Pregabalin Versus Levetiracetam In Partial Seizures
|ClinicalTrials.gov Identifier: NCT00537238|
Recruitment Status : Completed
First Posted : October 1, 2007
Results First Posted : July 11, 2013
Last Update Posted : July 11, 2013
|Condition or disease||Intervention/treatment||Phase|
|Partial Seizures||Drug: pregabalin Drug: levetiracetam||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||509 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Randomized, Double-Blind, Parallel-Group Multi-Center Comparative Flexible-Dose Study Of Pregabalin Versus Levetiracetam As Adjunctive Therapy To Reduce Seizure Frequency In Subjects With Partial Seizures|
|Study Start Date :||October 2007|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||May 2012|
|Active Comparator: B||
300, 450, 600 mg/day administered orally, BID until seizure control/improvement or intolerable side effects
|Active Comparator: A||
1000, 2000, 3000 mg/day administered orally, BID until seizure control/improvement or intolerable side effects
- Proportion of Participants With Response to Treatment [ Time Frame: Baseline up to Week 16 ]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.
- Percent Change From Baseline in 28 Day Seizure Frequency at Week 16 [ Time Frame: Baseline, 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.
- 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 [ Time Frame: Baseline, 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.
- Percentage of Participants Without Seizures [ Time Frame: Baseline up to Week 16 ]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.
- Change From Baseline in Brief Psychiatric Rating Scale - Anchored (BPRS-A) Total and Core Score at Week 7, 10, 13, 16 and Follow-up [ Time Frame: Baseline, Week 7, 10, 13, 16 and Follow-up (Day 7 of taper phase) ]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.
- Hospital Anxiety and Depression Scale (HADS) Score [ Time Frame: Baseline, Week 16 ]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.
- Medical Outcomes Study Sleep Scale (MOS-SS) Score [ Time Frame: Baseline, Week 16 ]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.
- Percentage of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) Score [ Time Frame: Baseline, Week 16 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00537238
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|Study Director:||Pfizer CT.gov Call Center||Pfizer|