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.
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.
Minimum age: 12 Years.
Maximum age: 17 Years.
Gender(s): Both.
Mobile, Alabama, United States
Montgomery, Alabama, United States
Oxford, Alabama, United States
Mesa, Arizona, United States
Phoenix, Arizona, United States
Jonesboro, Arkansas, United States
Little Rock, Arkansas, United States
Santa Monica, California, United States
Centennial, Colorado, United States
Denver, Colorado, United States
Loxahatchee, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Tampa, Florida, United States
West Palm Beach, Florida, United States
Atlanta, Georgia, United States
Snellville, Georgia, United States
Idaho Falls, Idaho, United States
Chicago, Illinois, United States
Des Moines, Iowa, United States
Topeka, Kansas, United States
Witchita, Kansas, United States
Louisville, Kentucky, United States
Ann Arbor, Michigan, United States
Columbia, Missouri, United States
Saint Louis, Missouri, United States
Springfield, Missouri, United States
Endwell, New York, United States
Mineola, New York, United States
Mount Vernon, New York, United States
Plainview, New York, United States
Raleigh, North Carolina, United States
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Oklahoma City, Oklahoma, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Alcoa, Tennessee, United States
Bristol, Tennessee, United States
Germantown, Tennessee, United States
Morristown, Tennessee, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
San Marcos, Texas, United States
Salt Lake City, Utah, United States
Madison, Wisconsin, United States