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Sponsors and Collaborators: |
Diamond Headache Clinic Merck |
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Information provided by: | Diamond Headache Clinic |
ClinicalTrials.gov Identifier: | NCT00471952 |
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.
Condition | Intervention | Phase |
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Migraine With Aura Migraine Without Aura |
Drug: Maxalt 10mg MLT plus Caffeine 75mg Drug: Maxalt 10mg MLT plus Placebo Drug: Placebo + Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | Maxalt 10mg Plus Caffeine 75mg in the Acute Treatment of Migraine Headache |
Estimated Enrollment: | 50 |
Study Start Date: | April 2007 |
Study Completion Date: | April 2008 |
Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Maxalt 10mg with Caffeine 75mg
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Drug: Maxalt 10mg MLT plus Caffeine 75mg
One migraine attack will be treated
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2: Active Comparator
Maxalt 10mg plus Placebo
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Drug: Maxalt 10mg MLT plus Placebo
One migraine attack will be treated with Maxalt 10mg plus placebo
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3: Placebo Comparator
Double placebo
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Drug: Placebo + Placebo
One migraine attack will be treated with double placebo
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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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Illinois | |
Diamond Headache Clinic | |
Chicago, Illinois, United States, 60614 |
Principal Investigator: | Frederick G Freitag, DO | Diamond Headache Clinic |
Responsible Party: | Diamond Headache Clinic ( Karin E. Brooks, BSN,RN Director of Clinical Research ) |
Study ID Numbers: | DHC 09 |
Study First Received: | May 8, 2007 |
Last Updated: | January 29, 2009 |
ClinicalTrials.gov Identifier: | NCT00471952 History of Changes |
Health Authority: | United States: Institutional Review Board |
Migraine |
Serotonin Agonists Caffeine citrate Neurotransmitter Agents Citric Acid Central Nervous System Diseases Central Nervous System Stimulants Headache Disorders, Primary Rizatriptan Brain Diseases |
Serotonin Headache Disorders Phosphodiesterase Inhibitors Migraine Disorders Headache Migraine with Aura Caffeine Migraine without Aura |
Serotonin Agonists Caffeine citrate Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Nervous System Diseases Central Nervous System Diseases Central Nervous System Stimulants Headache Disorders, Primary Enzyme Inhibitors Rizatriptan |
Brain Diseases Pharmacologic Actions Headache Disorders Serotonin Agents Phosphodiesterase Inhibitors Migraine Disorders Therapeutic Uses Migraine with Aura Caffeine Central Nervous System Agents Migraine without Aura |