Clinical trial NCT00123201: Study to Evaluate the Efficacy and Safety of Dronabinol Metered Dose Inhaler (MDI) in Acute Treatment of Migraine Headache
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Migraine With Aura
Migraine Without Aura
Keywords: efficacy & safety, migraine headache, placebo-controlled
migraine headache with or without aura
Lead sponsor: Solvay Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Nektar Therapeutics
First posted: 2005-07-22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Site 10
state: Alabama
city: Huntsville
country: United States
facility: Site 8
state: Alabama
city: Tucson
country: United States
facility: Site 11
state: Arizona
city: Anaheim
country: United States
facility: Site 3
state: California
city: San Fransisco
country: United States
facility: Site 6
state: California
city: Stockton
country: United States
facility: Site 15
state: California
city: Melbourne
country: United States
facility: Site 26
state: Florida
city: New Port Richey
country: United States
facility: Site 22
state: Florida
city: Orange City
country: United States
facility: Site 18
state: Florida
city: Pembroke Pines
country: United States
facility: Site 27
state: Florida
city: Plantation
country: United States
facility: Site 14
state: Florida
city: Plantation
country: United States
facility: Site 24
state: Florida
city: St. Petersburg
country: United States
facility: Site 7
state: Florida
city: Atlanta
country: United States
facility: Site 25
state: Georgia
city: Chicago
country: United States
facility: Site 12
state: Illinois
city: Chicago
country: United States
facility: Site 1
state: Illinois
city: Lexington
country: United States
facility: Site 28
state: Kentucky
city: Madisonville
country: United States
facility: Site 20
state: Kentucky
city: Boston
country: United States
facility: Site 2
state: Massachusetts
city: Omaha
country: United States
facility: Site 19
state: Nebraska
city: Clementon
country: United States
facility: Site 29
state: New Jersey
city: Mt. Vernon
country: United States
facility: Site 4
state: New York
city: Raleigh
country: United States
facility: Site 9
state: North Carolina
city: Fargo
country: United States
facility: Site 23
state: North Dakota
city: Portland
country: United States
facility: Site 13
state: Oregon
city: Spartanburg
country: United States
facility: Site 5
state: South Carolina
city: Bryan
country: United States
facility: Site 16
state: Texas
city: Colleyville
country: United States
facility: Site 17
state: Texas
city: Alexandria
country: United States
facility: Site 21
state: Virginia
Study officials:
affiliation: Solvay Pharmaceuticals
name: Global Clinical Director Solvay
role: STUDY_DIRECTOR
References: