ClinicalTrials.gg
CompletedNCT00330850Updated Apr 2, 2007

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

A Phase 3 interventional study of PRO-513 in Migraine, Photophobia and Phonophobia, sponsored by ProEthic Pharmaceuticals. Completed at 16 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2007-04-02.

Sponsored by ProEthic Pharmaceuticals (part of Kowa Company, Ltd.) · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
650
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Migraine
  • Photophobia
  • Phonophobia

Keywords

  • Migraine
  • Photophobia
  • Phonophobia
  • Aura
03

In context

Migraine Disorders

1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.

This study's enrollment of 650 is above the median of 80 across 1,269 interventional studies indexed under Migraine Disorders.

Browse Migraine Disorders studies →

Lead sponsor

This is the only study on the registry with ProEthic Pharmaceuticals as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
  • Listing of additional inclusion criteria are available through the Sponsor

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Masking
Double
Enrollment
650 participants

Interventions

  • DrugPRO-513
06

Study locations

16 sites
  • 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
  • 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
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 2, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00330850
First posted
May 29, 2006
Start date
May 2006
Completion
Dec 2006
Last update
Apr 2, 2007

Study contacts

Richard Lipton, MD
principal investigator · Montefiore Headache Center
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2007. You cannot join it, but the record below documents what was studied.

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