CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 99 enrolled
Drug / intervention
TRI476 +2 moredrug
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.

Search/NCT00975715
NCT00975715Phase 3Completed
CompareCT.gov

A Multicentre, Randomized, Double-blind, Placebo Controlled, Parallel-group Study in Children With Inadequately Controlled Partial Onset Seizures to Investigate Efficacy, Safety and Tolerability of TRI476 (Oxcarbazepine) as Adjunctive Therapy

Novartis Pharmaceuticals·interventional·Posted Sep 11, 2009·Updated Jul 16, 2014

In Brief

A Phase 3 clinical trial evaluating TRI476, Placebo to TRI476, and 1 other intervention for Partial Onset Seizures. Completed, enrolled 99 participants across 25 sites.

Detailed Summary

This study is designed to provide short term efficacy and safety data of TRI476 in children with inadequately-controlled partial seizures. Patients will be randomized into either drug treatment or placebo group at 1:1 ratio, and receive their respective treatment for 8 weeks. The purpose of study is to confirm that TRI476 as adjunctive therapy is effective and safe.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPartial Onset Seizures
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 11, 2009
Enrollment StartSep 1, 2009
Primary CompletionOct 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 16.8 years ago

Interventions

TRI476drug

TRI476 oral suspension doses, based on body weight twice daily

Placebo to TRI476drug

Placebo oral suspension, taken twice daily

Benzodiazepinesdrug

Benzodiazepines could be used as needed as rescue medication during the duration of the study.