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

Migraine Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00330850
• Other study ID #: PRO-513301
• Status: Completed
• Phase: Phase 3
• First received: May 26, 2006
• Last updated: March 30, 2007
• Start date: May 2006
• Est. completion date: December 2006

Study information

• Verified date: March 2007
• Source: ProEthic Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 650
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders
• Phonophobia
• Photophobia

Intervention

Drug:
• PRO-513

Locations

Country	Name	City	State
United States	The Innovative Clinical Research Center	Alexandria	Virginia
United States	Michigan Head-Pain and Neurologic Institute	Ann Arbor	Michigan
United States	DermResearch, Inc.	Austin	Texas
United States	J&S Studies, Inc.	Bryan	Texas
United States	Diamond Headache Clinic	Chicago	Illinois
United States	Associated Neurologists of Southern CT	Fairfield	Connecticut
United States	LCFP Inc.	Ft. Myers	Florida
United States	Headache Wellness Center	Greensboro	North Carolina
United States	Houston Headache Clinic	Houston	Texas
United States	Advanced Healthcare, S.C.	Milwaukee	Wisconsin
United States	New York Headache Center	New York	New York
United States	Palm Beach Neurological Center	Palm Beach Gardens	Florida
United States	Road Runner Research, Ltd.	San Antonio	Texas
United States	Mercy Health Research	St. Louis	Missouri
United States	New England Center for Headache	Stamford	Connecticut
United States	International Research Center	Towson	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
ProEthic Pharmaceuticals

Country where clinical trial is conducted

United States,