A Safety, Efficacy and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric and Adult Subjects With Primary Generalized Tonic-Clonic (i.e., Grand Mal) Seizures.

Phase 3

Completed

Interventions: Drug: Pregabalin Dose Level 1
Drug: Pregabalin Dose Level 2
Drug: Placebo

Brief Summary: The study is designed to evaluate the safety, tolerability and efficacy of two doses of pregabalin as add-on treatment in pediatric and adult subjects with Primary Generalized Tonic-Clonic (PGTC) seizures as compared to placebo. It is hypothesized that both doses of pregabalin will demonstrated superior efficacy when compared to placebo by reducing PGTC seizure frequency and that pregabalin will be safe and well tolerated.

Recruitment & Eligibility

Inclusion Criteria

Seizures classified as Primary Generalized Tonic Clonic Seizures
Must have at least 1 PGTC seizure in the 8 weeks prior to screening
Must have a minimum of 3 PGTC seizures during the 8-week baseline phase and at least 1 PGTC in each 4-week period of the baseline phase
Currently receiving adequate and stable dosage of 1 to 3 anti-epileptic treatments (stable within 28 days of screening)
Signed informed consent and assent if a minor
Ability to comply with daily seizure and dosing diary requirements and all study procedures

Exclusion Criteria

A current diagnosis of febrile seizures, or seizures related to an ongoing acute medical illness
Focal seizures (simple partial, complex partial, or partial becoming secondarily generalized)
Status Epilepticus within 1 year prior to screening
Lennox-Gastaut syndrome, infantile spasms, Benign Epilepsy with Centrotemporal Spikes (BECTS) and Dravet syndrome
Seizures related to drugs, alcohol, or acute medical illness
Any change in anti-epileptic treatment regimen (type of medication or dose; VNS alteration) within 28 days of the screening visit or during the baseline phase
Progressive or potentially progressive structural CNS lesion or a progressive encephalopathy.
Progressive inborn errors of metabolism.

Arm && Interventions

Primary Outcome Measures

Name	Time	Method
Log-transformed (Log) 28-day Seizure Rate for All Primary Generalized Tonic-Clonic (PGTC) Seizures During 12-Week Double-Blind Treatment Phase	Day 1 up to Week 12	All PGTC seizures experienced during treatment phase were recorded by the participants or their parents/legal guardian in a daily seizure diary. 28-day seizure rate for all PGTC seizures= (\[number of seizures in the double blind treatment phase\] divided by \[number of days in double blind treatment phase minus {-} number of missing diary days in treatment phase\])\*28. For log-transformation, the quantity 1 was added to the 28-day seizure rate for all participants to account for any possible "0" seizure incidence. This resulted in final calculation as: log transformed (28-day seizure rate +1).

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With at Least 50 Percent (%) or Greater Reduction From Baseline in 28-day Primary Generalized Tonic-clonic (PGTC) Seizure Rate During the 12-Week Double-blind Treatment Phase	Day 1 up to Week 12	Percentage of participants with 50% or greater reduction from baseline in 28-day seizure rate during the 12 week double blind treatment phase were reported. 28-day seizure rate for all PGTC seizures= (\[number of seizures in the double blind treatment phase\] divided by \[number of days in double blind treatment phase minus {-} number of missing diary days in treatment phase\])\*28.

Locations (122): Axcess Medical Research
🇺🇸
Loxahatchee Groves, Florida, United States
Pediatric Epilepsy Center of Central Florida
🇺🇸
Orlando, Florida, United States
Pediatric Neurology, PA
🇺🇸
Orlando, Florida, United States
Medsol Clinical Research Center
🇺🇸
Port Charlotte, Florida, United States
Hawaii Pacific Neuroscience
🇺🇸
Honolulu, Hawaii, United States
Alexian Brothers Center for Psychiatric Research
🇺🇸
Hoffman Estates, Illinois, United States
Chinmay K. Patel, D.O.
🇺🇸
Hoffman Estates, Illinois, United States
St. Alexius Medical Center
🇺🇸
Hoffman Estates, Illinois, United States
Ohio Clinical Research Partners, LLC
🇺🇸
Canton, Ohio, United States
Road Runner Research, Ltd
🇺🇸
San Antonio, Texas, United States
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Axcess Medical Research
🇺🇸Loxahatchee Groves, Florida, United States