The Effectiveness of Almotriptan Malate (AXERT®) 12.5 Milligrams When Taken at the Onset of Migraine Pain

• Status: Completed
• Trial end date: 2005-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effectiveness and safety of AXERT when treating a migraine at the onset of headache pain, as compared to treating a migraine only after the headache pain has reached at least moderate intensity..

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

Details

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

Criteria

Inclusion Criteria:

• History of a confirmed diagnosis of migraine headache with or without aura that meets the International Headache Society (IHS) criteria of migraine headache for at least 1 year

• Average frequency of 1 - 6 migraine headaches per month over the past 3 months

• History of migraine headaches of at least moderate pain intensity within the past year

• If taking a medication for migraine prophylaxis, taking a maintenance dose for at least 4 weeks prior to Visit 1, and remaining on a stable dose for the duration of the study

• In generally good health

• Capable of taking oral medication, perform study procedures and follow directions regarding collection of study information, e.g., subjects must be able and willing to read and comprehend written instructions, use a stopwatch, and comprehend and complete the telephone requirements, and must be willing to return to the office for a final study visit

• If female of childbearing potential, using birth control

Exclusion Criteria:

• Onset of migraine after age 50

• Chronic migraine or chronic tension-type headache defined by having 15 or more headache days per month in the previous 6 months

• Exclusively migraine aura without headache, or headaches that occur predominantly upon awakening in the morning

• Patients in whom triptans are contraindicated or who have previously discontinued AXERT therapy due to adverse events, history of substance abuse, or chronic alcohol abuse within the past 6 months