A Study of the Effectiveness and Safety of Almotriptan Versus Placebo in the Treatment of Migraine Headache

• Status: Completed
• Trial end date: 2005-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effectiveness and safety of almotriptan malate (AXERT®) 12.5 milligram tablets compared with placebo for the acute treatment of migraine headache at the earliest onset of headache pain. Almotriptan malate (AXERT®) is approved for the treatment of migraine headache, with or without aura, in adults. Patients in this study will take either almotriptan or placebo oral tablets for 3 consecutive migraine headaches.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen-Ortho LLC
• Collaborator: Ortho-McNeil Neurologics, Inc.
• Treatments: Almotriptan

Criteria

Inclusion Criteria:

• Diagnosis of migraine, with or without aura

• At least moderate pain with migraines

• Average of 2 to 6 migraines per month for past 3 months

• Duration of headache pain at least 4 hours

• Able to tell the difference between a migraine and a tension headache

• If taking a medication to prevent migraines, patients must have been taking a maintenance dose for at least 30 days before screening

• In generally good health

• If female, using birth control

Exclusion Criteria:

• Routinely experience other type of headache that might seem like a migraine headache

• An average of 15 or more headache days per month in the past 6 months

• Migraines began after age 50

• Taking > 1 medicine for preventing migraines

• Use of any drugs on list of prohibited drugs, of opioid drugs in past 7 days, of corticosteroids in the past 30 days, of an investigational drug within 30 days

• Use of non-drug treatment for migraine in past 14 days unless have used this treatment for > 14 days and plan to continue throughout study

• Overuse of medications that treat pain or nausea

• Migraine aura without headache

• Hemiplegic or basilar migraines

• Usually have vomiting with headache

• Headaches that usually occur upon waking

• Significant unstable medical disease

• Abnormal liver, kidney, blood, or ECG laboratory or test results

• Abusing drugs or alcohol

• History of a significant mental disorder

• Pregnant or breast-feeding