An Efficacy Study of a Single Dose Treatment of PRO-513 for Subjects Suffering a Migraine Attack
Information source: ProEthic Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Migraine; Photophobia; Phonophobia
Intervention: PRO-513 (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: ProEthic Pharmaceuticals Official(s) and/or principal investigator(s):
Richard Lipton, MD, Principal Investigator, Affiliation: Montefiore Headache Center
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.
Clinical Details
Study design: Treatment, Randomized, Double-Blind, Placebo Control
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Associated Neurologists of Southern CT, Fairfield, Connecticut 06824, United States
New England Center for Headache, Stamford, Connecticut 06902, United States
LCFP Inc., Ft. Myers, Florida 33907, United States
Palm Beach Neurological Center, Palm Beach Gardens, Florida 33410, United States
Diamond Headache Clinic, Chicago, Illinois 60614, United States
International Research Center, Towson, Maryland 21286, United States
Michigan Head-Pain and Neurologic Institute, Ann Arbor, Michigan 48104, United States
Mercy Health Research, St. Louis, Missouri 63141, United States
New York Headache Center, New York, New York 10021, United States
Headache Wellness Center, Greensboro, North Carolina 27401, United States
DermResearch, Inc., Austin, Texas 78759, United States
Houston Headache Clinic, Houston, Texas 77004, United States
J&S Studies, Inc., Bryan, Texas 77802, United States
Road Runner Research, Ltd., San Antonio, Texas 78258, United States
The Innovative Clinical Research Center, Alexandria, Virginia 22304, United States
Advanced Healthcare, S.C., Milwaukee, Wisconsin 53209, United States
Additional Information
Starting date: May 2006
Ending date: December 2006
Last updated: March 30, 2007
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