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

Primary Purpose

Migraine, Photophobia, Phonophobia

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
PRO-513
Sponsored by
ProEthic Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine focused on measuring Migraine, Photophobia, Phonophobia, Aura

Eligibility Criteria

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

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

Sites / Locations

  • Associated Neurologists of Southern CT
  • New England Center for Headache
  • LCFP Inc.
  • Palm Beach Neurological Center
  • Diamond Headache Clinic
  • International Research Center
  • Michigan Head-Pain and Neurologic Institute
  • Mercy Health Research
  • New York Headache Center
  • Headache Wellness Center
  • DermResearch, Inc.
  • J&S Studies, Inc.
  • Houston Headache Clinic
  • Road Runner Research, Ltd.
  • The Innovative Clinical Research Center
  • Advanced Healthcare, S.C.

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 26, 2006
Last Updated
March 30, 2007
Sponsor
ProEthic Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00330850
Brief Title
An Efficacy Study of a Single Dose Treatment of PRO-513 for Subjects Suffering a Migraine Attack
Study Type
Interventional

2. Study Status

Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
ProEthic Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine, Photophobia, Phonophobia
Keywords
Migraine, Photophobia, Phonophobia, Aura

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Masking
Double
Allocation
Randomized
Enrollment
650 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
PRO-513

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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Lipton, MD
Organizational Affiliation
Montefiore Headache Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Associated Neurologists of Southern CT
City
Fairfield
State/Province
Connecticut
ZIP/Postal Code
06824
Country
United States
Facility Name
New England Center for Headache
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06902
Country
United States
Facility Name
LCFP Inc.
City
Ft. Myers
State/Province
Florida
ZIP/Postal Code
33907
Country
United States
Facility Name
Palm Beach Neurological Center
City
Palm Beach Gardens
State/Province
Florida
ZIP/Postal Code
33410
Country
United States
Facility Name
Diamond Headache Clinic
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614
Country
United States
Facility Name
International Research Center
City
Towson
State/Province
Maryland
ZIP/Postal Code
21286
Country
United States
Facility Name
Michigan Head-Pain and Neurologic Institute
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48104
Country
United States
Facility Name
Mercy Health Research
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
New York Headache Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Headache Wellness Center
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
Facility Name
DermResearch, Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
J&S Studies, Inc.
City
Bryan
State/Province
Texas
ZIP/Postal Code
77802
Country
United States
Facility Name
Houston Headache Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Road Runner Research, Ltd.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Facility Name
The Innovative Clinical Research Center
City
Alexandria
State/Province
Virginia
ZIP/Postal Code
22304
Country
United States
Facility Name
Advanced Healthcare, S.C.
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53209
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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