Phase 3 Study of MAP0004 in Adult Migraineurs (FREEDOM301)

Allergan

Status and phase: Completed; Phase 3

Conditions: Migraine Disorders

Treatments: Drug: MAP0004; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00623636

MAP0004 CL P301

Details and patient eligibility

About

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.

Enrollment: 902 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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902 participants in 2 patient groups

MAP0004

Experimental group

Description:

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.

Treatment:

Drug: MAP0004

Placebo

Other group

Description:

Placebo 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 52 weeks.

Treatment:

Drug: Placebo

Drug: MAP0004