A Randomized, Placebo-controlled, Tourette Syndrome Study.
Condition: Tourette Syndrome
MeSH terms: Tourette Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      This study consists of three phases: Screening/Washout Phase, Double-Blind Phase and Taper
      Phase.

      SCREENING/WASHOUT PHASE: Your study doctor or his staff will review with you any medications
      that you are currently taking and may instruct you, if appropriate, to discontinue taking
      certain medications. Your study doctor or his staff will explain how long you need to stop
      taking each drug before you can start the study. Depending on the type of medications you may
      be taking, the Screening/Washout Visit (Visit 1 of the study) may have to be completed in two
      visits. The screening/washout phase may take up to 90 days. If you agree to participate, the
      study doctor or his staff will carry out tests to see if you are eligible for this study. At
      the Screening/Washout Visit, you will have a medical and psychiatric history review
      (including medications you have taken for treating Tourette Syndrome) and a physical
      examination (including sitting blood pressure, pulse, temperature, weight and height). A
      blood sample will be taken (approximately 2-3 teaspoons) and tested to rule out any
      abnormalities. You will be asked to give a urine sample that will be tested for drug use and,
      if you are a female that is capable of having a child, to ensure that you are not pregnant at
      the time of study entry. The pregnancy test must be negative for you to continue in the
      study. Additionally, you may not currently be breastfeeding to continue in the study. You
      will undergo a medical and psychiatric evaluation. You will be asked to answer questions
      using scales, including one that measures the severity of your symptoms of Tourette Syndrome
      and one that measures your symptoms, if any, of attention deficit hyperactivity disorder
      (A-D/HD).

      TITRATION/MAINTANENCE PHASE: If you continue to qualify for the study after the Visit 1 tests
      have been reviewed by the study doctor or his staff and you have completed the washout phase,
      you will return to your study doctor's office for Visit 2. The length of time between Visit 1
      and Visit 2 will depend on the kind of medications you are taking (and may need to stop
      before entering this study). At Visit 2, you will have your blood pressure, pulse and weight
      measured. You will be asked to answer questions for the same two scales that you completed at
      Visit 1. You are asked to return all medication bottles (even if empty, partially used or
      unused) to each study visit. It is very important for us to be able to check study drug
      compliance.

      You will be asked questions about how you are feeling and if you have started taking any new
      medications or had changes in other medications you may be taking since your last visit.

      If you continue to meet eligibility requirements for the study, you will enter the study. You
      will be assigned by chance to one of two treatment groups. You may receive either topiramate
      or placebo (an inactive substance). This makes the assessment of the study drug much fairer.
      The chances you are receiving the study drug versus placebo are 1 to 1 or equal (50% chance
      that you will receive topiramate and 50% chance that you will receive placebo).

      The study will last approximately 10 weeks. You will begin the study by taking 1 tablet of
      study medication (topiramate 25 mg or placebo) in the evening. This will be Day 1 of the
      study. After one week of this phase of the study, your study medication dose will be
      increased to 2 tablets (topiramate 50 mg or placebo) one tablet in the morning and one in the
      evening. Your study medication dose may continue to be increased until you have reached the
      dose level the study doctor determines to be appropriate for you, or, you are taking a
      maximum dose of 200 mgs per day of study medication (topiramate or placebo). Your study
      doctor may adjust your study medication dose as necessary. Study medication will be provided
      in 25 mg tablets of topiramate or placebo. Medication is provided in child-resistant bottles.
      All bottles should be returned (regardless of whether they are partial, empty or full) at
      each visit. It is important that you follow your study doctor or his staff's instructions on
      when and how to take the study medication. You will be expected to visit your study doctor or
      his staff again on Day 28 (Visit 3), Day 56 (Visit 4) and Day 70 (Visit 5) after beginning
      treatment. At Visit 5 (Day 70), you will be given instructions about reducing your study
      medication gradually for the next week.

      At each visit, you will have your blood pressure, pulse, temperature and weight measured. You
      will be asked how you are feeling and if you have started taking any new medications or had
      changes in other medications you may be taking. At Visits 3 and 5 you will be asked again to
      answer questions for all of the scales that you completed at Visit 2. At Visits 3, 4 and 5,
      the study doctor or his staff will complete the scale that assesses the severity of your
      condition. At Visits 3 and 5, the study doctor or his staff will complete one scale that
      assesses the severity of your Tourette Syndrome symptoms. At Visits 3, 4 and 5 you will have
      a urine pregnancy test performed again if you are a female capable of bearing a child. The
      test must be negative to continue in the study. You will have blood drawn again
      (approximately one teaspoon) at Visits 3 and 5 to make sure that your liver is functioning
      properly and that your electrolytes (blood chemistry measurements) are also within normal
      range. At Visit 5 you will have another physical examination.

      You will be called weekly between Visits 2 and 3 (Days 7, 14 and Day 21 of the study) and
      Visits 3 and 4 (Days 35 and 42 of the study) on the telephone by one of the people working on
      this study. During these phone calls you will be asked how you are feeling, if you have had
      any changes in medications you are taking and how you are doing with the study medication.

      TAPER PHASE: You will visit the study doctor or his staff again on Day 77 (Visit 6) after you
      have completely stopped taking the study medication. You must keep all medication packaging
      and any unused medication, and bring it back to the study doctor or his staff at each visit.
      At this visit, you will have your blood pressure and pulse taken and your weight measured.
      You will be asked again to answer questions for the scale that measures the severity of your
      symptoms of Tourette Syndrome. If you are a female capable of bearing a child, a urine
      pregnancy test will be performed. You will be asked how you are feeling and if you have
      started taking any new medications or had changes in other medications you may be taking.

      Joseph Jankovic, Joohi Jimenez-Shahed and Lawrence Brown J. Neurol. Neurosurg. Psychiatry
      published online 1 Sep 2009; doi:10.1136/jnnp.2009.185348
    

Intervention name(s): Topiramate (drug); placebo/sugar pill
Intervention type(s): Drug; Drug
Intervention description(s): Topiramate 25 mg titrated to 200 mg; placebo
Other intervention name(s): Topamax; placebo
Intervention MeSH terms: Topiramate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment