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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00330850
Other study ID # PRO-513301
Secondary ID
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
Est. primary completion date
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


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, 

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