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

Solvay

Status and phase: Completed; Phase 2

Conditions: Migraine With Aura; Migraine Without Aura

Treatments: Drug: Dronabinol MDI

Study type: Interventional

Funder types: Industry

Identifiers

NCT00123201

S175.2.103

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind