Overview
Study to Evaluate the Efficacy and Safety of Dronabinol Metered Dose Inhaler (MDI) in Acute Treatment of Migraine Headache
Status:
Completed
Completed
Trial end date:
2007-03-01
2007-03-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Solvay PharmaceuticalsCollaborator:
Nektar TherapeuticsTreatments:
DronabinolCriteria
Inclusion Criteria:- Male or female subjects 18 to 65 years, inclusive, with clinically diagnosed migraine
with or without aura based on International Headache Society criteria
Exclusion Criteria:
- 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.