An Open-label Study to Determine the Efficacy and Safety of Topiramate in the Treatment of Tourette Syndrome.
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: 
      In order to enroll in this study, you must have completed the Double-Blind phase of CAPSS-176
      or discontinued the Double-Blind phase of CAPSS-176 after a minimum of 6 weeks because it has
      been determined that your symptoms of Tourette Syndrome were getting worse. You must also
      continue to meet the specific inclusion and exclusion criteria outlined in CAPSS-176.

      The Titration/Maintenance Period: will last for 10 weeks, as it did during CAPSS-176. During
      the Titration and Maintenance Periods of the study, you will visit the study center 4 times.
      Visit 1 (Day 1) will be the same day as your final visit for CAPSS-176. You will have had a
      physical examination (including sitting blood pressure, pulse and weight), a urine pregnancy
      test if you are a female that is capable of having a child and been given the scale that
      measures the severity of your symptoms of Tourette Syndrome as part of the final visit
      procedures for CAPSS-176. This information will also be included as part of Visit 1.

      During this visit, a blood sample will be taken (approximately 3 teaspoons) and tested to
      rule out any abnormalities and to make sure that your liver is working properly and your
      electrolytes are normal. You will also be asked to answer questions for the scale that
      measures your symptoms, if any, of attention deficit hyperactivity disorder (A-D/HD). If you
      have Bipolar II Disorder, you will be asked to answer questions for one scale that measures
      your symptoms of mania. If you have obsessive-compulsive disorder (OCD), you will be asked to
      answer questions for one scale that measures those symptoms. The study doctor or his staff
      will complete two scales that assess the severity of your condition.

      If you continue to be eligible for the study, you will begin the Titration Period of the
      study by taking 1 tablet of commercial topiramate 25 mg in the evening. This will be Day 1 of
      the study. After one week of this phase of the study, your topiramate dose will be increased
      to 2 tablets of topiramate (50 mg total), one tablet in the morning and one in the evening.
      Your topiramate 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 topiramate. Your study doctor may adjust your topiramate dose as necessary.

      During the study, you will be expected to visit your study doctor or his staff again on Day
      28 (Visit 2), Day 56 (Visit 3) and Day 70 (Visit 4) after beginning treatment. Extra visits
      may be scheduled at the discretion of your study doctor. At each visit, you will have your
      blood pressure, pulse 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. All of the scales that were completed at Visit 1, and the scale that was completed at
      the final visit of CAPSS-176, will be completed again at each visit. You will have a urine
      pregnancy test performed at each visit if you are a female capable of having a child. The
      test must be negative to continue in the study. You will have blood drawn again
      (approximately three teaspoons) at Visits 2 and 4 to make sure that your liver is functioning
      properly and your electrolytes are normal.

      You will be called between Visits 1 and 2 (Day 14 of the study) and Visits 2 and 3 (Day 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 topiramate.

      Commercial topiramate will be provided in 25 mg tablets.Study 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 topiramate. At Visit 4 (Day 70), you will be
      given instructions about reducing your topiramate dose gradually for the next week. You will
      visit the study doctor or his staff again on Day 77 (Visit 5) after you have completely
      stopped taking the topiramate.
    

Intervention name(s): Topiramate (drug)
Intervention type(s): Drug
Intervention description(s): Topiramate 25 mg to 200 mg
Other intervention name(s): Topamax
Intervention MeSH terms: Topiramate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment