CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 366 enrolled
Drug / intervention
Placebo +2 moredrug
Likely dose
2400mg SPN-804from 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.

Search/NCT00772603
NCT00772603Phase 3Completed
CompareCT.gov

Phase III Study to Evaluate the Efficacy and Safety of OXC XR as Adjunctive Therapy in Subjects With Refractory Partial Seizures

Supernus Pharmaceuticals, Inc.·interventional·Posted Oct 15, 2008·Updated Feb 11, 2014

In Brief

A Phase 3 clinical trial evaluating Placebo, 2400mg SPN-804, and 1 other intervention for Epilepsies, Partial. Completed, enrolled 366 participants across 71 sites in 8 countries.

Detailed Summary

Evaluation of the safety and efficacy of Oxcarbazepine XR as adjunctive treatment for adults with partial onset seizures

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsies, Partial
CountriesBulgaria, Canada, Croatia, Mexico, Poland, Romania, Russia, United States
CollaboratorsParexel

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 15, 2008
Enrollment StartNov 1, 2008
Primary CompletionApr 1, 2010
Study CompletionNov 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 17.7 years ago

Interventions

Placebodrug

Non-active tablet identical to study drug tablets

2400mg SPN-804drug

tablets containing 600mg OXC XR, identical to non-active tablets

1200mg SPN-804drug

two active tablets and two non-active tablets, all identical