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.

Condition	Intervention	Phase
migraine headache with or without aura	Drug: Dronabinol MDI	Phase II

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  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.

Please refer to this study by ClinicalTrials.gov identifier  NCT00123201

Christopher West       christopher.west@quintiles.com

Alabama
      Site 8, Huntsville,  Alabama,  United States
      Site 10, Huntsville,  Alabama,  United States
Arizona
      Site 11, Tucson,  Arizona,  United States
California
      Site 3, Anaheim,  California,  United States
      Site 6, San Fransisco,  California,  United States
      Site 15, Stockton,  California,  United States
Florida
      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, Pembrook Pines,  Florida,  United States
Georgia
      Site 25, Atlanta,  Georgia,  United States
Illinois
      Site 1, Chicago,  Illinois,  United States
      Site 12, Chicago,  Illinois,  United States
Kentucky
      Site 20, Madisonville,  Kentucky,  United States
      Site 28, Lexington,  Kentucky,  United States
Massachusetts
      Site 2, Boston,  Massachusetts,  United States
Nebraska
      Site 19, Omaha,  Nebraska,  United States
New Jersey
      Site 29, Clementon,  New Jersey,  United States
New York
      Site 4, Mt. Vernon,  New York,  United States
North Carolina
      Site 9, Raleigh,  North Carolina,  United States
North Dakota
      Site 23, Fargo,  North Dakota,  United States
Oregon
      Site 13, Portland,  Oregon,  United States
South Carolina
      Site 5, Spartanburg,  South Carolina,  United States
Texas
      Site 16, Bryan,  Texas,  United States
      Site 17, Colleyville,  Texas,  United States
Virginia
      Site 21, Alexandria,  Virginia,  United States

Study chairs or principal investigators

Christopher West,  Study Director,  Quintiles QRTP   

Study ID Numbers:  S175.2.103
Record last reviewed:  July 2005
Last Updated:  July 25, 2005
Record first received:  July 21, 2005
ClinicalTrials.gov Identifier:  NCT00123201
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-07-26