A Study of the Efficacy and Safety of Topiramate as add-on Therapy in the Treatment of Epilepsy Patients With Difficult to Treat, Partial-onset Seizures.

Phase 2 Completed 47 enrolled Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of the study is to evaluate the efficacy and safety of topiramate in epilepsy patients with difficult to treat, partial-onset seizures who are taking one or two standard antiepileptic drugs.

Timeline

Start: 1989-10
Primary completion: —
Completion: 1993-05

Outcome

Missed primary endpoint

paper Median percent reduction from baseline in monthly seizure frequency during the double-blind phase was not significantly greater in the topiramate group than in the placebo group (41% vs. 1%; P = 0.065). PMID 8956919 ↗

Publications

Results Sharief M, Viteri C, Ben-Menachem E, Weber M, Reife R, Pledger G, Karim R. Double-blind, placebo-controlled study of topiramate in patients with refractory partial epilepsy. Epilepsy Res. 1996 Nov;25(3):217-24. doi: 10.1016/s0920-1211(96)00029-0.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Topiramate	Small molecule	400 mg	Oral