- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00210912
A Study of the Effectiveness and Safety of Topiramate Versus Placebo for Preventing Chronic Migraine Headaches
A Comparison of the Efficacy and Safety of Topiramate Versus Placebo for the Prophylaxis of Chronic Migraine
Study Overview
Detailed Description
Migraine headaches can be disabling and can interfere with work and a person's quality of life. Preventing these headaches before they start is the best option. Topiramate, an anti-seizure medication, has been shown to help prevent migraine headaches from occurring. This is a multicenter, randomized, double-blind, placebo-controlled, parallel group study of patients with chronic migraine. The Pretreatment Phase for the study will last up to 56 days and will consist of 2 study periods: a Screening/Washout Period (Day -56 to Day -29) and a Prospective Baseline Period (28 days). Medications being used to prevent migraines will be stopped for 14 to 28 days prior to the Prospective Baseline Period and for the rest of the study. The Prospective Baseline Period will begin on study Day -28 (Visit 2), and patients will maintain a daily headache record during this period. Those who move forward in the study must have had at least 15 headache days during this period, half of which need to be migraine headache days. Patients who finish the Prospective Baseline Period, who have the required rates of headache, and who continue to meet the remainder of the entry criteria will be randomized (like with the toss of a coin) to 1 of 2 treatment groups: topiramate 100 milligrams per day or placebo. The Double-Blind Phase will last 16 weeks. During the first 4 weeks, patients will titrate up to the topiramate dose of 100 milligrams per day or to the maximum tolerated dose, whichever is less. The next 12 weeks is the maintenance phase where you will continue to take the dose that you were taking at the end of the 4-week titration period. The primary hypothesis of this study is that the mean decrease in the number of migraine/migrainous headache days per month is greater in the topiramate group than in the placebo group and topiramate is generally well-tolerated.
Topiramate 25 milligram tablets, 2 tablets by mouth twice daily, or maximum tolerated dose, whichever is less, for 12 weeks, or 2 placebo tablets twice daily for 12 weeks
Study Type
Enrollment (Actual)
Phase
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosis of chronic migraine
- >=15 headache days per month in past 30 days
- >= 15 headache days, half of which need to be migraine headaches during the prospective baseline period
- MIDAS test score >= 11 at Visit 1
- In generally good health
- If female, using birth control
- No abnormalities on neurological examination
Exclusion Criteria:
- Failed > 2 adequate trials of migraine prevention medications
- Failed topiramate due to lack of effectiveness or adverse events
- Daily headaches of severe intensity during past 30 days
- Cluster, basilar, ophthalmoplegic, or hemiplegic migraines
- Migraines started after age 50
- Other pain greater than migraine pain
- Use of drugs to treat migraines for > 4 days per week during the past month
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Change in the average number of days per month with migraine or migrainous headache by daily headache record.
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Secondary Outcome Measures
Outcome Measure |
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Absolute change and % change from baseline in the headache index; change in the average daily and worst daily headache severity; quality of life assessments (MIDAS, MSQ, Physician's/Subject's global assessments of change.
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Collaborators and Investigators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR004684
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Migraine
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Tonix Pharmaceuticals, Inc.PremierCompletedChronic Migraine | Chronic Migraine, Headache | Chronic Migraine Without Aura | Aura MigraineUnited States
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The Cleveland ClinicWithdrawnMigraine | Migraine Disorders | Headache Disorders, Primary | Migraine Headache | Migraine Without Aura | Migraine With Aura | Headache, MigraineUnited States
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