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| Sponsor: | Janssen-Ortho Inc., Canada |
|---|---|
| Information provided by: | Janssen-Ortho Inc., Canada |
| ClinicalTrials.gov Identifier: | NCT00261469 |
Purpose
The purpose of this study is to evaluate whether prophylactic use of topiramate (preventative use before a migraine attack) enhances the effectiveness of migraine treatment with triptans.
| Condition | Intervention | Phase |
|---|---|---|
|
Headache |
Drug: topiramate |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Efficacy of Topiramate Prophylaxis as Add-on to Triptan Therapy for Migraine |
| Estimated Enrollment: | 40 |
| Study Start Date: | April 2003 |
| Estimated Study Completion Date: | November 2004 |
The objective of this pilot study is to determine if patients with migraine are more responsive to triptans taken for symptomatic headache treatment while on topiramate prophylactic therapy as compared to a baseline period without prophylaxis. The trial is an open-label design, with migraine patients receiving topiramate prophyltically twice a day (maximum of 200 mg/day) for 16 weeks, following a 6-week Prospective Baseline Period. During the first week of the treatment phase, subjects will begin on a once-daily dose of 25 mg of topiramte at night, and remain on that dose for two weeks. Thereafter, the daily dose will be increased by 25 mg, with twice-daily dosing. If in the investigator's judgement further dosage increases beyond 100 mg/day are indicated, the daily dose will be increased weekly by 25 mg to a daily dose of 150 mg. The daily dose may be increased to a maximum daily dose of 200 mg, if the subject is tolerating the higher doses. Subjects keep a headache diary in which the following information is recorded: time of onset of headache and indication of type of headache; time headache stops; any symptomatic treatment taken, time that tiptan medication is taken; headache intensity at the time the triptan is taken, 30 minutes, one hour, and two hours post dose; and the presence of nausea at the time the triptan is taken, 30 minutes, on hour, and 2 hours post dose. The primary measure of triptan responsiveness is the proportion of triptan treated migraine attacks that were pain-free at two hours after triptan treatment. Safety evaluations during the study include the collection of adverse events, laboratory assessments including hematology, chemistry and urinalysis, and vital signs (blood pressure and pulse). The hypothesis is that topiramate prophylaxis will increase the responsiveness of migraine attacks to triptan therapy as measured by the proportion of attacks that are pain-free two hours after triptan therapy.
Subjects will begin week 1 of the Topiramate Treatment phase with 25 mg topiramate at night. Thereafter, the dose of topiramate will be increased by 25 mg every second week i.e. week 3 = 50 mg, week 5 =75 mg, week 7 = 100 mg. If, in the investigator's judgment, further dosage increases are indicated, the dose can be increased as follows: week 9 = 125 mg, week 10 = 150 mg, week 11 = 175 mg, week 12 = 200 mgs.The dose may be increased weekly after week 10 if the patient is tolerating the higher.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Study ID Numbers: | CR005686 |
| Study First Received: | December 2, 2005 |
| Last Updated: | April 6, 2007 |
| ClinicalTrials.gov Identifier: | NCT00261469 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Migraine Headache |
|
Physiological Effects of Drugs Nervous System Diseases Central Nervous System Diseases Pain Headache Disorders, Primary Brain Diseases Protective Agents Neuroprotective Agents Pharmacologic Actions Headache Disorders |
Anti-Obesity Agents Signs and Symptoms Migraine Disorders Therapeutic Uses Headache Neurologic Manifestations Topiramate Central Nervous System Agents Anticonvulsants |