Maxalt 10mg Plus Caffeine 75mg in the Acute Treatment of Migraine Headache

• Status: Completed
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: All

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 headache attacks. Each subject will be dispensed one box containing 3 packets of study medication labeled for Headache #1, Headache #2, or Headache #3. Each packet wil contain either Maxalt 10mg MLT or a Maxalt placebo (sugar pill), and a capsule containing either caffeine 75mg or a capsule containing placebo (sugar).

One headache will be treated with a combination of Maxalt 10mg MLT and caffeine.

Another headache will be treated with a combination of Maxalt 10mg MLT and a capsule containing placebo.

A third headache will be treated with just placebo.

Neither the subject, the study coordinator, or your study doctor will know in which order you will receive the three different treatments. This information is available in case of emergency.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Diamond Headache Clinic
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Caffeine; Rizatriptan

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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