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

This study has been completed.
Nektar Therapeutics
Information provided by:
Solvay Pharmaceuticals Identifier:
First received: July 21, 2005
Last updated: January 15, 2015
Last verified: September 2006
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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

Further study details as provided by Solvay Pharmaceuticals:

Study Start Date: September 2005
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)

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

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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Please refer to this study by its identifier: NCT00123201

  Show 29 Study Locations
Sponsors and Collaborators
Solvay Pharmaceuticals
Nektar Therapeutics
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
  More Information Identifier: NCT00123201     History of Changes
Other Study ID Numbers: S175.2.103 
Study First Received: July 21, 2005
Last Updated: January 15, 2015
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:
Migraine Disorders
Migraine with Aura
Migraine without Aura
Brain Diseases
Central Nervous System Diseases
Headache Disorders
Headache Disorders, Primary
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Analgesics, Non-Narcotic
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents processed this record on May 26, 2016