A 1-year Study in Adolescents to Assess the Long-term Safety of Almotriptan Malate When Treating Their Migraine Headaches

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the long-term safety of almotriptan malate (a migraine headache medication) in the treatment of migraine headaches in adolescents for up to one year.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Have a history of migraine for at least one year

• Have an average of 1 - 14 migraines per month for the 6 months prior to study entry

• Able to swallow oral medication

• Able to complete a headache diary

• Only taking one migraine preventive medication and on the same dose of that medication for at least 30 days before entering the study)

Exclusion Criteria:

• Have an allergy to almotriptan malate or have stopped taking almotriptan malate due to side effects

• Have 15 or more days within a month in which you have a headache

• Usually experience migraine aura (most common symptoms being visual disturbances or tingling sensations before migraine pain begins) without a headache

• Experience more than 6 non-migraine headaches per month