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Phase 3 Study of MAP0004 in Adult Migraineurs

NCT00623636 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 902

Last updated 2014-01-09

Study results available
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Summary

This is a randomized, double blind, placebo controlled, parallel group study of MAP0004 in adult migraineurs. Subjects will self administer study drug in the outpatient setting.

Conditions

  • Migraine Disorders

Interventions

DRUG

MAP0004

MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks. Placebo treated patients will receive MAP0004 1.0mg inhaled to treat qualifying migraines for up to 52 weeks only.

DRUG

Placebo

Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks.

Sponsors & Collaborators

  • MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan

    collaborator INDUSTRY

  • Allergan

    lead INDUSTRY

Principal Investigators

  • Medical Director · MAP Pharmaceuticals a Wholly Owned Subsidiary of Allergan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2010-12-31
Completion
2011-01-31

Countries

  • United States

Study Locations

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Entities

Drugs

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 NCT00623636 on ClinicalTrials.gov