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.

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.

Timeline

Start

2013-04-03

Primary completion

2019-02-20

Completion

2019-02-20

Outcome

Missed primary endpoint

registry analysis (superiority test); Pregabalin 5 mg/kg/Day or 7 mg/kg/Day or 300 mg/Day vs Placebo; p = 0.8121 NCT01747915 ↗

registry analysis (superiority test); Pregabalin 10 mg/kg/Day or 14 mg/kg/Day or 600 mg/Day vs Placebo; p = 0.8889 NCT01747915 ↗

paper A nonsignificant change in log-transformed mean 28-day seizure rate was seen with pregabalin 10 mg/kg/day vs placebo PMID 34033265 ↗

Publications

• Driscoll J, Almas M, Gregorian G, Kyrychenko A, Makedonska I, Liu J, Patrick J, Scavone JM, Antinew J; 1105 Study Group. Pregabalin as adjunctive therapy in adult and pediatric patients with generalized tonic-clonic seizures: A randomized, placebo-controlled trial. Epilepsia Open. 2021 Jun;6(2):381-393. doi: 10.1002/epi4.12492. Epub 2021 May 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pregabalin	Small molecule	5 mg/kg	—
Subject	Pregabalin	Small molecule	10 mg/kg	—

Indications