A Study of the Efficacy and Safety of Topiramate in the Treatment of Patients With Epilepsy.

Phase 2 Completed 60 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 an add-on therapy in patients with uncontrolled partial onset seizures who are taking one or two standard antiepileptic drugs.

Timeline

Start: 1989-12
Primary completion: —
Completion: 1993-07

Outcome

Met primary endpoint

paper TPM was significantly superior to placebo, as indicated by all efficacy assessments: greater median percent reduction from baseline in the average monthly seizure rate PMID 8764816 ↗

Publications

Results Tassinari CA, Michelucci R, Chauvel P, Chodkiewicz J, Shorvon S, Henriksen O, Dam M, Reife R, Pledger G, Karim R. Double-blind, placebo-controlled trial of topiramate (600 mg daily) for the treatment of refractory partial epilepsy. Epilepsia. 1996 Aug;37(8):763-8. doi: 10.1111/j.1528-1157.1996.tb00649.x.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Topiramate	Small molecule	300 mg	Oral