Once-A-Day Pregabalin For Partial Seizures

Summary

Approximately 30% percent of subjects with partial seizures are refractory to treatment with single or combination antiepileptic drugs. The present study will compare the efficacy of two different dosages of pregabalin CR dosed once daily as compared to placebo, when used as adjunctive therapy in subjects requiring adjunctive therapy for partial onset epilepsy, using a randomized, parallel group design.

Timeline

Start

2011-02-17

Primary completion

2012-07-31

Completion

2012-08-01

Outcome

Missed primary endpoint

registry analysis (superiority test); Pregabalin 165 mg vs Placebo; p = 0.9076; Mean Difference -0.99 (95% CI -16.28 to 17.11); NCT01262677 ↗

registry analysis (superiority test); Pregabalin 330 mg vs Placebo; p = 0.0907; Mean Difference -13.05 (95% CI -26.07 to 2.25); NCT01262677 ↗

paper and was not statistically significant (p = 0.091, 0.908). PMID 24962242 ↗

Publications

• French J, Brandt C, Friedman D, Biton V, Knapp L, Pitman V, Chew M, Dubrava S, Posner HB. Adjunctive use of controlled-release pregabalin in adults with treatment-resistant partial seizures: a double-blind, randomized, placebo-controlled trial. Epilepsia. 2014 Aug;55(8):1220-8. doi: 10.1111/epi.12690. Epub 2014 Jun 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pregabalin	Small molecule	165 mg	—
Subject	Pregabalin	Small molecule	330 mg	—

Indications