The Effectiveness of Almotriptan Malate (AXERT®) 12.5 Milligrams When Taken at the Onset of Migraine Pain
|ClinicalTrials.gov Identifier: NCT00212823|
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : May 19, 2011
|Condition or disease||Intervention/treatment||Phase|
|Migraine||Drug: almotriptan malate||Phase 4|
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 provide the optimal therapeutic response. This is a multi-center, open label study to test the efficacy (effectiveness) and tolerability of AXERT when treating a migraine at the onset of headache pain versus treating a migraine only after the headache pain has reached at least moderate intensity. Patients will self-administer 12.5 milligrams of AXERT for the treatment of 2 migraine headaches. Centers will be randomly assigned to 1 of 2 treatment interventions in which patients will sequentially treat both migraine headaches with 12.5 milligrams of AXERT using either the early treatment regimen (ET; ie, at the onset of pain) or conditional treatment regimen (CT; ie, after the headache has reached at least moderate intensity). Data will be collected regarding treatment response during and after each migraine headache. For each headache, patients will record study information and data during 3 telephone calls using Interactive Voice Response System (IVRS) technology. It is expected that patients who take 12.5 milligrams of AXERT at the first sign of pain of any intensity due to a migraine headache will experience an overall shorter duration of their migraine than patients who take AXERT 12.5 mg when their migraine pain has reached at least moderate pain intensity. In addition, it is expected that almotriptan malate (AXERT®) is generally well-tolerated.
AXERT 12.5 milligram tablet orally either at the onset of migraine pain (within 1 hour of the start of a migraine-ET regimen) or when migraine pain reaches at least moderate intensity (CT regimen).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1450 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||AXERT® 12.5mg Time vs Intensity Migraine Study (AIMS): An Open-label Multicenter Trial to Evaluate the Efficacy of Almotriptan Malate (AXERT®) 12.5 Milligram Intervention at Onset of Migraine Pain|
|Study Start Date :||June 2004|
|Actual Study Completion Date :||February 2005|
- Duration of migraine pain measured from onset of pain to no pain.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00212823
|Study Director:||Ortho McNeil Neurologics, Inc. Clinical Trial||Ortho-McNeil Neurologics, Inc.|