A Study of 3 Dosage Strengths of Almotriptan Malate (AXERT®) in the Treatment of Acute Migraine in Adolescents

Launched by JANSSEN-ORTHO LLC · Sep 13, 2005

Keywords

ClinConnect Summary

Amotriptan malate (AXERT®) is approved for use in the treatment of acute migraine headache with or without aura in adults. Other studies have shown that almotriptan is effective and well tolerated in adults. Migraines in teenagers/adolescents are very similar to migraines in adults, except that the duration is usually less in adolescents (they last 1 to 24 hours in adolescents). This study will evaluate the usefulness of almotriptan malate (AXERT®) in treating acute migraine headaches in adolescents. This is a randomized, double-blind, parallel-group, and placebo-controlled study. During a ...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Diagnosis of migraine with or without aura for \> 1 year
• • Average of 1 to 6 moderate or severe migraines per month for 2 months before entering the study
• • Untreated migraines lasting at least 4 hours
• • At least 24 hours between migraines
• • Able to tell the difference between migraines and other types of headache
• • If female, using birth control
• Exclusion Criteria:
• • Chronic tension or cluster headache
• • Prolonged aura
• • Specific types of migraine
• • \> 6 nonmigraine headaches per month
• • High blood pressure for the age
• • Medical history with specific significant conditions affecting the liver, kidney, heart or other body systems
• • Conditions that might affect the way the body absorbs or processes a drug
• • Positive blood tests for Hepatitis B or C
• • Recent head or neck injury
• • Body weight outside given parameters
• • Unable to take sumatriptan
• • Abusing drugs or alcohol
• • Pregnant or breast-feeding
• • Use of antimigraine medication that might interfere with the study, of antimigraine medication for \< 2 weeks, of lithium or monoamine oxidase inhibitors in past 2 weeks, of an investigational drug within 2 months
• • Refuse to abstain from taking medicine with ergotamine or any other drug like almotriptan within 48 hours before and 24 hours after taking study medication, or drugs containing opiates or antivomiting medicine within 48 hours before and 2 hours after taking study medication
• • Use of simple pain medicines within 24 hours (like aspirin)