Maxalt 10mg Plus Caffeine 75mg in the Acute Treatment of Migraine Headache
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.
|Migraine With Aura Migraine Without Aura||Drug: Maxalt 10mg MLT plus Caffeine 75mg Drug: Maxalt 10mg MLT plus Placebo Drug: Placebo + Placebo||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
|Official Title:||Maxalt 10mg Plus Caffeine 75mg in the Acute Treatment of Migraine Headache|
- The comparative percentage of migraine attacks that produce pain free response at 2 hours in the Maxalt 10mg MLT plus caffeine 75mg arm versus the Maxalt 10mg MLT plus placebo caffeine versus double placebo. [ Time Frame: 2 hours ]
- The comparative percentage of attacks that produce pain relief at 2 hours. [ Time Frame: 2 hours ]
- The comparative percentage of attacks that produce a pain free response and do not require re-treatment during the subsequent 24 hours and are not associated with headache pain recurrence. [ Time Frame: 24 hours ]
- The comparative percentage of resolution of associated symptoms of migraine present at the time of treatment as well as achieving a pain free response within 2 hours with each of the treatments. [ Time Frame: 2 hours ]
- The comparative number of patients reporting adverse effects to study medication, the type of adverse events reported and the percentage of attacks that are associated with the adverse effect. [ Time Frame: 24 hours ]
- Patient global evaluation for each of the treatments [ Time Frame: 24 hours ]
|Study Start Date:||April 2007|
|Study Completion Date:||April 2008|
|Primary Completion Date:||February 2008 (Final data collection date for primary outcome measure)|
Maxalt 10mg with Caffeine 75mg
Drug: Maxalt 10mg MLT plus Caffeine 75mg
One migraine attack will be treated
Active Comparator: 2
Maxalt 10mg plus Placebo
Drug: Maxalt 10mg MLT plus Placebo
One migraine attack will be treated with Maxalt 10mg plus placebo
Placebo Comparator: 3
Drug: Placebo + Placebo
One migraine attack will be treated with double placebo
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 has been demonstrated to have analgesic effects in patients treating tension type headache and is found as part of a combination including aspirin and acetaminophen as a treatment for acute migraine headache.
The mechanism by which Maxalt relieves migraine headache is believed to be through action on 5HT1B/1D receptors both on blood vessels as well as centrally. Caffeine may have effects on relief of migraine through modifying norepinephrine related mechanisms which have been suggested through clinical research. Patients commonly report that they may obtain partial or complete relief of their migraines by consuming the modest amounts of caffeine found in a cup of coffee. this is estimated to be approximately 100mg per cup. The analgesic effects of caffeine appear to be most significant in the first 3 hours after ingestion. Recent work suggests that intervention in migraine when the pain is still mild and has not persisted for a prolonged duration may increase the likelihood of complete migraine response. Therefore, the combination of the two agents with activity in migraine that work early in the migraine process, have good tolerability at the proposed doses and working via different mechanism may increase the likelihood of patients achieving better response with their migraine treatment than that which is currently available.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00471952
|United States, Illinois|
|Diamond Headache Clinic|
|Chicago, Illinois, United States, 60614|
|Principal Investigator:||Frederick G Freitag, DO||Diamond Headache Clinic|