Clinical trial NCT00330850: An Efficacy Study of a Single Dose Treatment of PRO-513 for Subjects Suffering a Migraine Attack
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine
Photophobia
Phonophobia
Keywords: Migraine
Photophobia
Phonophobia
Aura
Lead sponsor: ProEthic Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2006-05-29
Enrollment: 650
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Fairfield
country: United States
facility: Associated Neurologists of Southern CT
state: Connecticut
city: Stamford
country: United States
facility: New England Center for Headache
state: Connecticut
city: Ft. Myers
country: United States
facility: LCFP Inc.
state: Florida
city: Palm Beach Gardens
country: United States
facility: Palm Beach Neurological Center
state: Florida
city: Chicago
country: United States
facility: Diamond Headache Clinic
state: Illinois
city: Towson
country: United States
facility: International Research Center
state: Maryland
city: Ann Arbor
country: United States
facility: Michigan Head-Pain and Neurologic Institute
state: Michigan
city: St. Louis
country: United States
facility: Mercy Health Research
state: Missouri
city: New York
country: United States
facility: New York Headache Center
state: New York
city: Greensboro
country: United States
facility: Headache Wellness Center
state: North Carolina
city: Austin
country: United States
facility: DermResearch, Inc.
state: Texas
city: Bryan
country: United States
facility: J&S Studies, Inc.
state: Texas
city: Houston
country: United States
facility: Houston Headache Clinic
state: Texas
city: San Antonio
country: United States
facility: Road Runner Research, Ltd.
state: Texas
city: Alexandria
country: United States
facility: The Innovative Clinical Research Center
state: Virginia
city: Milwaukee
country: United States
facility: Advanced Healthcare, S.C.
state: Wisconsin
Study officials:
affiliation: Montefiore Headache Center
name: Richard Lipton, MD
role: PRINCIPAL_INVESTIGATOR
References: