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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:
Collaborator:
Nektar Therapeutics
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00123201
First received: July 21, 2005
Last updated: September 7, 2006
Last verified: September 2006
History of Changes
  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
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:

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

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

No publications provided

ClinicalTrials.gov Identifier: NCT00123201     History of Changes
Other Study ID Numbers: S175.2.103
Study First Received: July 21, 2005
Last Updated: September 7, 2006
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:
Headache
Migraine Disorders
Migraine with Aura
Migraine without Aura
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
 Tetrahydrocannabinol
Hallucinogens
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on May 23, 2013