Lyrica (Pregabalin) Administered as an Add-on Therapy for Partial Seizures (LEADER).
- Conditions
- Epilepsy
- Registration Number
- NCT00288639
- Lead Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Brief Summary
The objective of study is to assess the clinical improvement (change in seizure frequency), safety, and tolerability of subjects with partial seizures following adjunctive therapy of pregabalin BID (150 to 600 mg/day titration) in addition to existing standards AEDs.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 98
- Outpatients equal to or greater than 18 years of age with diagnosis of epilepsy with partial seizures having minimum of two partial seizures during a two month period before the baseline visit
- Having a clinical history of epilepsy and AED treatment at least 1 year prior to inclusion
- AED or Seizures/Epilepsy Related Exclusions:having a treatable cause of seizures
- Having absences seizures
- Having had status epileptics within the year prior to inclusion
- Having a progressive neurological or systematic disorder
- Having known significant renal or hepatic dysfunction
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Percentage Change in Partial Seizure Frequency (All Partial Seizure Types) Between Baseline and the 12 Week Observation Period 8 week baseline period & 12 week treatment observation period Percentage change from baseline=\[(12 week treatment observation period seizure frequency rate minus 8 week baseline period seizure frequency rate)/ 8 week baseline period seizure frequency rate\] x 100. Seizure frequencies per 28-day period: = (total # of partial seizures in period x 28 / (total # of days in period).
- Secondary Outcome Measures
Name Time Method Percentage Change in Partial Seizure Frequency (All Partial Seizure Types) Between Baseline and the Whole 21 Week Open-label Treatment Period. 8 week baseline period and 21 week treatment period Percentage change from baseline = ((21 weeks-8 weeks)/8 weeks)\*100. Negative mean R-Ratios and associated 95% CIs that do not include zero indicate reduction in partial seizure frequency.
Percentage Change in Partial Seizure Frequency (All Partial Seizure Types) Between the 8 Week Baseline Period and 4 Week Intervals During the 21 Week Open-label Treatment Period. 8 week baseline period and 21 week treatment period Percentage change from baseline = \[(4 week seizure frequency minus 8 week baseline) / (8 week baseline seizure frequency)\] x 100. Negative mean R-Ratios and associated 95% CIs that do not include zero indicate reduction in partial seizure frequency.
Number of Subjects Seizure-free last 4 weeks & whole 12 week treatment observation period Count of subjects seizure free during the period.
Reduction in Partial Seizure Frequency Between Baseline and the Final 4 Weeks of the Observation Period. 8 week baseline observation period & last 4 weeks of observation period Number of subjects with at least a 50% or 75% reduction in partial seizure frequency between baseline and treatment period.
Subjects Achieving Seizure Freedom During Observation Period Day 147 from the first dose of study drug Number of subjects achieving seizure freedom (no seizures) during last 4 weeks or duration of 12 week observation period.
Change in Partial Seizure Frequency (All Partial Seizure Types) Between Baseline and the 12 Week Observation Period Categorized by Baseline Seizure Frequency 8 week baseline observation period & 12 week treatment observation period Percentage change from baseline = ((12 weeks - 8 weeks)/8 weeks)\*100. Negative mean R-Ratios and associated 95% CIs that do not include zero indicate reduction in partial seizure frequency.
Impression of Change in Overall Status Using the Patient Global Impression of Change (PGIC) End of 21-week treatment The PGIC is a patient-rated instrument that measures change in patient's overall status on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).
Subjects With Categorical Impression of Change in Overall Status Using the Clinical Global Impression of Change (CGIC) End of 21-week treatment The CGIC is a clinician's judgment of the overall change in the patient's condition over a defined period on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).
Changes From Baseline in Medical Outcomes Study (MOS) Sleep Scale Scores Baseline, end of 21-week treatment Subjects recall sleep related activities over the previous 4 weeks. Low scores reflect greater impairment (except sleep adequacy, optimal sleep, \&quantity). Range = 0 - 100 for Sleep Disturbance, Snoring, Awaken Short of Breath, Sleep Adequacy, Somnolence, \& Sleep Problems Index. Quantity of Sleep Range = 0 - 24. Optimal Sleep Range 0 - 1.
Change From Baseline in Hospital Anxiety and Depression Scale(HADS) Depression and Anxiety Symptoms Subscales Between Baseline and Week 21. Baseline, End of 21-week treatment Change in total HADS score between Baseline and Week 21. Each of the 14 items is scored 0, 1, 2 or 3 where a score of 3 corresponds to the most anxious/depressed. 7-item depression and 7-item anxiety subscales are summed; each resulting in a total score of 0-21.
Number of Subjects With a Weight Gain at End of Treatment of at Least 7% Relative to Baseline Baseline, End of 21-week treatment Count of subjects with a weight gain of at least 7 percent relative to baseline.
Subjects Assessment of Optimal Sleep Baseline, End of 21-week treatment Number of subjects that responded optimal or non-optimal sleep in Optimal Sleep subscale of Medical Outcomes Study (MOS) Sleep scale.
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇬🇷Thessaloniki, Greece