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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. Identifier: NCT00206323
Recruitment Status : Completed
First Posted : September 21, 2005
Results First Posted : November 6, 2017
Last Update Posted : February 12, 2020
Ortho-McNeil Janssen Scientific Affairs, LLC
Information provided by (Responsible Party):
Joseph Jankovic, Baylor College of Medicine

Brief Summary:
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 or disease Intervention/treatment Phase
Tourette Syndrome Drug: Topiramate (drug) Drug: placebo/sugar pill Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Topiramate

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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

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 identifier (NCT number): NCT00206323

Sponsors and Collaborators
Baylor College of Medicine
Ortho-McNeil Janssen Scientific Affairs, LLC
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Principal Investigator: Joseph Jankovic, MD Baylor College of Medicine
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Responsible Party: Joseph Jankovic, Principal Investigator, Baylor College of Medicine Identifier: NCT00206323    
Other Study ID Numbers: H-13552
First Posted: September 21, 2005    Key Record Dates
Results First Posted: November 6, 2017
Last Update Posted: February 12, 2020
Last Verified: January 2020
Additional relevant MeSH terms:
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Tourette Syndrome
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
Hypoglycemic Agents
Physiological Effects of Drugs