Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00212810
Status:
COMPLETED
Last Update Posted:
2011-05-19
First Post:
2005-09-13
Brief Title:
Evaluation of the Effectiveness of Topiramate in Preventing the Transformation From Episodic Migraine to Chronic Daily Headache
Sponsor:
Ortho-McNeil Neurologics Inc
Organization:
Ortho-McNeil Neurologics Inc
Study Overview
Official Title:
TOPAMAX Topiramate Intervention to Prevent Transformation of Episodic Migraine The Topiramate INTREPID Study
Status:
COMPLETED
Status Verified Date:
2010-03
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:
The purpose of this study is to determine whether Topiramate is effective in preventing the development of chronic daily headache among patients with episodic migraine headaches
Detailed Description:
Chronic daily headache encompasses a frequent headache state in which the increased burden of pain further compromises quality of life and adversely impacts patients their families and health care providers Approximately 5 of patients with migraine or an estimated 14 million Americans manifest a chronic daily headache form of disease The consequences include resistance to treatment worsening quality of life increased use and over use of medication and development of ischemic and other neuropathological brain lesions This is a randomized double-blind placebo-controlled multicenter study that will enroll patients 18-65 years old with an established history of migraine headaches who in the 28 days prior to the study should have a migraine frequency of at least 10 but less than 15 migraine headache days per month and less than 15 total headache days migraine plus non migraine headaches per month The study duration will be approximately 26 weeks The study is divided into 4 phases as follows A ScreeningWashout Phase that may last between 2-6 weeks depending on whether you need to stop taking a medication that is not allowed in the study A Baseline Phase lasting 4 weeks at which time information will be collected on the migraine and non-migraine headaches you experience during this period A double-blind Titration Phase lasting 4-6 weeks where all patients will be randomized to treatment with either Topiramate or placebo If you are randomized to Topiramate your dose will be gradually increased up to a dose of either 75 or 100 mg a day A Maintenance Period lasting 20 weeks at which time you will continue on the dose you were taking at the completion of the Titration period and a TaperExit phase lasting 2 weeks where you will gradually reduce the dose of study medication you were taking during the study The study hypothesis is that the study drug will be more effective than placebo in preventing patients from transforming from episodic migraines to chronic daily headaches Each patient will be asked to record their headache pain information and medication use on paper headache diaries Patients will receive either Topiramate or placebo The number of tablets of topiramate or placebo will be gradually increased to either a minimum of 3 tabletsday or a maximum of 4 tabletsday For those on Topiramate 3 tablets would represent 75 mg and 4 tablets would represent 100 mgday
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