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

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Diamond Headache Clinic
ClinicalTrials.gov Identifier:
NCT00471952
First received: May 8, 2007
Last updated: April 24, 2012
Last verified: April 2012
  Purpose

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
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 Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Maxalt 10mg Plus Caffeine 75mg in the Acute Treatment of Migraine Headache

Resource links provided by NLM:


Further study details as provided by Diamond Headache Clinic:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The comparative percentage of attacks that produce pain relief at 2 hours. [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Patient global evaluation for each of the treatments [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

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
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00471952

Locations
United States, Illinois
Diamond Headache Clinic
Chicago, Illinois, United States, 60614
Sponsors and Collaborators
Diamond Headache Clinic
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Frederick G Freitag, DO Diamond Headache Clinic
  More Information

No publications provided

Responsible Party: Diamond Headache Clinic
ClinicalTrials.gov Identifier: NCT00471952     History of Changes
Other Study ID Numbers: DHC 09
Study First Received: May 8, 2007
Last Updated: April 24, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Diamond Headache Clinic:
Migraine

Additional relevant MeSH terms:
Headache
Migraine Disorders
Migraine with Aura
Migraine without Aura
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Caffeine
Rizatriptan
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Serotonin Receptor Agonists
Serotonin Agents

ClinicalTrials.gov processed this record on August 27, 2014