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

January 15, 2015 updated by: Solvay Pharmaceuticals

A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Efficacy, Safety and Tolerability Study of Dronabinol MDI in the Acute Treatment of Migraine Headache

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Huntsville, Alabama, United States
        • Site 10
      • Huntsville, Alabama, United States
        • Site 8
    • Arizona
      • Tucson, Arizona, United States
        • Site 11
    • California
      • Anaheim, California, United States
        • Site 3
      • San Fransisco, California, United States
        • Site 6
      • Stockton, California, United States
        • Site 15
    • Florida
      • Melbourne, Florida, United States
        • Site 26
      • New Port Richey, Florida, United States
        • Site 22
      • Orange City, Florida, United States
        • Site 18
      • Pembroke Pines, Florida, United States
        • Site 27
      • Plantation, Florida, United States
        • Site 14
      • Plantation, Florida, United States
        • Site 24
      • St. Petersburg, Florida, United States
        • Site 7
    • Georgia
      • Atlanta, Georgia, United States
        • Site 25
    • Illinois
      • Chicago, Illinois, United States
        • Site 12
      • Chicago, Illinois, United States
        • Site 1
    • Kentucky
      • Lexington, Kentucky, United States
        • Site 28
      • Madisonville, Kentucky, United States
        • Site 20
    • Massachusetts
      • Boston, Massachusetts, United States
        • Site 2
    • Nebraska
      • Omaha, Nebraska, United States
        • Site 19
    • New Jersey
      • Clementon, New Jersey, United States
        • Site 29
    • New York
      • Mt. Vernon, New York, United States
        • Site 4
    • North Carolina
      • Raleigh, North Carolina, United States
        • Site 9
    • North Dakota
      • Fargo, North Dakota, United States
        • Site 23
    • Oregon
      • Portland, Oregon, United States
        • Site 13
    • South Carolina
      • Spartanburg, South Carolina, United States
        • Site 5
    • Texas
      • Bryan, Texas, United States
        • Site 16
      • Colleyville, Texas, United States
        • Site 17
    • Virginia
      • Alexandria, Virginia, United States
        • Site 21

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Solvay Pharmaceuticals

Collaborators

Nektar Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

March 1, 2007

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

July 21, 2005

First Submitted That Met QC Criteria

July 21, 2005

First Posted (Estimate)

July 22, 2005

Study Record Updates

Last Update Posted (Estimate)

January 16, 2015

Last Update Submitted That Met QC Criteria

January 15, 2015

Last Verified

September 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S175.2.103

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Migraine Without Aura

Clinical Trials on Dronabinol MDI

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Norway

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe