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

Sponsor:	Solvay Pharmaceuticals
Collaborator:	Nektar Therapeutics
Information provided by:	Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00123201

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 With Aura Migraine Without Aura	Drug: Dronabinol MDI	Phase II

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

Resource links provided by NLM:

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Headache Migraine

Drug Information available for: Tetrahydrocannabinol

U.S. FDA Resources

Further study details as provided by Solvay Pharmaceuticals:

Study Start Date:

September 2005

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00123201

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Locations

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

Sponsors and Collaborators

Solvay Pharmaceuticals

Nektar Therapeutics

Investigators

Study Director:

Global Clinical Director Solvay

Solvay Pharmaceuticals

More Information

No publications provided

Study ID Numbers:	S175.2.103
Study First Received:	July 21, 2005
Last Updated:	September 7, 2006
ClinicalTrials.gov Identifier:	NCT00123201 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Solvay Pharmaceuticals:

efficacy & safety, migraine headache, placebo-controlled
migraine headache with or without aura

Additional relevant MeSH terms:

Physiological Effects of Drugs
Nervous System Diseases
Psychotropic Drugs
Hallucinogens
Central Nervous System Diseases
Pain
Headache Disorders, Primary
Brain Diseases
Pharmacologic Actions
Headache Disorders
Tetrahydrocannabinol
Signs and Symptoms

Sensory System Agents
Analgesics, Non-Narcotic
Migraine Disorders
Therapeutic Uses
Headache
Neurologic Manifestations
Migraine with Aura
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Migraine without Aura

ClinicalTrials.gov processed this record on November 30, 2009