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An Efficacy Study of a Single Dose Treatment of PRO-513 for Subjects Suffering a Migraine Attack
This study has been completed.
Sponsor:
ProEthic Pharmaceuticals
Information provided by:
ProEthic Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00330850
First received: May 26, 2006
Last updated: March 30, 2007
Last verified: March 2007
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Migraine Photophobia Phonophobia | Drug: PRO-513 | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Double-Blind Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by ProEthic Pharmaceuticals:
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00330850
Please refer to this study by its ClinicalTrials.gov identifier: NCT00330850
Locations
| United States, Connecticut | |
| Associated Neurologists of Southern CT | |
| Fairfield, Connecticut, United States, 06824 | |
| New England Center for Headache | |
| Stamford, Connecticut, United States, 06902 | |
| United States, Florida | |
| LCFP Inc. | |
| Ft. Myers, Florida, United States, 33907 | |
| Palm Beach Neurological Center | |
| Palm Beach Gardens, Florida, United States, 33410 | |
| United States, Illinois | |
| Diamond Headache Clinic | |
| Chicago, Illinois, United States, 60614 | |
| United States, Maryland | |
| International Research Center | |
| Towson, Maryland, United States, 21286 | |
| United States, Michigan | |
| Michigan Head-Pain and Neurologic Institute | |
| Ann Arbor, Michigan, United States, 48104 | |
| United States, Missouri | |
| Mercy Health Research | |
| St. Louis, Missouri, United States, 63141 | |
| United States, New York | |
| New York Headache Center | |
| New York, New York, United States, 10021 | |
| United States, North Carolina | |
| Headache Wellness Center | |
| Greensboro, North Carolina, United States, 27401 | |
| United States, Texas | |
| DermResearch, Inc. | |
| Austin, Texas, United States, 78759 | |
| J&S Studies, Inc. | |
| Bryan, Texas, United States, 77802 | |
| Houston Headache Clinic | |
| Houston, Texas, United States, 77004 | |
| Road Runner Research, Ltd. | |
| San Antonio, Texas, United States, 78258 | |
| United States, Virginia | |
| The Innovative Clinical Research Center | |
| Alexandria, Virginia, United States, 22304 | |
| United States, Wisconsin | |
| Advanced Healthcare, S.C. | |
| Milwaukee, Wisconsin, United States, 53209 | |
Sponsors and Collaborators
ProEthic Pharmaceuticals
Investigators
| Principal Investigator: | Richard Lipton, MD | Montefiore Headache Center |
More Information
| ClinicalTrials.gov Identifier: | NCT00330850 History of Changes |
| Other Study ID Numbers: |
PRO-513301 |
| Study First Received: | May 26, 2006 |
| Last Updated: | March 30, 2007 |
Keywords provided by ProEthic Pharmaceuticals:
|
Migraine Photophobia Phonophobia Aura |
Additional relevant MeSH terms:
|
Migraine Disorders Photophobia Hyperacusis Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vision Disorders Sensation Disorders Neurologic Manifestations Eye Diseases Signs and Symptoms Hearing Disorders |
Ear Diseases Otorhinolaryngologic Diseases Diclofenac Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on July 18, 2017