A Study of the Effectiveness and Safety of Topiramate Monotherapy in Patients With Recently Diagnosed Partial-Onset Seizure

Phase 3 Completed 451 enrolled Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

RandomizedParallel-groupDouble-blindTreatment

Summary

The purposes of this study are (1) to compare the effectiveness of two doses of topiramate and (2) to assess the safety of topiramate alone in the treatment of pediatric and adult patients with recently diagnosed epilepsy characterized by partial-onset seizures.

Timeline

Start: 1995-11
Primary completion: —
Completion: 2002-08

Outcome

Missed primary endpoint

paper Although the primary efficacy analysis was negative PMID 12552030 ↗

Publications

Results Gilliam FG, Veloso F, Bomhof MA, Gazda SK, Biton V, Ter Bruggen JP, Neto W, Bailey C, Pledger G, Wu SC. A dose-comparison trial of topiramate as monotherapy in recently diagnosed partial epilepsy. Neurology. 2003 Jan 28;60(2):196-202. doi: 10.1212/01.wnl.0000048200.12663.bc.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Topiramate	Small molecule	24 mg/kg	Oral
Subject	Topiramate	Small molecule	25 mg	Oral
Subject	Topiramate	Small molecule	50 mg	Oral
Subject	Topiramate	Small molecule	200 mg	Oral
Subject	Topiramate	Small molecule	500 mg	Oral
Subject	Topiramate	Small molecule	1600 mg	Oral