Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2026-01-05 @ 5:22 PM
Study NCT ID:
NCT00330850
Status:
COMPLETED
Last Update Posted:
2007-04-02
First Post:
2006-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Efficacy Study of a Single Dose Treatment of PRO-513 for Subjects Suffering a Migraine Attack
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}, {'id': 'D020795', 'term': 'Photophobia'}, {'id': 'D012001', 'term': 'Hyperacusis'}, {'id': 'D004827', 'term': 'Epilepsy'}], 'ancestors': [{'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014786', 'term': 'Vision Disorders'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006311', 'term': 'Hearing Disorders'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004008', 'term': 'Diclofenac'}], 'ancestors': [{'id': 'D010648', 'term': 'Phenylacetates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'count': 650}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'statusVerifiedDate': '2007-03', 'completionDateStruct': {'date': '2006-12'}, 'lastUpdateSubmitDate': '2007-03-30', 'studyFirstSubmitDate': '2006-05-26', 'studyFirstSubmitQcDate': '2006-05-26', 'lastUpdatePostDateStruct': {'date': '2007-04-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-05-29', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Migraine', 'Photophobia', 'Phonophobia', 'Aura'], 'conditions': ['Migraine', 'Photophobia', 'Phonophobia']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and Female subjects\n* 18-65 years of age\n* Primary diagnosis of migraine attack with aura or migraine attack without aura\n* 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\n* Female subjects must use an effective form of birth control\n* Listing of additional inclusion criteria are available through the Sponsor\n\nExclusion Criteria:\n\n* Excluding subjects with a history of other serious events causing secondary headaches\n* 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\n* 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\n* Listing of additional exclusion criteria are available through the Sponsor'}, 'identificationModule': {'nctId': 'NCT00330850', 'briefTitle': 'An Efficacy Study of a Single Dose Treatment of PRO-513 for Subjects Suffering a Migraine Attack', 'organization': {'class': 'INDUSTRY', 'fullName': 'ProEthic Pharmaceuticals'}, 'orgStudyIdInfo': {'id': 'PRO-513301'}}, 'armsInterventionsModule': {'interventions': [{'name': 'PRO-513', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06824', 'city': 'Fairfield', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Associated Neurologists of Southern CT', 'geoPoint': {'lat': 41.14121, 'lon': -73.26373}}, {'zip': '06902', 'city': 'Stamford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'New England Center for Headache', 'geoPoint': {'lat': 41.05343, 'lon': -73.53873}}, {'zip': '33907', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'LCFP Inc.', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '33410', 'city': 'Palm Beach Gardens', 'state': 'Florida', 'country': 'United States', 'facility': 'Palm Beach Neurological Center', 'geoPoint': {'lat': 26.82339, 'lon': -80.13865}}, {'zip': '60614', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Diamond Headache Clinic', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '21286', 'city': 'Towson', 'state': 'Maryland', 'country': 'United States', 'facility': 'International Research Center', 'geoPoint': {'lat': 39.4015, 'lon': -76.60191}}, {'zip': '48104', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'Michigan Head-Pain and Neurologic Institute', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Mercy Health Research', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York Headache Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27401', 'city': 'Greensboro', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Headache Wellness Center', 'geoPoint': {'lat': 36.07264, 'lon': -79.79198}}, {'zip': '78759', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'DermResearch, Inc.', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '77802', 'city': 'Bryan', 'state': 'Texas', 'country': 'United States', 'facility': 'J&S Studies, Inc.', 'geoPoint': {'lat': 30.67436, 'lon': -96.36996}}, {'zip': '77004', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston Headache Clinic', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78258', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Road Runner Research, Ltd.', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '22304', 'city': 'Alexandria', 'state': 'Virginia', 'country': 'United States', 'facility': 'The Innovative Clinical Research Center', 'geoPoint': {'lat': 38.80484, 'lon': -77.04692}}, {'zip': '53209', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Advanced Healthcare, S.C.', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'Richard Lipton, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Montefiore Headache Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ProEthic Pharmaceuticals', 'class': 'INDUSTRY'}}}}