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Sponsored by: |
MAP Pharmaceuticals, Inc. |
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Information provided by: | MAP Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00623636 |
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 |
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 |
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 |
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1: Experimental
Dihydroergotamine Oral Inhalation Aerosol
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Drug: MAP0004
Dihydroergotamine Oral Inhalation Aerosol
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2: Placebo Comparator |
Drug: Placebo
Placebo for MAP0004
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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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Major Inclusion Criteria:
Major Exclusion Criteria:
Contact: Shashi Kori, MD | clinical@mappharma.com |
United States, California | |
Investigational Site | |
San Francisco, California, United States, 94109 |
Study Director: | Shashi Kori, MD | MAP Pharmaceuticals Medical Monitor |
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 |
Migraine |
Dopamine Migraine Disorders Headache Central Nervous System Diseases |
Dihydroergotamine Headache Disorders, Primary Brain Diseases Headache Disorders |
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 |