A Study of the Efficacy and Safety of Topiramate as an add-on Therapy in the Treatment of Epilepsy Patients With Lennox-Gastaut Syndrome

Phase 3 Completed 100 enrolled Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to evaluate the effectiveness and safety of topiramate as add-on therapy in the treatment of epilepsy patients with Lennox-Gastaut syndrome, a severe form of epilepsy in which there are mixed types of seizures.

Timeline

Start: 1993-08
Primary completion: —
Completion: 2001-02

Outcome

Met primary endpoint

paper 14.8% for the topiramate group and -5.1% (an increase) for the placebo group (p = 0.041). PMID 10371538 ↗

Publications

Results Sachdeo RC, Glauser TA, Ritter F, Reife R, Lim P, Pledger G. A double-blind, randomized trial of topiramate in Lennox-Gastaut syndrome. Topiramate YL Study Group. Neurology. 1999 Jun 10;52(9):1882-7. doi: 10.1212/wnl.52.9.1882.
Brigo F, Jones K, Eltze C, Matricardi S. Anti-seizure medications for Lennox-Gastaut syndrome. Cochrane Database Syst Rev. 2021 Apr 7;4(4):CD003277. doi: 10.1002/14651858.CD003277.pub4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Topiramate	Small molecule	6 mg/kg	Oral