This study will determine the safety and efficacy of pregabalin (Lyrica) when administered by itself (without any other anti-epileptic medication) to epilepsy subjects for the treatment of partial seizures. The duration of the trial is about 6 months.
After review of the interim analysis results, the independent Data Monitoring Committee (DMC) recommended to stop the study based on positive efficacy findings for the primary efficacy endpoint according to pre-specified stopping rules. Pfizer accepted the DMC recommendation and made the decision to stop the study on September 7, 2011.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
161
pregabalin 600 mg/day (300mg BID), duration is 20 weeks.
pregabalin 150 mg/day (75mg BID), duration is 20 weeks.
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%
Time frame: Week 2 up to Week 18
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%
Time frame: Week 2 up to Week 18
Percentage of Participants Completing 20 Weeks of Double-Blind Treatment
Time frame: Randomization up to Week 20
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
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Pfizer Investigational Site
Northport, Alabama, United States
Pfizer Investigational Site
Phoenix, Arizona, United States
Pfizer Investigational Site
Phoenix, Arizona, United States
Pfizer Investigational Site
Sun City, Arizona, United States
Pfizer Investigational Site
Fayetteville, Arkansas, United States
Pfizer Investigational Site
Fullerton, California, United States
Pfizer Investigational Site
Long Beach, California, United States
Pfizer Investigational Site
Modesto, California, United States
Pfizer Investigational Site
Murrieta, California, United States
Pfizer Investigational Site
Newport Beach, California, United States
...and 63 more locations
Time frame: Week 2 up to Week 18
Mean Time on Pregabalin Monotherapy
Time frame: Week 2 to Week 20
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)
Time frame: Day 1 up to Day 140
Pregabalin Population Pharmacokinetics (PK)
Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.
Time frame: Baseline up to 20 weeks
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.
Time frame: Day 126