Status:
COMPLETED
Maxalt 10mg Plus Caffeine 75mg in the Acute Treatment of Migraine Headache
Lead Sponsor:
Diamond Headache Clinic
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Migraine With Aura
Migraine Without Aura
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the effect of rizatriptan, alone or combined with caffeine for treating acute attacks of migraine. Each subject will have 3 months to treat 3 acute migraine h...
Detailed Description
Oral Maxalt has an extensive record of providing relief of acute migraine headache with 2 hours in the vast majority of patients, especially when undertaken as an early intervention strategy. Caffeine...
Eligibility Criteria
Inclusion
- Subject is 18-65 years of age
- Diagnosis of migraine with or without aura
- 1 year history of migraine with 1-6 migraine attacks per month in the the three months prior to screening
- Medication for migraine prevention with a stable dose for at least 1 month prior to screening
- Has successfully treated a migraine attack with a triptan medication
Exclusion
- Confirmed or suspected ischemic heart disease
- History of congenital heart disease
- History of cerebrovascular disease, including stroke
- History of ischemic abdominal disease
- Uncontrolled hypertension
- History of epilepsy
- History of basilar or hemiplegic migraine
- Impaired hepatic or renal function
- Greater than 15 headache days per month
- Subjects on an MAOI
- Subjects taking and ergotamine, or ergot containing preventive medication
- Subject is pregnant, trying to become pregnant or breast feeing
- Evidence of alcohol or substance abuse in the last year
- History of caffeine withdrawal headache
- Consumes more than 275 mg of caffeine on daily basis from dietary and medication sources
- Taking propanolol
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00471952
Start Date
April 1 2007
End Date
April 1 2008
Last Update
April 25 2012
Active Locations (1)
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1
Diamond Headache Clinic
Chicago, Illinois, United States, 60614