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

April 24, 2012 updated by: Diamond Headache Clinic

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60614
        • Diamond Headache Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
2 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
The comparative percentage of attacks that produce pain relief at 2 hours.
Time Frame: 2 hours
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
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
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
24 hours
Patient global evaluation for each of the treatments
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Diamond Headache Clinic

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Principal Investigator: Frederick G Freitag, DO, Diamond Headache Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

May 8, 2007

First Submitted That Met QC Criteria

May 9, 2007

First Posted (Estimate)

May 10, 2007

Study Record Updates

Last Update Posted (Estimate)

April 25, 2012

Last Update Submitted That Met QC Criteria

April 24, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DHC 09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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