Study to Evaluate the Efficacy and Safety of Dronabinol Metered Dose Inhaler (MDI) in Acute Treatment of Migraine Headache
A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Efficacy, Safety and Tolerability Study of Dronabinol MDI in the Acute Treatment of Migraine Headache
1 other identifier
interventional
N/A
1 country
29
Brief Summary
The primary objective of this study is to evaluate the efficacy and safety of dronabinol MDI for the acute treatment of moderate to severe migraine headache.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Sep 2005
Shorter than P25 for phase_2
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 21, 2005
CompletedFirst Posted
Study publicly available on registry
July 22, 2005
CompletedStudy Start
First participant enrolled
September 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2007
CompletedJanuary 16, 2015
September 1, 2006
1.5 years
July 21, 2005
January 15, 2015
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Male or female subjects 18 to 65 years, inclusive, with clinically diagnosed migraine with or without aura based on International Headache Society criteria
You may not qualify if:
- Subjects who experience migraine with prolonged aura; familiar hemiplegic migraine; migrainous infarction or basilar migraine; and those with greater than eight migraine attacks per month and/or greater than 14 migraine days per month.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Solvay Pharmaceuticalslead
- Nektar Therapeuticscollaborator
Study Sites (29)
Site 10
Huntsville, Alabama, United States
Site 8
Huntsville, Alabama, United States
Site 11
Tucson, Arizona, United States
Site 3
Anaheim, California, United States
Site 6
San Francisco, California, United States
Site 15
Stockton, California, United States
Site 26
Melbourne, Florida, United States
Site 22
New Port Richey, Florida, United States
Site 18
Orange City, Florida, United States
Site 27
Pembroke Pines, Florida, United States
Site 14
Plantation, Florida, United States
Site 24
Plantation, Florida, United States
Site 7
St. Petersburg, Florida, United States
Site 25
Atlanta, Georgia, United States
Site 12
Chicago, Illinois, United States
Site 1
Chicago, Illinois, United States
Site 28
Lexington, Kentucky, United States
Site 20
Madisonville, Kentucky, United States
Site 2
Boston, Massachusetts, United States
Site 19
Omaha, Nebraska, United States
Site 29
Clementon, New Jersey, United States
Site 4
Mount Vernon, New York, United States
Site 9
Raleigh, North Carolina, United States
Site 23
Fargo, North Dakota, United States
Site 13
Portland, Oregon, United States
Site 5
Spartanburg, South Carolina, United States
Site 16
Bryan, Texas, United States
Site 17
Colleyville, Texas, United States
Site 21
Alexandria, Virginia, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Director Solvay
Solvay Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 21, 2005
First Posted
July 22, 2005
Study Start
September 1, 2005
Primary Completion
March 1, 2007
Study Completion
March 1, 2007
Last Updated
January 16, 2015
Record last verified: 2006-09