NCT00210483

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
866

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jul 2003

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
Last Updated

May 17, 2011

Status Verified

April 1, 2010

First QC Date

September 13, 2005

Last Update Submit

May 16, 2011

Conditions

Migraine

Keywords

painMigraineauraheadache

Outcome Measures

Primary Outcomes (1)

  • Efficacy determined by patient 2 hours after dosing by rating of headache intensity as a decrease from moderate or severe to mild or no pain

Secondary Outcomes (1)

  • Efficacy, symptoms, headache pain free at time points 0.25, 0.5, 1, 1.5 hours postdose; incidence of headache recurrence in 2 to 24 hours and use of rescue medication 2 to 24 hours postdose; pain relief or pain free at 24 hours; all by patient assessment

Interventions

almotriptan malateDRUG

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Linder SL, Mathew NT, Cady RK, Finlayson G, Ishkanian G, Lewis DW. Efficacy and tolerability of almotriptan in adolescents: a randomized, double-blind, placebo-controlled trial. Headache. 2008 Oct;48(9):1326-36. doi: 10.1111/j.1526-4610.2008.01138.x. Epub 2008 May 14.

    PMID: 18484981DERIVED

Related Links

MeSH Terms

Conditions

Migraine DisordersPainEpilepsyHeadache

Interventions

almotriptan

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Janssen Ortho LLC Clinical Trial

    Janssen-Ortho LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

July 1, 2003

Study Completion

July 1, 2005

Last Updated

May 17, 2011

Record last verified: 2010-04