An Efficacy Study of a Single Dose Treatment of PRO-513 for Subjects Suffering a Migraine Attack
1 other identifier
interventional
650
1 country
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2006
Shorter than P25 for phase_3
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 26, 2006
CompletedFirst Posted
Study publicly available on registry
May 29, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedApril 2, 2007
March 1, 2007
May 26, 2006
March 30, 2007
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Male and Female subjects
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Associated Neurologists of Southern CT
Fairfield, Connecticut, 06824, United States
New England Center for Headache
Stamford, Connecticut, 06902, United States
LCFP Inc.
Fort 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
J&S Studies, Inc.
Bryan, Texas, 77802, United States
Houston Headache Clinic
Houston, Texas, 77004, 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard Lipton, MD
Montefiore Headache Center
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 26, 2006
First Posted
May 29, 2006
Study Start
May 1, 2006
Study Completion
December 1, 2006
Last Updated
April 2, 2007
Record last verified: 2007-03