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: January 15, 2015

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:

Genetics Home Reference related topics: familial hemiplegic migraine sporadic hemiplegic migraine

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

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:	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 Dronabinol Analgesics Analgesics, Non-Narcotic Cannabinoid Receptor Agonists Cannabinoid Receptor Modulators	Central Nervous System Agents Hallucinogens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Psychotropic Drugs Sensory System Agents Therapeutic Uses

ClinicalTrials.gov processed this record on March 01, 2015

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