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

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 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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.

Resource links provided by NLM:

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Headache Migraine

U.S. FDA Resources

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 ]

Enrollment:	1195
Study Start Date:	July 2008
Study Completion Date:	January 2011
Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Double Blind MAP0004 or Placebo - the double blind portion of the study is completed and not recruiting	Drug: MAP0004 inhalation for Single attack Other Name: MAP0004 Drug: Placebo Placebo for MAP0004 Other Name: Placebo
Experimental: Open Label MAP0004 - this arm is active but not recruiting	Drug: MAP0004 inhalation for Single attack Other Name: MAP0004
Experimental: Open Label - Asthmatics MAP0004 - this arm is active but not recruiting	Drug: MAP0004 inhalation for Single attack Other Name: MAP0004
No Intervention: Control Group This arm is active but no longer recruiting

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

Locations

United States, Washington
Swedish Pain and Headache Clinic
Seattle, Washington, United States, 98104

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 by MAP Pharmaceuticals, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

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.

Responsible Party:	Shashidhar H Kori MD, MAP Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00623636 History of Changes
Other Study ID Numbers:	MAP0004 CL P301
Study First Received:	February 7, 2008
Last Updated:	February 17, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by MAP Pharmaceuticals, Inc.:

Migraine

Additional relevant MeSH terms:

Migraine Disorders
Headache Disorders, Primary
Headache Disorders

Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 21, 2013

Phase 3 Study of MAP0004 in Adult Migraineurs (FREEDOM301)