A 1-year Study in Adolescents to Assess the Long-term Safety of Almotriptan Malate When Treating Their Migraine Headaches

Completed · Phase 3

Conditions studied: Migraine

In brief

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.

Key facts

Study ID

NCT00257010

Run by

Janssen-Ortho LLC

People needed

447

Starts

2005-12-01

Expected to finish

2007-12-01

Last updated by the study team

2014-02-21

Who can join

Age: 12 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Study site — Mobile, Alabama, United States
• Study site — Montgomery, Alabama, United States
• Study site — Oxford, Alabama, United States
• Study site — Mesa, Arizona, United States
• Study site — Phoenix, Arizona, United States
• Study site — Jonesboro, Arkansas, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Santa Monica, California, United States
• Study site — Centennial, Colorado, United States
• Study site — Denver, Colorado, United States
• Study site — Loxahatchee Groves, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — West Palm Beach, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Snellville, Georgia, United States
• Study site — Idaho Falls, Idaho, United States
• Study site — Chicago, Illinois, United States
• Study site — Des Moines, Iowa, United States
• Study site — Topeka, Kansas, United States
• Study site — Witchita, Kansas, United States
• Study site — Louisville, Kentucky, United States
• Study site — Ann Arbor, Michigan, United States
• Study site — Columbia, Missouri, United States

Full record on ClinicalTrials.gov

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