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

NCT00471952 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2012-04-25

No results posted yet for this study

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

Interventions

DRUG

Maxalt 10mg MLT plus Caffeine 75mg

One migraine attack will be treated

DRUG

Maxalt 10mg MLT plus Placebo

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

DRUG

Placebo + Placebo

One migraine attack will be treated with double placebo

Sponsors & Collaborators

Principal Investigators

  • Frederick G Freitag, DO · Diamond Headache Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2008-02-29
Completion
2008-04-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00471952 on ClinicalTrials.gov