Generalized Tonic Clonic Seizures | 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.
Generalized Tonic Clonic Seizures research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Generalized Tonic Clonic Seizures
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Pregabalin Dose Level 1Pregabalin, either liquid or capsule, dosed twice daily, escalated up to a maximum of 300 mg/day beginning at Randomization to Taper Phase, then tapered down to a maximum dose of 150 mg/day during 1 week Taper Phase to End of Study/Early Termination.
Drug:Pregabalin Dose Level 2Pregabalin, either liquid or capsule, dosed twice daily, escalated up to a maximum of 600 mg/day beginning at Randomization to Taper Phase, then tapered down to a maximum of 150 mg/day during 1 week Taper Phase to End of Study/Early Termination.
Drug:PlaceboPlacebo, either liquid or capsule, dosed twice daily beginning at Randomization to End of Study/Early Termination.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Study Drug Level 1
Study Drug Level 2
Start Date: April 3, 2013
Completed Date: February 22, 2019
Phase: Phase 3
Primary Outcome: Percent reduction of 28 day seizure rate for all PGTC seizures relative to placebo during the double blind assessment phase.
Secondary Outcome: Responder rate, defined as the proportion of subjects who had at least a 50% reduction in 28 day PGTC seizure.
Study sponsors, principal investigator, and references
Principal Investigator: Pfizer CT.gov Call Center
Lead Sponsor: Pfizer