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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00471952
Recruitment Status : Completed
First Posted : May 10, 2007
Last Update Posted : April 25, 2012
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Diamond Headache Clinic

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 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 or disease Intervention/treatment Phase
Migraine With Aura Migraine Without Aura Drug: Maxalt 10mg MLT plus Caffeine 75mg Drug: Maxalt 10mg MLT plus Placebo Drug: Placebo + Placebo Phase 3

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 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
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
Study Start Date : April 2007
Actual Primary Completion Date : February 2008
Actual Study Completion Date : April 2008

Arm Intervention/treatment
Experimental: 1
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
Double placebo
Drug: Placebo + Placebo
One migraine attack will be treated with double placebo

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. The comparative percentage of attacks that produce pain relief at 2 hours. [ Time Frame: 2 hours ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. Patient global evaluation for each of the treatments [ Time Frame: 24 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00471952

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United States, Illinois
Diamond Headache Clinic
Chicago, Illinois, United States, 60614
Sponsors and Collaborators
Diamond Headache Clinic
Merck Sharp & Dohme Corp.
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Principal Investigator: Frederick G Freitag, DO Diamond Headache Clinic
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Responsible Party: Diamond Headache Clinic Identifier: NCT00471952    
Other Study ID Numbers: DHC 09
First Posted: May 10, 2007    Key Record Dates
Last Update Posted: April 25, 2012
Last Verified: April 2012
Keywords provided by Diamond Headache Clinic:
Additional relevant MeSH terms:
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Migraine Disorders
Migraine without Aura
Migraine with Aura
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Serotonin Receptor Agonists
Serotonin Agents