Adolescent Migraine Study

from Practice Update, Fall 2006

The American Academy of Neurology estimates that migraines occur in four to 11 percent of elementary school children and up to 23 percent of teenagers. Almotriptan malate, and several other treatments for migraine headaches, known as triptans, have been shown to be effective in the treatment of migraine headaches in adults. To date, general use of triptans in adolescents has not yet been approved by the Food and Drug Administration (FDA).

A national multi-center study is underway to assess triptan treatment for migraines in adolescents. The study will enroll approximately 450 patients aged 12 to 17 years old with histories of one to 14 migraines per month. The study will run for up to one year and include a screening phase to determine if the patient is eligible for study entry, and an open-label treatment phase. Almotriptan malate 12.5 mg tablets will be used to treat all migraine headaches during the study. The study hypothesis is that almotriptan malate will prove to be safe and well tolerated in the treatment of adolescent migraine headaches. Safety measurements will include laboratory tests, physical and neurological exams, electrocardiograms (ECGs) and the tracking of any adverse reactions. Patients will be asked to keep a diary for each migraine headache for which they take almotriptan malate, tracking triptan use and pain assessment. Equal numbers of patients in the 12 to 14 year-old range and the 15 to 17 year-old range will be enrolled.

Eligibility

To be eligible for the study, patients must:

• have a history of migraine for at least one year
• have an average of one to 14 migraines per month for the 6 months prior to study
• be able to swallow oral medication
• be able to complete a headache diary
• only be taking one migraine preventive medication and have been on the same dose of that medication for at least 30 days before entering the study

Patients are not eligible for study enrollment if they:

• 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 they have a headache
• usually experience migraine aura without a headache (most common symptoms being visual disturbances or tingling sensations before migraine pain begins)
• experience more than six non-migraine headaches per month

For more information or to enroll patients in this study, contact Tonia Sabo, MD, Principal Investigator, or Hazel Senz, RN, Clinical Research Coordinator, at The Children's Hospital at 720-777-1234.