At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 20 enrolled
Drug / intervention
Topiramate (drug)drug
Likely dose
Topiramate 25 mg to 200 mgAI-extracted
Key inclusion· 4
- ✓Must have completed the double-blind phase or discontinued after minimum 6 weeks due to lack of efficacy (CGI improvement >6)
- ✓Must meet all inclusion criteria from CAPSS-176 or CAPSS-198
- ✓Must continue current tic treatment and comorbid/ADHD treatment at established dose
- ✓Able to read/comprehend written instructions and complete all study assessments
Key exclusion· 2
- ✕SGOT and/or SGPT >2 times upper limit of normal at last visit in prior trial
- ✕Must meet all exclusion criteria from CAPSS-176 or CAPSS-198
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-label Study to Determine the Efficacy and Safety of Topiramate in the Treatment of Tourette Syndrome (CAPSS-286)
In Brief
A Phase 3 clinical trial evaluating Topiramate (drug) for Tourette Syndrome. Completed, enrolled 20 participants.
Detailed Summary
Previous studies using topiramate in Tourette subjects have shown that with the use of this medication subjects report that their tics get better. The purpose of this study is to study if topiramate improves the symptoms of Tourette syndrome, such as motor tics, or other associated symptoms such as attention or obsessive-compulsive problems.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTourette Syndrome
Countries--
CollaboratorsOrtho-McNeil Janssen Scientific Affairs, LLC
Timeline
Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 2004
First PostedSep 2005
Primary CompletionDec 2008
TodayJul 2026
First PostedSep 21, 2005
Enrollment StartOct 1, 2004
Primary CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 20.8 years ago
Interventions
Topiramate (drug)drug
Topiramate 25 mg to 200 mg