Clinical Trial: Study to Evaluate the Efficacy and Safety of Dronabinol MDI in Acute Treatment of Migraine Headache

This study is not yet open for patient recruitment.

Sponsors and Collaborators: Solvay Pharmaceuticals
Nektar Therapeutics
Information provided by: Solvay Pharmaceuticals

Purpose

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

MedlinePlus consumer health information 

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

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.

Eligibility

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.

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00123201

Christopher West       christopher.west@quintiles.com

Alabama
      Site 8, Huntsville,  Alabama,  United States
Christopher West   christopher.west@quintiles.com 

      Site 10, Huntsville,  Alabama,  United States
Christopher West   christopher.west@quintiles.com 

Arizona
      Site 11, Tucson,  Arizona,  United States
Christopher West   christopher.west@quintiles.com 

California
      Site 3, Anaheim,  California,  United States
Christopher West   christopher.west@quintiles.com 

      Site 6, San Fransisco,  California,  United States
Christopher West   christopher.west@quintiles.com 

      Site 15, Stockton,  California,  United States
Christopher West   christopher.west@quintiles.com 

Florida
      Site 7, St. Petersburg,  Florida,  United States
Christopher West   christopher.west@quintiles.com 

      Site 14, Plantation,  Florida,  United States
Christopher West   christopher.west@quintiles.com 

      Site 18, Orange City,  Florida,  United States

      Site 22, New Port Richey,  Florida,  United States
Christopher West   christopher.west@quintiles.com 

      Site 24, Plantation,  Florida,  United States
Christopher West   christopher.west@quintiles.com 

      Site 26, Melbourne,  Florida,  United States
Christopher West   christopher.west@quintiles.com 

      Site 27, Pembrook Pines,  Florida,  United States
Christopher West   christopher.west@quintiles.com 

Georgia
      Site 25, Atlanta,  Georgia,  United States
Christopher West   christopher.west@quintiles.com 

Illinois
      Site 1, Chicago,  Illinois,  United States
Christopher West   christopher.west@quintiles.com 

      Site 12, Chicago,  Illinois,  United States
Christopher West   christopher.west@quintiles.com 

Kentucky
      Site 20, Madisonville,  Kentucky,  United States
Christopher West   christopher.west@quintiles.com 

      Site 28, Lexington,  Kentucky,  United States
Christopher West   christopher.west@quintiles.com 

Massachusetts
      Site 2, Boston,  Massachusetts,  United States
Christopher West   christopher.west@quintiles.com 

Nebraska
      Site 19, Omaha,  Nebraska,  United States
Christopher West   christopher.west@quintiles.com 

New Jersey
      Site 29, Clementon,  New Jersey,  United States
Christopher West   christopher.west@quintiles.com 

New York
      Site 4, Mt. Vernon,  New York,  United States
Christopher West   christopher.west@quintiles.com 

North Carolina
      Site 9, Raleigh,  North Carolina,  United States
Christopher West   christopher.west@quintiles.com 

North Dakota
      Site 23, Fargo,  North Dakota,  United States
Christopher West   christopher.west@quintiles.com 

Oregon
      Site 13, Portland,  Oregon,  United States
Christopher West   christopher.west@quintiles.com 

South Carolina
      Site 5, Spartanburg,  South Carolina,  United States
Christopher West   christopher.west@quintiles.com 

Texas
      Site 16, Bryan,  Texas,  United States
Christopher West   christopher.west@quintiles.com 

      Site 17, Colleyville,  Texas,  United States
Christopher West   christopher.west@quintiles.com 

Virginia
      Site 21, Alexandria,  Virginia,  United States
Christopher West   christopher.west@quintiles.com 

Study chairs or principal investigators

Christopher West,  Study Director,  Quintiles QRTP   

More Information

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

Resources




Common Treatments

[ Disclaimer: The information on GoldBamboo for any particular treatment, medicine, drug, or herbal product might be missing or incomplete, and should never be used as a single source of knowledge. GoldBamboo generally has links to authoritative sites displayed toward the bottom of each topic page under the heading "Resources". ]

Follow Us