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An Open-label Study to Determine the Efficacy and Safety of Topiramate in the Treatment of Tourette Syndrome.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00206336
First Posted: September 21, 2005
Last Update Posted: November 6, 2017
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.
Collaborator:
Ortho-McNeil Janssen Scientific Affairs, LLC
Information provided by (Responsible Party):
Joseph Jankovic, Baylor College of Medicine
Results First Submitted: February 17, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Tourette Syndrome
Intervention: Drug: Topiramate (drug)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Topiramate

Topiramate open label

Topiramate (drug): Topiramate 25 mg to 200 mg


Participant Flow:   Overall Study
    Topiramate
STARTED   20 
COMPLETED   20 
NOT COMPLETED   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Topiramate

Topiramate open label

Topiramate (drug): Topiramate 25 mg to 200 mg


Baseline Measures
   Topiramate 
Overall Participants Analyzed 
[Units: Participants]
 20 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      20 100.0% 
Between 18 and 65 years      0   0.0% 
>=65 years      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 16.5  (9.89) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      2  10.0% 
Male      18  90.0% 
Region of Enrollment 
[Units: Participants]
 
United States   20 


  Outcome Measures

1.  Primary:   Change in TTS   [ Time Frame: baseline to Day 70 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Because of the small sample size and open label design we decided not to pursue publication of the extension study.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Joseph Jankovic
Organization: Baylor College of Medicine
phone: 713-798-6556
e-mail: josephj@bcm.edu


Publications:

Responsible Party: Joseph Jankovic, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00206336     History of Changes
Other Study ID Numbers: CAPSS-286
First Submitted: September 13, 2005
First Posted: September 21, 2005
Results First Submitted: February 17, 2016
Results First Posted: November 6, 2017
Last Update Posted: November 6, 2017