Phase 3 N=902 Randomized Quadruple-blind Treatment

Phase 3 Study of MAP0004 in Adult Migraineurs

Migraine Disorders

Bottom Line

View on ClinicalTrials.gov: NCT00623636 ↗

Enrolled (actual)

902

Serious AEs

1.0%

Results posted

Oct 2013

Primary outcome: Primary: Number of Subjects With Pain Relief at 2 Hours From Time of First Dose — 136; 231 participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: MAP0004 (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Allergan
Primary completion: Dec 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Subjects With Pain Relief at 2 Hours From Time of First Dose	136; 231	—
PRIMARY Number of Subjects Photophobia Free at 2 Hours From Time of First Dose	107; 182	—
PRIMARY Number of Subjects Phonophobia Free at 2 Hours From Time of First Dose	133; 208	—
PRIMARY Number of Subjects Nausea Free at 2 Hours From Time of First Dose	234; 266	—
SECONDARY Number of Subjects With Sustained Pain Relief From 2 to 24 Hours	76; 166	—
SECONDARY Number of Subjects Whose Time to Pain Relief Occurred Within 2 Hours	156; 244	—
SECONDARY Number of Subjects With Pain Relief at 4 Hours	145; 254	—
SECONDARY Number of Subjects With Pain Relief at 10 Minutes	30; 37	—

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.

Eligibility Criteria

Major Inclusion Criteria:

Male or female between 18 and 65 years of age.
History of episodic, acute migraine (with or without aura) with onset prior to 50

Major Exclusion Criteria:

Known allergy or sensitivity or contraindication to study drugs or their formulations
History of chronic pulmonary disease, coronary artery disease (CAD), liver disease, kidney disease, seizures, stroke, or major psychiatric condition.
Any condition that, in the opinion of the Investigator, would make the subject unsuitable for study participation

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00623636). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.