Tourette SyndromePhase 3NCT00206336
An Open-label Study to Determine the Efficacy and Safety of Topiramate in the Treatment of Tourette Syndrome.
A Phase 3 study testing Topiramate (drug) in people with Tourette Syndrome, run by Baylor College of Medicine.
Trial 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… Read more about this study
- Who is it for?
- Ages 7 to 65 years
- Conditions the study is for
- Tourette Syndrome
- What is being tested?
- Topiramate (drug)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Oct 2004to Dec 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: An Open-label Study to Determine the Efficacy and Safety of Topiramate in the Treatment of Tourette Syndrome (CAPSS-286)
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.
Read the 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.
- Conditions
- Tourette Syndrome
- Being tested
- Topiramate (drug)
- Medical subject headings
- Tourette Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topiramate (drug)Drug
Also called Topamax
Topiramate 25 mg to 200 mg
| Study group | Role | What they receive |
|---|---|---|
| topiramate | Experimental | Topiramate open label Receives: Drug: Topiramate (drug) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in TTS
A component of the Yale Global Tic Severity Scale (YGTSS), the change from baseline in Total Tic Score (TTS) at visit 5 (day 70) is the pre-defined primary endpoint. The Total Tic Score is a summation of the Total Motor Tic and Total Phonic Tic Scores. The Overall Impairment Rating is rated on a 50-point scale anchored by 0 (No impairment) and 50 (Severe impairment).
Measured: baseline to Day 70
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startOct 2004
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tourette SyndromeStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Ortho-McNeil Janssen Scientific Affairs, LLC
- Responsible party
- Principal investigator, Joseph Jankovic, Baylor College of Medicine
- Investigators
- Joseph Jankovic, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00206336
- Sponsor's protocol ID
- CAPSS-286
- Status last verified
- Oct 2017
- First submitted
- 13 Sep 2005
- Last updated
- 6 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Jankovic J, Jimenez-Shahed J, Brown LW. A randomised, double-blind, placebo-controlled study of topiramate in the treatment of Tourette syndrome. J Neurol Neurosurg Psychiatry. 2010 Jan;81(1):70-3. doi: 10.1136/jnnp.2009.185348. Epub 2009 Sep 1.
PubMed 19726418
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Study to Determine the Efficacy and Safety of Topiramate in the Treatment of Tourette Syndrome (CAPSS-286)
- ClinicalTrials.gov ID
- NCT00206336
- Acronym / sponsor ID
- CAPSS-286
- Conditions
- Tourette Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- Ortho-McNeil Janssen Scientific Affairs, LLC
- Study start
- Oct 2004
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Posted 6 Nov 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| topiramate | Experimental | Drug: Topiramate (drug)Topiramate open label |
Who may qualify
- Ages
- 7 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topiramate (drug)Also: TopamaxTopiramate 25 mg to 200 mg | Drug | topiramate |
Primary outcome
Change in TTS
Time frame: baseline to Day 70
A component of the Yale Global Tic Severity Scale (YGTSS), the change from baseline in Total Tic Score (TTS) at visit 5 (day 70) is the pre-defined primary endpoint. The Total Tic Score is a summation of the Total Motor Tic and Total Phonic Tic Scores. The Overall Impairment Rating is rated on a 50-point scale anchored by 0 (No impairment) and 50 (Severe impairment).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19726418Jankovic J, Jimenez-Shahed J, Brown LW. A randomised, double-blind, placebo-controlled study of topiramate in the treatment of Tourette syndrome. J Neurol Neurosurg Psychiatry. 2010 Jan;81(1):70-3. doi: 10.1136/jnnp.2009.185348. Epub 2009 Sep 1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Jankovic, MD principal investigator
Baylor College of Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Topiramate (drug) in people with Tourette Syndrome, run by Baylor College of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in TTS (time frame: baseline to Day 70). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00206336, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2017.