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

• Status: Completed
• Trial end date: 2005-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effectiveness and safety of almotriptan malate (AXERT®) in treating acute migraine headaches in adolescents. Amotriptan malate (AXERT®) is approved for use in the treatment of acute migraine headache with or without aura in adults. In this study, adolescents will be given a single dose of study medication to treat one migraine headache.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen-Ortho LLC
• Collaborator: Ortho-McNeil Neurologics, Inc.
• Treatments: Almotriptan

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)