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A Randomized, Placebo-Controlled, Tourette Syndrome Study.
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: NCT00206323
  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, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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.

Further study details as provided by Baylor College of Medicine:

Estimated Enrollment: 16
Study Start Date: September 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 have a diagnosis of Tourette Syndrome for at least 3 months.
  • Subjects must have a minimum Tic rating scale of > or equal to 19 (current symptoms excluding impairment) at Visit 1 (Day -10 through Day -7) and Visit 2 (Day ).
  • Subjects must have a rating scale severity score of > or equal to 4 (moderately ill) at Visit 1 (Day -10 through Day -7) and Visit 2 (Day 1).
  • Subjects must be between 7 and 65 years of age, inclusive.
  • Subjects must be >25 kg (55 lbs).
  • Subjects must be able to take oral medication in tablet form without crushing or otherwise altering the tablet, adhere to medication regimens and be willing to return for regular visits.
  • Subjects must have observed the designated washout periods for prohibited medications outlined under the Concomitant Therapy section of this protocol.
  • Subjects must have a negative urine drug screening at Visit 1 (Day -7).
  • Subjects must be in generally good health as confirmed by medical history, baseline psychiatric history and physical examination, including vital signs.
  • Subjects must: a) be premenarchal, postmenopausal for at least one year, or b) have had a hysterectomy or tubal ligation or otherwise be incapable of pregnancy, or c) have practiced one of the following methods of contraception for at least one month prior to study entry: hormonal contraceptives, spermicide and barrier, intrauterine device, spousal/partner sterility or d) be practicing abstinence and agree to continue abstinence or to use an acceptable method of contraception (as listed above) should sexual activity commence. If (c) or (d), subjects must have a negative urine pregnancy test up to one week prior to Visit 2 (Day 1).
  • Subjects, or their parents/guardians, must be able to read and comprehend written instructions and willing to complete all scales and inventories required by this protocol.

Exclusion Criteria:

  • Subjects who have a diagnosis of substance dependence or abuse (with the exception of nicotine or caffeine dependence) within the past 3 months.
  • Subjects with a significant and unstable major psychiatric disorder requiring treatment.
  • Subjects with mental retardation.
  • Subjects with progressive or degenerative neurological disorders or a structural disorder of the brain from birth, trauma or past infection.
  • Subjects taking more than one agent for the treatment of tics, more than one agent for the treatment of comorbid symptoms or more than one agent for the treatment of ADHD and/or the dose of the current treatment has not been stable for a minimum of 6 weeks.
  • Subjects who are pregnant or lactating.
  • Subjects with prior non-response to topiramate for the treatment of Tourette Syndrome following an adequate trial.
  • Subjects with a history of nephrolithiasis.
  • Subjects with an estimated creatinine clearance of <60 mL/min.
  • Subjects who have Liver function levels greater than 2 times the upper limit of the normal range at Visit 1.
  • Subjects who have active liver disease.
  • Subjects who have previously been treated with topiramate and discontinued treatment due to an adverse event or subjects with a known hypersensitivity to topiramate.
  • Subjects known to have clinically significant medical conditions, including, but not limited to: a) any unstable disease or condition, including cardiovascular, renal, gastrointestinal, pulmonary, metabolic, endocrine or other systemic disease that could compromise the function of those body systems that could result in altered absorption, excess accumulation or impaired metabolism or excretion of topiramate or interfere with their participation in the study; b) malignancy or history of malignancy (excluding basal cell carcinoma) within the past 5 years; and c) subjects with a history of attempted suicide or suicidal tendencies or judged clinically to be at serious suicidal risk
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00206323

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-176
Study First Received: September 13, 2005
Last Updated: September 13, 2005
ClinicalTrials.gov Identifier: NCT00206323  
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