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

Phase

Condition

Pain

Pain (Pediatric)

Headaches

Treatment

N/A

Clinical Study ID

NCT00257010

CR002827

CAPSS-368

Ages 12-17
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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 medicationfor at least 30 days before entering the study)

Exclusion

Exclusion Criteria:

Have an allergy to almotriptan malate or have stopped taking almotriptan malate due toside 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 ortingling sensations before migraine pain begins) without a headache
Experience more than 6 non-migraine headaches per month

Study Design

December 01, 2005

December 31, 2007

Study 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 the Food and Drug Administration (FDA) for use in adolescents. This is an open-label, multi-center study that will enroll approximately 450 patients aged 12 - 17 years old with a history of one to 14 migraines per month for the 6 months prior to entering the study. The total study duration will be up to one year. There is a screening phase to determine if the patient is eligible for study entry, followed by an open-label treatment phase that can last up to one year. Almotriptan malate 12.5 mg tablets will be used to treat all migraine headaches during the study, as needed. The primary outcome of the study is an assessment of the long-term safety of almotriptan malate in adolescent migraine sufferers. The study hypothesis is that the almotriptan malate will be safe and well tolerated in the treatment of adolescent migraine headaches. Safety measurements will be performed at set time points during the study and will include laboratory tests, physical and neurological exams, electrocardiograms (ECGs) and the incidence of adverse events. A diary will be completed by the patient for each migraine headache for which they take almotriptan malate. Migraine pain information and almotriptan malate use will be recorded in the headache diary. An equal number of patients in the 12 - 14 year old range as the 15 - 17 year old range will be enrolled. Patients will take one 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain. The dose may be repeated once if the pain continues 2 hours after the first dose, but no more than 2 doses can be taken within a 24-hour period. Study medication will be taken for up to one year.

Connect with a study center

Mobile, Alabama
United States
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Montgomery, Alabama
United States
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Oxford, Alabama
United States
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Mesa, Arizona
United States
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Phoenix, Arizona
United States
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Jonesboro, Arkansas
United States
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Little Rock, Arkansas
United States
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Santa Monica, California
United States
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Centennial, Colorado
United States
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Denver, Colorado
United States
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Loxahatchee, Florida
United States
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Miami, Florida
United States
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Orlando, Florida
United States
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Tampa, Florida
United States
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West Palm Beach, Florida
United States
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Atlanta, Georgia
United States
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Snellville, Georgia
United States
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Idaho Falls, Idaho
United States
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Chicago, Illinois
United States
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Des Moines, Iowa
United States
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Topeka, Kansas
United States
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Witchita, Kansas
United States
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Louisville, Kentucky
United States
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Ann Arbor, Michigan
United States
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Columbia, Missouri
United States
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Saint Louis, Missouri
United States
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Springfield, Missouri
United States
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Endwell, New York
United States
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Mineola, New York
United States
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Mount Vernon, New York
United States
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Plainview, New York
United States
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Raleigh, North Carolina
United States
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Cincinnati, Ohio
United States
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Columbus, Ohio
United States
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Oklahoma City, Oklahoma
United States
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Philadelphia, Pennsylvania
United States
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Pittsburgh, Pennsylvania
United States
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Alcoa, Tennessee
United States
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Bristol, Tennessee
United States
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Germantown, Tennessee
United States
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Morristown, Tennessee
United States
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Nashville, Tennessee
United States
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Dallas, Texas
United States
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Fort Worth, Texas
United States
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Houston, Texas
United States
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San Antonio, Texas
United States
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San Marcos, Texas
United States
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Salt Lake City, Utah
United States
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Madison, Wisconsin
United States
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