Clinical trial NCT00623636: Phase 3 Study of MAP0004 in Adult Migraineurs
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine Disorders
Keywords: Migraine
Lead sponsor: Allergan
Sponsor class: INDUSTRY
Collaborators: name: MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
First posted: 2008-02-26
Enrollment: 902
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Number of Subjects With Pain Relief at 2 Hours From Time of First Dose
timeFrame: 2 hours from time of first dose
measure: Number of Subjects Photophobia Free at 2 Hours From Time of First Dose
timeFrame: 2 hours from time of first dose
measure: Number of Subjects Phonophobia Free at 2 Hours From Time of First Dose
timeFrame: 2 hours from time of first dose
measure: Number of Subjects Nausea Free at 2 Hours From Time of First Dose
timeFrame: 2 hours from time of first dose
Secondary outcomes:
measure: Number of Subjects With Sustained Pain Relief From 2 to 24 Hours
timeFrame: From 2 to 24 hours from time of first dose
measure: Number of Subjects Whose Time to Pain Relief Occurred Within 2 Hours
timeFrame: 2 hours from the first dose
measure: Number of Subjects With Pain Relief at 4 Hours
timeFrame: 4 hours from time of first dose
measure: Number of Subjects With Pain Relief at 10 Minutes
timeFrame: 2 hours from time of first dose
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Swedish Pain and Headache Clinic
state: Washington
Study officials:
affiliation: MAP Pharmaceuticals a Wholly Owned Subsidiary of Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Tepper SJ, Kori SH, Borland SW, Wang MH, Hu B, Mathew NT, Silberstein SD. Efficacy and safety of MAP0004, orally inhaled DHE in treating migraines with and without allodynia. Headache. 2012 Jan;52(1):37-47. doi: 10.1111/j.1526-4610.2011.02041.x. Epub 2011 Nov 22.
citation: Tepper SJ, Kori SH, Goadsby PJ, Winner PK, Wang MH, Silberstein SD, Cutrer FM. MAP0004, orally inhaled dihydroergotamine for acute treatment of migraine: efficacy of early and late treatments. Mayo Clin Proc. 2011 Oct;86(10):948-55. doi: 10.4065/mcp.2011.0093.
citation: Aurora SK, Silberstein SD, Kori SH, Tepper SJ, Borland SW, Wang M, Dodick DW. MAP0004, orally inhaled DHE: a randomized, controlled study in the acute treatment of migraine. Headache. 2011 Apr;51(4):507-17. doi: 10.1111/j.1526-4610.2011.01869.x.