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Study to Evaluate the Efficacy and Safety of Dronabinol Metered Dose Inhaler (MDI) in Acute Treatment of Migraine Headache

Phase 2
Completed
Conditions
Migraine With Aura
Migraine Without Aura
Registration Number
NCT00123201
Lead Sponsor
Solvay Pharmaceuticals
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
Not specified
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (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 Fransisco, 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

Scroll for more (19 remaining)
Site 10
🇺🇸Huntsville, Alabama, United States

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