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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00123201
First Posted: July 22, 2005
Last Update Posted: January 16, 2015
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.
Collaborator:
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 With Aura Migraine Without Aura Drug: Dronabinol MDI Phase 2

Study Type: Interventional
Study Design: 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

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)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (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
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


  Show 29 Study Locations
Sponsors and Collaborators
Solvay Pharmaceuticals
Nektar Therapeutics
Investigators
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
  More Information

ClinicalTrials.gov Identifier: NCT00123201     History of Changes
Other Study ID Numbers: S175.2.103
First Submitted: July 21, 2005
First Posted: July 22, 2005
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:
Migraine Disorders
Headache
Migraine with Aura
Migraine without Aura
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
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