A Randomized, Placebo-Controlled, Tourette Syndrome Study.

This study has been completed.
Sponsor:
Collaborator:
Ortho-McNeil Janssen Scientific Affairs, LLC
Information provided by:
Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00206323
First received: September 13, 2005
Last updated: April 30, 2009
Last verified: April 2009
  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: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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.

Resource links provided by NLM:


Further study details as provided by Baylor College of Medicine:

Estimated Enrollment: 16
Study Start Date: September 2004
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
  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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00206323

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

No publications provided by Baylor College of Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Joseph Jankovic, mD, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00206323     History of Changes
Other Study ID Numbers: CAPSS-176
Study First Received: September 13, 2005
Last Updated: April 30, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Tourette Syndrome
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
Mental Disorders Diagnosed in Childhood
Mental Disorders
Topiramate
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents

ClinicalTrials.gov processed this record on July 23, 2014