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

Condition(s) targeted: Migraine

Intervention: almotriptan malate (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Ortho-McNeil Neurologics, Inc.

Official(s) and/or principal investigator(s):
Ortho McNeil Neurologics, Inc. Clinical Trial, Study Director, Affiliation: Ortho-McNeil Neurologics, Inc.

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..

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 design: Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study

Primary outcome: Duration of migraine pain measured from onset of pain to no pain.

Secondary outcome:

Efficacy: Duration of migraine pain from time patients take medication to no pain

presence or absence of pain at 24 hours after onset; use of additional medication for migraine pain; satisfaction with AXERT;quality of life. Safety: adverse events reports

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 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).

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

AXERT 12.5mg Time vs Intensity - Migraine Study (AIMS)

Starting date: June 2004
Ending date: February 2005
Last updated: March 24, 2008