The Effectiveness of Almotriptan Malate (AXERT®) 12.5 Milligrams When Taken at the Onset of Migraine Pain
Information source: Ortho-McNeil Neurologics, Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
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.
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..
Clinical Details
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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Duration of migraine pain measured from onset of pain to no pain.
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).
Eligibility
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
Locations and Contacts
Additional Information
AXERT 12.5mg Time vs Intensity - Migraine Study (AIMS)
Starting date: June 2004
Last updated: May 17, 2011
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