CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 29 enrolled
Drug / intervention
Topiramate (drug) +1 moredrug
Likely dose
Topiramate 25 mg titrated to 200 mgAI-extracted
Key inclusion· 8
  • ✓Diagnosis of Tourette Syndrome for at least 3 months
  • ✓Minimum Tic rating scale ≥19 at screening visits (Day -10 through -7 and Day 1)
  • ✓Severity rating scale score ≥4 (moderately ill) at screening visits
  • ✓Age 7–65 years, inclusive
Key exclusion· 13
  • ✕Prior non-response to topiramate for Tourette Syndrome after adequate trial
  • ✕Prior topiramate discontinuation due to adverse event or known hypersensitivity
  • ✕Substance dependence or abuse (except nicotine or caffeine) within past 3 months
  • ✕Significant and unstable major psychiatric disorder requiring treatment

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00206323
NCT00206323Phase 3Completed
CompareCT.gov

A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Determine the Safety and Efficacy of Topiramate in the Treatment of Tourette Syndrome (CAPSS-176)

Baylor College of Medicine·interventional·Posted Sep 21, 2005·Updated Feb 12, 2020

In Brief

A Phase 3 clinical trial evaluating Topiramate (drug) and placebo/sugar pill for Tourette Syndrome. Completed, enrolled 29 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
First PostedSep 21, 2005
Enrollment StartSep 1, 2004
Primary CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 20.8 years ago

Interventions

Topiramate (drug)drug

Topiramate 25 mg titrated to 200 mg

placebo/sugar pilldrug

placebo