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

Completed · Phase 2

Conditions studied: Migraine With Aura, Migraine Without Aura

In brief

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.

Key facts

Study ID

NCT00123201

Run by

Solvay Pharmaceuticals

Starts

2005-09-01

Expected to finish

2007-03-01

Last updated by the study team

2015-01-16

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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