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

Primary Purpose

Migraine With Aura, Migraine Without Aura

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Dronabinol MDI
Sponsored by
Solvay Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine With Aura focused on measuring efficacy & safety, migraine headache, placebo-controlled, migraine headache with or without aura

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Site 10
  • Site 8
  • Site 11
  • Site 3
  • Site 6
  • Site 15
  • Site 26
  • Site 22
  • Site 18
  • Site 27
  • Site 14
  • Site 24
  • Site 7
  • Site 25
  • Site 12
  • Site 1
  • Site 28
  • Site 20
  • Site 2
  • Site 19
  • Site 29
  • Site 4
  • Site 9
  • Site 23
  • Site 13
  • Site 5
  • Site 16
  • Site 17
  • Site 21

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 21, 2005
Last Updated
January 15, 2015
Sponsor
Solvay Pharmaceuticals
Collaborators
Nektar Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT00123201
Brief Title
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

2. Study Status

Record Verification Date
September 2006
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
March 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Solvay Pharmaceuticals
Collaborators
Nektar Therapeutics

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine With Aura, Migraine Without Aura
Keywords
efficacy & safety, migraine headache, placebo-controlled, migraine headache with or without aura

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Dronabinol MDI

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Director Solvay
Organizational Affiliation
Solvay Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Site 10
City
Huntsville
State/Province
Alabama
Country
United States
Facility Name
Site 8
City
Huntsville
State/Province
Alabama
Country
United States
Facility Name
Site 11
City
Tucson
State/Province
Arizona
Country
United States
Facility Name
Site 3
City
Anaheim
State/Province
California
Country
United States
Facility Name
Site 6
City
San Fransisco
State/Province
California
Country
United States
Facility Name
Site 15
City
Stockton
State/Province
California
Country
United States
Facility Name
Site 26
City
Melbourne
State/Province
Florida
Country
United States
Facility Name
Site 22
City
New Port Richey
State/Province
Florida
Country
United States
Facility Name
Site 18
City
Orange City
State/Province
Florida
Country
United States
Facility Name
Site 27
City
Pembroke Pines
State/Province
Florida
Country
United States
Facility Name
Site 14
City
Plantation
State/Province
Florida
Country
United States
Facility Name
Site 24
City
Plantation
State/Province
Florida
Country
United States
Facility Name
Site 7
City
St. Petersburg
State/Province
Florida
Country
United States
Facility Name
Site 25
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Site 12
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Site 1
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Site 28
City
Lexington
State/Province
Kentucky
Country
United States
Facility Name
Site 20
City
Madisonville
State/Province
Kentucky
Country
United States
Facility Name
Site 2
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Site 19
City
Omaha
State/Province
Nebraska
Country
United States
Facility Name
Site 29
City
Clementon
State/Province
New Jersey
Country
United States
Facility Name
Site 4
City
Mt. Vernon
State/Province
New York
Country
United States
Facility Name
Site 9
City
Raleigh
State/Province
North Carolina
Country
United States
Facility Name
Site 23
City
Fargo
State/Province
North Dakota
Country
United States
Facility Name
Site 13
City
Portland
State/Province
Oregon
Country
United States
Facility Name
Site 5
City
Spartanburg
State/Province
South Carolina
Country
United States
Facility Name
Site 16
City
Bryan
State/Province
Texas
Country
United States
Facility Name
Site 17
City
Colleyville
State/Province
Texas
Country
United States
Facility Name
Site 21
City
Alexandria
State/Province
Virginia
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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