A Randomized, Placebo-controlled, Tourette Syndrome Study.
Condition: Tourette Syndrome
MeSH terms: Tourette Syndrome; Syndrome
Intervention: Topiramate (drug); placebo/sugar pill
Intervention description: Topiramate 25 mg titrated to 200 mg; placebo
Intervention MeSH terms: Topiramate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 29.0
Sex: All
Minimum age: 7 Years
Maximum age: 65 Years
Healthy volunteers: No

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.
    

Eligibility 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