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

Drug Information available for: Dihydroergotamine Dihydroergotamine mesylate

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 Extensions to 26/52 Weeks

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

Primary Outcome Measures:

headache pain relief and associated symptom relief [ Time Frame: 2 hours and other specified timepoints (from 10 minutes to 48 hours). ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

FEV1 DLco ECHO [ Time Frame: up to 6 and up to 12 months of exposure ] [ Designated as safety issue: No ]

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

Arms	Assigned Interventions
1: Experimental Dihydroergotamine Oral Inhalation Aerosol	Drug: MAP0004 Dihydroergotamine Oral Inhalation Aerosol
2: Placebo Comparator	Drug: Placebo Placebo for MAP0004

Detailed Description:

The study will be preseded by a run-inperiod during which eligibility and migraine frequency will be confirmed.

Subjects in Treatment Period 1 (TP1) will be randomized to one of two arms to receive either active drug (MAP0004) or placebo. Subjects will treat one qualifying migraine episode.

Treatment Period 2 is an open label portion of the trial and will last approximately 28 weeks for each subject. All subjects in TP2 will receive active drug (MAP0004).

Treatment Period 3 is also an open label portion of the trial and will last for an additional 24 weeks for each subject.

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 ≥18 and≤ 65 years of age at the time of Visit 1
History of episodic, acute migraine (with or without aura) with onset prior to 50
Stable respiratory status
Stable cardiac status

Major Exclusion Criteria:

History of hemiplegic or basilar migraine
Diagnosis of cancer within the 5 years prior to Visit 1
History of unstable psychiatric illness
Known allergy or sensitivity or contraidication to study drugs or their formulations
Frequent use of opiate analgesics or barbiturates
Pregnancy, breast feeding or planned pregnancy
Clinically significant liver or kidney disease
History of chronic pulmonary disease, coronary artery disease (CAD), coronary vasospasm, aortic aneurysm, peripheral vascular disease or other ischemic diseases
Any history of cerebral vascular accident (CVA), transient ischemic attacks (TIA), or seizures
severe asthma
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: Shashi Kori, MD

clinical@mappharma.com

Locations

United States, California
Investigational Site
San Francisco, California, United States, 94109

Sponsors and Collaborators

MAP Pharmaceuticals, Inc.

Investigators

Study Director:

Shashi Kori, MD

MAP Pharmaceuticals Medical Monitor

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	MAP Pharmaceuticals ( Shashi Kori MD )
Study ID Numbers:	MAP0004 CL P301
Study First Received:	February 7, 2008
Last Updated:	February 25, 2008
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:

Dopamine
Migraine Disorders
Headache
Central Nervous System Diseases

Dihydroergotamine
Headache Disorders, Primary
Brain Diseases
Headache Disorders

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Physiological Effects of Drugs
Cardiovascular Agents
Dopamine Agonists
Pharmacologic Actions
Analgesics, Non-Narcotic

Sensory System Agents
Therapeutic Uses
Vasoconstrictor Agents
Dopamine Agents
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009