A Randomized, Placebo-controlled, Tourette Syndrome Study.

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Brief Title

A Randomized, Placebo-controlled, Tourette Syndrome Study.

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 (CAPSS-176)

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

      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
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Change From Baseline in Total Tic Score at Day 70


Condition

Tourette Syndrome

Intervention

Topiramate (drug)

Study Arms / Comparison Groups

 placebo/sugar pill
Description:  Placebo or sugar pill

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

29

Start Date

September 2004

Completion Date

December 2008

Primary Completion Date

December 2008

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
      

Gender

All

Ages

7 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Joseph Jankovic, MD, , 



Administrative Informations


NCT ID

NCT00206323

Organization ID

H-13552


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

January 2020