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

Condition(s) targeted: Migraine With Aura; Migraine Without Aura

Intervention: Dronabinol MDI (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Solvay Pharmaceuticals

Official(s) and/or principal investigator(s):
Global Clinical Director Solvay, Study Director, Affiliation: Solvay Pharmaceuticals

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.

Official title: A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Efficacy, Safety and Tolerability Study of Dronabinol MDI in the Acute Treatment of Migraine Headache

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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.

Site 8, Huntsville, Alabama, United States

Site 10, 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 7, St. Petersburg, Florida, United States

Site 14, Plantation, Florida, United States

Site 18, Orange City, Florida, United States

Site 22, New Port Richey, Florida, United States

Site 24, Plantation, Florida, United States

Site 26, Melbourne, Florida, United States

Site 27, Pembroke Pines, Florida, United States

Site 25, Atlanta, Georgia, United States

Site 1, Chicago, Illinois, United States

Site 12, Chicago, Illinois, United States

Site 20, Madisonville, Kentucky, United States

Site 28, Lexington, Kentucky, United States

Site 2, Boston, Massachusetts, United States

Site 19, Omaha, Nebraska, United States

Site 29, Clementon, New Jersey, United States

Site 4, Mt. 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

Starting date: September 2005
Last updated: September 7, 2006