Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00206323
Status:
COMPLETED
Last Update Posted:
2020-02-12
First Post:
2005-09-13
Brief Title:
A Randomized Placebo-controlled Tourette Syndrome Study
Sponsor:
Baylor College of Medicine
Organization:
Baylor College of Medicine
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ScreeningWashout Phase Double-Blind Phase and Taper Phase
SCREENINGWASHOUT 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 ScreeningWashout Visit Visit 1 of the study may have to be completed in two visits The screeningwashout 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 ScreeningWashout 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-DHD
TITRATIONMAINTANENCE 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 doctors 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 staffs 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 doi101136jnnp2009185348
SCREENINGWASHOUT 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 ScreeningWashout Visit Visit 1 of the study may have to be completed in two visits The screeningwashout 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 ScreeningWashout 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-DHD
TITRATIONMAINTANENCE 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 doctors 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 staffs 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 doi101136jnnp2009185348
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None