CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 902 enrolled
Drug / intervention
MAP0004 +1 moredrug
Likely dose
MAP0004 1.0mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00623636
NCT00623636Phase 3Completed
CompareCT.gov

A Randomized, Double Blind, Placebo Controlled, Parallel Group, Phase 3 Study of MAP0004 in Adult Migraineurs for a Single Migraine Followed by Open Label Extension.

Allergan·interventional·Posted Feb 26, 2008·Updated Jan 9, 2014

In Brief

A Phase 3 clinical trial evaluating MAP0004 and Placebo for Migraine Disorders. Completed, enrolled 902 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMigraine Disorders
CountriesUnited States
CollaboratorsMAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 26, 2008
Enrollment StartJul 1, 2008
Primary CompletionDec 1, 2010
Study CompletionJan 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 18.3 years ago

Interventions

MAP0004drug

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.

Placebodrug

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