drugset
drugset / Trial / NCT01627860

First Add-on vs. Mono-therapy Study of Topiramate in Neuro-Surgical Patients

NCT01627860 ↗

Phase 4 Completed 55 enrolled Johnson & Johnson Taiwan Ltd
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to examine seizure control and tolerability of Topiramate after either transitioning from previous antiepileptic drug (AED) or adding on to previous AED.

Timeline

Start
2010-02
Primary completion
2011-01
Completion
2011-01

Outcome

Missed primary endpoint

registry p = 0.0759; Difference in Seizure free rate 23.57 (95% CI -4.21 to 49.00) NCT01627860 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Topiramate Small molecule 200 mg Oral

Indications

epilepsy