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

Last updated: May 16, 2011
Sponsor: Janssen-Ortho LLC
Overall Status: Completed

Phase

3

Condition

Pain (Pediatric)

Chronic Pain

Headaches

Treatment

N/A

Clinical Study ID

NCT00210483
CR004567
  • Ages 12-17
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 enteringthe 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

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 antimigrainemedication 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 likealmotriptan within 48 hours before and 24 hours after taking study medication, ordrugs containing opiates or antivomiting medicine within 48 hours before and 2 hoursafter taking study medication

  • Use of simple pain medicines within 24 hours (like aspirin)

Study Design

Total Participants: 866
Study Start date:
July 01, 2003
Estimated Completion Date:
July 31, 2005

Study Description

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 30-day run-in period, patients will treat their migraines as they normally would. During this time, the frequency and severity of headaches will be recorded. At the second visit, patients will be randomized (like with the toss of a coin) to a treatment group to receive one oral dose of almotriptan malate (AXERT®) 6.25, 12.5, or 25 milligrams or placebo. Approximately the same number of patients will be assigned to each of the four treatment groups. Patients will take this one-time dose when the next migraine of at least moderate severity occurs. Patients will record assessments in a diary for up to 24 hours after the study drug is given to help determine the drug's effect on headache pain intensity. Patients will return for a third visit within 2 to 14 days from taking the study medication. A physical examination, electrocardiogram (a painless test of the heart), and laboratory tests will be performed at the first and third visits. The objective of this study is to determine the effectiveness and tolerability of 3 dosage strengths of almotriptan malate (AXERT®) in adolescents with migraine headaches.

Almotriptan oral tablets, 6.25, 12.5, or 25 milligrams, or placebo