Status:
COMPLETED
A 1-year Study in Adolescents to Assess the Long-term Safety of Almotriptan Malate When Treating Their Migraine Headaches
Lead Sponsor:
Janssen-Ortho LLC
Collaborating Sponsors:
Ortho-McNeil Neurologics, Inc.
Conditions:
Migraine
Eligibility:
All Genders
12-17 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the long-term safety of almotriptan malate (a migraine headache medication) in the treatment of migraine headaches in adolescents for up to one year.
Detailed Description
Almotriptan malate, and several other treatments for migraine headaches, known as triptans, are approved for the treatment of migraine headaches in adults. To date, none of these have been approved by...
Eligibility Criteria
Inclusion
- Have a history of migraine for at least one year
- Have an average of 1 - 14 migraines per month for the 6 months prior to study entry
- Able to swallow oral medication
- Able to complete a headache diary
- Only taking one migraine preventive medication and on the same dose of that medication for at least 30 days before entering the study)
Exclusion
- Have an allergy to almotriptan malate or have stopped taking almotriptan malate due to side effects
- Have 15 or more days within a month in which you have a headache
- Usually experience migraine aura (most common symptoms being visual disturbances or tingling sensations before migraine pain begins) without a headache
- Experience more than 6 non-migraine headaches per month
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
447 Patients enrolled
Trial Details
Trial ID
NCT00257010
Start Date
December 1 2005
End Date
December 1 2007
Last Update
February 21 2014
Active Locations (49)
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1
Mobile, Alabama, United States
2
Montgomery, Alabama, United States
3
Oxford, Alabama, United States
4
Mesa, Arizona, United States