Migraine Clinical Trial
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 |
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.
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 |
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
ProEthic Pharmaceuticals |
United States,
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