An Efficacy Study of a Single Dose Treatment of PRO-513 for Subjects Suffering a Migraine Attack

March 30, 2007 updated by: ProEthic Pharmaceuticals
The purpose of the study is to show the efficacy of a single dose of PRO-513 for treating subjects suffering moderate pain form a migraine attack, with or without aura. The study is also intended to show the effectiveness of PRO-513 for associated symptoms of nausea, photophobia, and phonophobia due to a migraine attack.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

650

Phase

  • Phase 3

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
    • Connecticut
      • Fairfield, Connecticut, United States, 06824
        • Associated Neurologists of Southern CT
      • Stamford, Connecticut, United States, 06902
        • New England Center for Headache
    • Florida
      • Ft. Myers, Florida, United States, 33907
        • LCFP Inc.
      • Palm Beach Gardens, Florida, United States, 33410
        • Palm Beach Neurological Center
    • Illinois
      • Chicago, Illinois, United States, 60614
        • Diamond Headache Clinic
    • Maryland
      • Towson, Maryland, United States, 21286
        • International Research Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48104
        • Michigan Head-Pain and Neurologic Institute
    • Missouri
      • St. Louis, Missouri, United States, 63141
        • Mercy Health Research
    • New York
      • New York, New York, United States, 10021
        • New York Headache Center
    • North Carolina
      • Greensboro, North Carolina, United States, 27401
        • Headache Wellness Center
    • Texas
      • Austin, Texas, United States, 78759
        • Dermresearch, Inc.
      • Bryan, Texas, United States, 77802
        • J&S Studies, Inc.
      • Houston, Texas, United States, 77004
        • Houston Headache Clinic
      • San Antonio, Texas, United States, 78258
        • Road Runner Research, Ltd.
    • Virginia
      • Alexandria, Virginia, United States, 22304
        • The Innovative Clinical Research Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53209
        • Advanced Healthcare, S.C.

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 and Female subjects
  • 18-65 years of age
  • Primary diagnosis of migraine attack with aura or migraine attack without aura
  • Migraine history of averaging at least 1 migraine attack per month but averaging not more than 6 migraine attacks per month over the prior year
  • Female subjects must use an effective form of birth control
  • Listing of additional inclusion criteria are available through the Sponsor

Exclusion Criteria:

  • Excluding subjects with a history of other serious events causing secondary headaches
  • Excluding subjects with a current medical condition that could interfere with the overall study intent or affect the absorption, distribution, metabolism, or excretion of the study medication
  • Excluding subjects with a history or current medical condition that could confound the study results or use of a concomitant medication that could interfere with the study drug
  • Listing of additional exclusion criteria are available through the Sponsor

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
  • Masking: Double

Collaborators and Investigators

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

Sponsor

ProEthic Pharmaceuticals

Investigators

  • Principal Investigator: Richard Lipton, MD, Montefiore Headache Center

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

May 1, 2006

Study Completion

December 1, 2006

Study Registration Dates

First Submitted

May 26, 2006

First Submitted That Met QC Criteria

May 26, 2006

First Posted (Estimate)

May 29, 2006

Study Record Updates

Last Update Posted (Estimate)

April 2, 2007

Last Update Submitted That Met QC Criteria

March 30, 2007

Last Verified

March 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO-513301

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.

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