At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 139 enrolled
Drug / intervention
Topiramatedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Open Flexible Dose Optimisation Trial Assessing Tolerability and Efficacy of Topiramate Monotherapy in Recently Diagnosed Patients With Epilepsy Who Are Treatment Naive or Have Failed One Anti-Epileptic Drug Treatment in Monotherapy
In Brief
A Phase 4 clinical trial evaluating Topiramate for Epilepsy. Completed, enrolled 139 participants across 2 sites.
Detailed Summary
The purpose of this dose optimization study is to assess tolerability and efficacy of topiramate monotherapy in recently diagnosed patients with epilepsy who are treatment naive or have failed one anti-epileptic drug (AED) treatment in monotherapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy
CountriesVietnam
Collaborators--
Timeline
Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2008
Primary CompletionJan 2010
First PostedSep 2012
TodayJul 2026
First PostedSep 21, 2012
Enrollment StartMay 2, 2008
Primary CompletionJan 19, 2010
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 13.8 years ago
Interventions
Topiramatedrug
The patients will receive topiramate tablet twice daily orally up to 16 weeks.