A Randomized, Placebo-controlled, Tourette Syndrome Study.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00206323|
Recruitment Status : Completed
First Posted : September 21, 2005
Results First Posted : November 6, 2017
Last Update Posted : February 12, 2020
|Condition or disease||Intervention/treatment||Phase|
|Tourette Syndrome||Drug: Topiramate (drug) Drug: placebo/sugar pill||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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)|
|Study Start Date :||September 2004|
|Actual Primary Completion Date :||December 2008|
|Actual Study Completion Date :||December 2008|
Placebo Comparator: placebo/sugar pill
Placebo or sugar pill
Drug: placebo/sugar pill
Other Name: placebo
Active Comparator: Topiramate
Topiramate 25 mg to 200 mg
Drug: Topiramate (drug)
Topiramate 25 mg titrated to 200 mg
Other Name: Topamax
- Change From Baseline in Total Tic Score at Day 70 [ Time Frame: baseline and Day 70 ]
A component of the Yale Global Tic Severity Scale (YGTSS), the change from baseline in Total Tic Score (TTS) at visit 5 (day 70) is the pre-defined primary endpoint.
The Total Tic Score (TTS) is a summation of the Total Motor Tic and Total Phonic Tic Scores. The Overall Impairment Rating is rated on a 50-point scale anchored by 0 (No impairment) and 50 (Severe impairment).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00206323
|Principal Investigator:||Joseph Jankovic, MD||Baylor College of Medicine|