Migraine Without Aura Clinical Trial
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
| Verified date | September 2006 |
| Source | Solvay Pharmaceuticals |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 0 |
| Est. completion date | March 2007 |
| Est. primary completion date | March 2007 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Site 21 | Alexandria | Virginia |
| United States | Site 3 | Anaheim | California |
| United States | Site 25 | Atlanta | Georgia |
| United States | Site 2 | Boston | Massachusetts |
| United States | Site 16 | Bryan | Texas |
| United States | Site 1 | Chicago | Illinois |
| United States | Site 12 | Chicago | Illinois |
| United States | Site 29 | Clementon | New Jersey |
| United States | Site 17 | Colleyville | Texas |
| United States | Site 23 | Fargo | North Dakota |
| United States | Site 10 | Huntsville | Alabama |
| United States | Site 8 | Huntsville | Alabama |
| United States | Site 28 | Lexington | Kentucky |
| United States | Site 20 | Madisonville | Kentucky |
| United States | Site 26 | Melbourne | Florida |
| United States | Site 4 | Mt. Vernon | New York |
| United States | Site 22 | New Port Richey | Florida |
| United States | Site 19 | Omaha | Nebraska |
| United States | Site 18 | Orange City | Florida |
| United States | Site 27 | Pembroke Pines | Florida |
| United States | Site 14 | Plantation | Florida |
| United States | Site 24 | Plantation | Florida |
| United States | Site 13 | Portland | Oregon |
| United States | Site 9 | Raleigh | North Carolina |
| United States | Site 6 | San Fransisco | California |
| United States | Site 5 | Spartanburg | South Carolina |
| United States | Site 7 | St. Petersburg | Florida |
| United States | Site 15 | Stockton | California |
| United States | Site 11 | Tucson | Arizona |
| Lead Sponsor | Collaborator |
|---|---|
| Solvay Pharmaceuticals | Nektar Therapeutics |
United States,
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