Status:
COMPLETED
Study to Evaluate the Efficacy and Safety of Dronabinol Metered Dose Inhaler (MDI) in Acute Treatment of Migraine Headache
Lead Sponsor:
Solvay Pharmaceuticals
Collaborating Sponsors:
Nektar Therapeutics
Conditions:
Migraine With Aura
Migraine Without Aura
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- Male or female subjects 18 to 65 years, inclusive, with clinically diagnosed migraine with or without aura based on International Headache Society criteria
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
End Date :
March 1 2007
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00123201
Start Date
September 1 2005
End Date
March 1 2007
Last Update
January 16 2015
Active Locations (29)
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1
Site 10
Huntsville, Alabama, United States
2
Site 8
Huntsville, Alabama, United States
3
Site 11
Tucson, Arizona, United States
4
Site 3
Anaheim, California, United States