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

NCT00210483 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 866

Last updated 2011-05-17

No results posted yet for this 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.

Conditions

Interventions

DRUG

almotriptan malate

Sponsors & Collaborators

  • Ortho-McNeil Neurologics, Inc.

    collaborator INDUSTRY

  • Janssen-Ortho LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Ortho LLC Clinical Trial · Janssen-Ortho LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-07-31
Completion
2005-07-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00210483 on ClinicalTrials.gov