Phase 3 Study of MAP0004 in Adult Migraineurs
Information source: MAP Pharmaceuticals, Inc.
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Migraine
Intervention: MAP0004 (Drug); Placebo (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: MAP Pharmaceuticals, Inc. Official(s) and/or principal investigator(s):
Shashi Kori, MD, Study Director, Affiliation: MAP Pharmaceuticals Medical Monitor
Overall contact:
Shashi Kori, MD, Email: clinical@mappharma.com
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.
Clinical Details
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
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: headache pain relief and associated symptom relief
Secondary outcome: FEV1 DLco ECHO
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
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Shashi Kori, MD, Email: clinical@mappharma.com
Investigational Site, San Francisco, California 94109, United States
Additional Information
Starting date: March 2008
Ending date: September 2009
Last updated: February 25, 2008
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