Study to Evaluate the Efficacy and Safety of Dronabinol Metered Dose Inhaler (MDI) in Acute Treatment of Migraine Headache
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ClinicalTrials.gov Identifier: NCT00123201 |
Recruitment Status :
Completed
First Posted : July 22, 2005
Last Update Posted : January 16, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Migraine With Aura Migraine Without Aura | Drug: Dronabinol MDI | Phase 2 |
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 |


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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 |
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.

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

Study Director: | Global Clinical Director Solvay | Solvay Pharmaceuticals |
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 |
efficacy & safety, migraine headache, placebo-controlled migraine headache with or without aura |
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 |