score of ≥ 3 From Baseline Through the End of Study Medication in Cycle 1

"Compare the proportion of patients who have an increase in bone/joint pain score of ≥ 3 from baseline through the end of study medication in cycle 1 between Arm A and Arm B.~The ten-point numerical scale is scored from 0 to 10. They will use this scale to rate their pain (and separately bone/joint pain) with 0 signifying no pain and 10 signifying the worst pain you can imagine." (NCT03407430)
Timeframe: Up to 12 weeks

Proportion of Patients Who Have an Increase in Pain Score of ≥ 3 From Baseline Between Pregabalin and Placebo Across the 2 Cycles

"Compare the proportion of patients who have an increase in pain score of ≥ 3 from baseline between pregabalin and placebo across the 2 cycles.~The ten-point numerical scale is scored from 0 to 10. They will use this scale to rate their pain (and separately bone/joint pain) with 0 signifying no pain and 10 signifying the worst pain you can imagine." (NCT03407430)
Timeframe: Up to 12 weeks

Proportion of Patients With Severe Pain Between Pregabalin and Placebo Across the 2 Cycles

"Compare the proportion of patients with severe pain between pregabalin and placebo within cycle 1 and across the 2 cycles.~The ten-point numerical scale is scored from 0 to 10. They will use this scale to rate their pain (and separately bone/joint pain) with 0 signifying no pain and 10 signifying the worst pain you can imagine." (NCT03407430)
Timeframe: Up to 12 weeks

Reviews

63 reviews available for gamma-aminobutyric acid and Abdominal Epilepsy