A 1-year Study in Adolescents to Assess the Long-term Safety of Almotriptan Malate When Treating Their Migraine Headaches
A 1-year Study in Adolescents to Assess the Long-term Safety of Almotriptan Malate When Treating Their Migraine Headaches
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.
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.
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 medication
 for at least 30 days before entering the study)

 Exclusion Criteria:

 -  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