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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00123201
Recruitment Status : Completed
First Posted : July 22, 2005
Last Update Posted : January 16, 2015
Sponsor:
Collaborator:
Nektar Therapeutics
Information provided by:
Solvay Pharmaceuticals

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Migraine With Aura Migraine Without Aura Drug: Dronabinol MDI Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : September 2005
Actual Primary Completion Date : March 2007
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine
Drug Information available for: Dronabinol

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00123201


Locations
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Sponsors and Collaborators
Solvay Pharmaceuticals
Nektar Therapeutics
Investigators
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Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
More Information
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ClinicalTrials.gov Identifier: NCT00123201    
Other Study ID Numbers: S175.2.103
First Posted: July 22, 2005    Key Record Dates
Last Update Posted: January 16, 2015
Last Verified: September 2006
Keywords provided by Solvay Pharmaceuticals:
efficacy & safety, migraine headache, placebo-controlled
migraine headache with or without aura
Additional relevant MeSH terms:
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Migraine Disorders
Migraine without Aura
Migraine with Aura
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Dronabinol
Hallucinogens
 Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists