Status:
COMPLETED
The Effectiveness of Almotriptan Malate (AXERT®) 12.5 Milligrams When Taken at the Onset of Migraine Pain
Lead Sponsor:
Ortho-McNeil Neurologics, Inc.
Conditions:
Migraine
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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 h...
Detailed Description
AXERT has been approved by the FDA for the treatment of migraine headache with or without aura in adults. Early treatment of a migraine headache, independent of headache pain intensity symptoms, may p...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2005
Estimated Enrollment :
1450 Patients enrolled
Trial Details
Trial ID
NCT00212823
Start Date
June 1 2004
End Date
February 1 2005
Last Update
May 19 2011
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