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

NCT00212823 | Completed Phase 4

• 1 other identifier: CR004708
• Study Type: interventional
• Target: 1,450
• Locations: 0 countries
• Sites: N/A

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 has reached at least moderate intensity..

Conditions

Migraine

Keywords

Migraine

Outcome Measures

Primary Outcomes (1)

• Duration of migraine pain measured from onset of pain to no pain.

Interventions

almotriptan malate DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ortho-McNeil Neurologics, Inc.: lead

Related Publications (1)

• Freitag FG, Finlayson G, Rapoport AM, Elkind AH, Diamond ML, Unger JR, Fisher AC, Armstrong RB, Hulihan JF, Greenberg SJ; AIMS Investigators. Effect of pain intensity and time to administration on responsiveness to almotriptan: results from AXERT 12.5 mg Time Versus Intensity Migraine Study (AIMS). Headache. 2007 Apr;47(4):519-30. doi: 10.1111/j.1526-4610.2007.00756.x.

  PMID: 17445101 RESULT

Related Links

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

MeSH Terms

Conditions

Migraine Disorders

Interventions

almotriptan

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Ortho McNeil Neurologics, Inc. Clinical Trial

  Ortho-McNeil Neurologics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: June 1, 2004
• Study Completion: February 1, 2005
• Last Updated: May 19, 2011

Record last verified: 2010-04