An Open-label Study to Determine the Efficacy and Safety of Topiramate in the Treatment of Tourette Syndrome.

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Brief Title

An Open-label Study to Determine the Efficacy and Safety of Topiramate in the Treatment of Tourette Syndrome.

Official Title

An Open-label Study to Determine the Efficacy and Safety of Topiramate in the Treatment of Tourette Syndrome (CAPSS-286)

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.
    

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.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Change in TTS


Condition

Tourette Syndrome

Intervention

Topiramate (drug)

Study Arms / Comparison Groups

 topiramate
Description:  Topiramate open label

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

20

Start Date

October 2004

Completion Date

December 2008

Primary Completion Date

December 2008

Eligibility Criteria

        Inclusion Criteria:

          -  Subjects must continue to meet the specific inclusion criteria outlined in either
             CAPSS-176 or CAPSS-198 to enroll in this protocol.

          -  Subjects must have completed the Double-Blind Phase or discontinued the Double-Blind
             Phase after a minimum of 6 weeks due to lack of efficacy (defined by a CGI improvement
             score of >6 [much worse or very much worse]) in either CAPSS-176 or CAPSS-198.

          -  Subjects or their parents/guardians, must be able to read and comprehend written
             instructions and willing to complete all scales and assessments required by this
             protocol.

          -  After full explanation of the study, subjects, or their parent/legally authorized
             representatives, must demonstrate their willingness to participate by signing an
             informed consent form. If applicable, pediatric subjects capable of giving assent must
             sign the assent form.

          -  Subjects must continue their current treatment for tics, treatment of comorbid
             symptoms or treatment of A-D/HD at the dose level established prior to entry in the
             Double-Blind Phase of CAPSS-176 or CAPSS-198.

        Exclusion Criteria:

          -  Subjects must continue to meet the specific exclusion criteria outlined in either
             CAPSS-176 or CAPSS-198 to enroll in this protocol.

          -  Subjects who have SGOT and/or SGPT levels greater than 2 times the upper limit of the
             normal range from the last visit in either CAPSS-176 or CAPSS-198 will not be
             permitted to enroll in the current study.
      

Gender

All

Ages

7 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Joseph Jankovic, MD, , 



Administrative Informations


NCT ID

NCT00206336

Organization ID

CAPSS-286


Responsible Party

Principal Investigator

Study Sponsor

Baylor College of Medicine

Collaborators

 Ortho-McNeil Janssen Scientific Affairs, LLC

Study Sponsor

Joseph Jankovic, MD, Principal Investigator, Baylor College of Medicine


Verification Date

October 2017