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

NCT00471952 | Completed Phase 3

• 1 other identifier: DHC 09
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine With Aura; Migraine Without Aura

Keywords

Migraine

Outcome Measures

Primary Outcomes (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.

  2 hours

Secondary Outcomes (5)

• The comparative percentage of attacks that produce pain relief at 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.

  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.

  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.

  24 hours

• Patient global evaluation for each of the treatments

  24 hours

Study Arms (3)

1

EXPERIMENTAL

Maxalt 10mg with Caffeine 75mg

Drug: Maxalt 10mg MLT plus Caffeine 75mg

2

ACTIVE COMPARATOR

Maxalt 10mg plus Placebo

Drug: Maxalt 10mg MLT plus Placebo

3

PLACEBO COMPARATOR

Double placebo

Drug: Placebo + Placebo

Interventions

Maxalt 10mg MLT plus Caffeine 75mg DRUG

One migraine attack will be treated

1

Maxalt 10mg MLT plus Placebo DRUG

One migraine attack will be treated with Maxalt 10mg plus placebo

2

Placebo + Placebo DRUG

One migraine attack will be treated with double placebo

3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is 18-65 years of age
• Diagnosis of migraine with or without aura
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Diamond Headache Clinic: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Diamond Headache Clinic

Chicago, Illinois, 60614, United States

Location

MeSH Terms

Conditions

Migraine with Aura; Migraine without Aura; Migraine Disorders

Interventions

rizatriptan; Caffeine

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Frederick G Freitag, DO

  Diamond Headache Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2007
• First Posted: May 10, 2007
• Study Start: April 1, 2007
• Primary Completion: February 1, 2008
• Study Completion: April 1, 2008
• Last Updated: April 25, 2012

Record last verified: 2012-04

Locations

US (1)