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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
  Purpose
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.

Condition Intervention Phase
Tourette Syndrome Drug: Topiramate (drug) Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Study to Determine the Efficacy and Safety of Topiramate in the Treatment of Tourette Syndrome (CAPSS-286)

Resource links provided by NLM:


Further study details as provided by Joseph Jankovic, Baylor College of Medicine:

Primary Outcome Measures:
  • Change in TTS [ Time Frame: baseline to 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 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).


Enrollment: 20
Study Start Date: October 2004
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: topiramate
Topiramate open label
Drug: Topiramate (drug)
Topiramate 25 mg to 200 mg
Other Name: Topamax

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must continue to meet the specific inclusion criteria outlined in either CAPSS-176 or CAPSS-198 to enroll in this protocol.
  • Subjects must have completed the Double-Blind Phase or discontinued the Double-Blind Phase after a minimum of 6 weeks due to lack of efficacy (defined by a CGI improvement score of >6 [much worse or very much worse]) in either CAPSS-176 or CAPSS-198.
  • Subjects or their parents/guardians, must be able to read and comprehend written instructions and willing to complete all scales and assessments required by this protocol.
  • After full explanation of the study, subjects, or their parent/legally authorized representatives, must demonstrate their willingness to participate by signing an informed consent form. If applicable, pediatric subjects capable of giving assent must sign the assent form.
  • Subjects must continue their current treatment for tics, treatment of comorbid symptoms or treatment of A-D/HD at the dose level established prior to entry in the Double-Blind Phase of CAPSS-176 or CAPSS-198.

Exclusion Criteria:

  • Subjects must continue to meet the specific exclusion criteria outlined in either CAPSS-176 or CAPSS-198 to enroll in this protocol.
  • Subjects who have SGOT and/or SGPT levels greater than 2 times the upper limit of the normal range from the last visit in either CAPSS-176 or CAPSS-198 will not be permitted to enroll in the current study.
  Contacts and Locations
Information from the National Library of Medicine

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): NCT00206336


Sponsors and Collaborators
Baylor College of Medicine
Ortho-McNeil Janssen Scientific Affairs, LLC
Investigators
Principal Investigator: Joseph Jankovic, MD Baylor College of Medicine
  More Information

Publications:
Responsible Party: Joseph Jankovic, Principal Investigator, 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
Last Verified: October 2017

Additional relevant MeSH terms:
Syndrome
Tourette Syndrome
Disease
Pathologic Processes
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tic Disorders
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Neurodevelopmental Disorders
Mental Disorders
Topiramate
Anticonvulsants
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents