|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.
|A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER TRIAL OF PREGABALIN AS ADJUNCTIVE THERAPY IN PEDIATRIC AND ADULT SUBJECTS WITH PRIMARY GENERALIZED TONIC-CLONIC SEIZURES - PROTOCOL A0081105
|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.
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
|Generalized Tonic Clonic Seizures
- Drug: Pregabalin Dose Level 1
Pregabalin, 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.
Other Name: Lyrica Dose Level 1
- Drug: Pregabalin Dose Level 2
Pregabalin, 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.
Other Name: Lyrica Dose Level 2
- Drug: Placebo
Placebo, either liquid or capsule, dosed twice daily beginning at Randomization to End of Study/Early Termination.
- Experimental: Study Drug Level 1
Intervention: Drug: Pregabalin Dose Level 1
- Experimental: Study Drug Level 2
Intervention: Drug: Pregabalin Dose Level 2
- Placebo Comparator: Placebo
Intervention: Drug: Placebo
|February 20, 2019
|February 20, 2019 (Final data collection date for primary outcome measure)
- 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
- 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.
|Sexes Eligible for Study:||All|
|5 Years to 65 Years (Child, Adult, Older Adult)
|Contact information is only displayed when the study is recruiting subjects|
|Austria, Belarus, Bosnia and Herzegovina, Bulgaria, China, Croatia, Denmark, France, Greece, Hungary, India, Korea, Republic of, Lebanon, Malaysia, Montenegro, Philippines, Poland, Romania, Russian Federation, Serbia, Slovakia, Spain, Turkey, Ukraine, United Kingdom, United States
|Argentina, Belgium, Estonia, Germany, Israel, Lithuania, Netherlands, Singapore
2010-023263-18 ( EudraCT Number )
|Studies a U.S. FDA-regulated Drug Product: ||Yes|
|Studies a U.S. FDA-regulated Device Product: ||No|
|Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
|Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
|Study Director:||Pfizer CT.gov Call Center||Pfizer|