Phase 3 Study of MAP0004 in Adult Migraineurs - Full Text View

Sponsored by:	MAP Pharmaceuticals, Inc.
Information provided by:	MAP Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00623636

Purpose

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.

Condition	Intervention	Phase
Migraine	Drug: MAP0004 Drug: Placebo	Phase III

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Headache Migraine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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.

Further study details as provided by MAP Pharmaceuticals, Inc.:

Primary Outcome Measures:

headache pain relief and freedom from associated symptoms. [ Time Frame: 2 hours and other specified timepoints. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pain relief in 10 mnts, sustained pain relief 2-24 hours, Long term safety [ Time Frame: up to 12 months of exposure ] [ Designated as safety issue: No ]

Estimated Enrollment:	950
Study Start Date:	July 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental MAP0004	Drug: MAP0004 inhalation for Single attack
2: Placebo Comparator	Drug: Placebo Placebo for MAP0004

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00623636

Contacts

Contact: Shashidhar H Kori, MD

clinical@mappharma.com

Locations

United States, Washington
Swedish Pain and Headache Clinic	Recruiting
Seattle, Washington, United States, 98104
Contact clinical@mappharma.com
Principal Investigator: Sheena Aurora, MD

Sponsors and Collaborators

MAP Pharmaceuticals, Inc.

Investigators

Study Director:

Shashidhar H Kori, MD

MAP Pharmaceuticals Medical Monitor

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	MAP Pharmaceuticals ( Shashidhar H Kori MD )
Study ID Numbers:	MAP0004 CL P301
Study First Received:	February 7, 2008
Last Updated:	February 9, 2009
ClinicalTrials.gov Identifier:	NCT00623636
Health Authority:	United States: Food and Drug Administration

Keywords provided by MAP Pharmaceuticals, Inc.:

Migraine

Study placed in the following topic categories:

Migraine Disorders
Headache
Central Nervous System Diseases

Headache Disorders, Primary
Brain Diseases
Headache Disorders

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on February 12, 2009