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

This study is currently recruiting participants.

Verified by Baylor College of Medicine, September 2005

Sponsors and Collaborators:	Baylor College of Medicine Ortho-McNeil Neurologics, Inc.
Information provided by:	Baylor College of Medicine
ClinicalTrials.gov Identifier:	NCT00206336

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 III

Genetics Home Reference related topics: familial encephalopathy with neuroserpin inclusion bodies familial paroxysmal nonkinesigenic dyskinesia Tourette syndrome

MedlinePlus related topics: Tourette Syndrome

Drug Information available for: Topiramate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open-Label Study to Determine the Efficacy and Safety of Topiramate in the Treatment of Tourette Syndrome

Further study details as provided by Baylor College of Medicine:

Study Start Date:

October 2004

Show Detailed Description

Eligibility

Ages Eligible for Study:	7 Years to 65 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00206336

Contacts

Contact: Cynthia L Studenko, BBA	713-798-9014	studenko@bcm.tmc.edu
Contact: Christine Hunter, RN	713-798-3951	chunter@bcm.tmc.edu

Locations

United States, Texas
Baylor College of Medicine - Neurology	Recruiting
Houston, Texas, United States, 77030
Contact: Cynthia L Studenko, BBA 713-798-9014 studenko@bcm.tmc.edu
Principal Investigator: Joseph Jankovic, MD

Sponsors and Collaborators

Baylor College of Medicine

Ortho-McNeil Neurologics, Inc.

Investigators

Principal Investigator:

Joseph Jankovic, MD

Baylor College of Medicine

More Information

Study ID Numbers:	CAPSS-286
Study First Received:	September 13, 2005
Last Updated:	September 13, 2005
ClinicalTrials.gov Identifier:	NCT00206336
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Ganglion Cysts
Basal Ganglia Diseases
Central Nervous System Diseases
Tourette Syndrome
Tic Disorders
Brain Diseases
Neurodegenerative Diseases
Tics

Heredodegenerative Disorders, Nervous System
Genetic Diseases, Inborn
Movement Disorders
Mental Disorders
Mental Disorders Diagnosed in Childhood
Topiramate
Gilles de la Tourette's syndrome

Additional relevant MeSH terms:

Anti-Obesity Agents
Pathologic Processes
Disease
Therapeutic Uses
Syndrome
Physiological Effects of Drugs

Nervous System Diseases
Protective Agents
Neuroprotective Agents
Central Nervous System Agents
Pharmacologic Actions
Anticonvulsants

ClinicalTrials.gov processed this record on January 16, 2009