Ignite Creation Date:
2025-12-24 @ 9:37 PM
Ignite Modification Date:
2025-12-30 @ 5:49 AM
Study NCT ID:
NCT00050232
Status:
COMPLETED
Last Update Posted:
2016-07-14
First Post:
2002-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of AVP-923 for Pseudobulbar Affect in Multiple Sclerosis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D007845', 'term': 'Laughter'}, {'id': 'D003448', 'term': 'Crying'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D009633', 'term': 'Nonverbal Communication'}, {'id': 'D003142', 'term': 'Communication'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C507057', 'term': 'dextromethorphan - quinidine combination'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2004-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-13', 'studyFirstSubmitDate': '2002-12-02', 'studyFirstSubmitQcDate': '2002-12-02', 'lastUpdatePostDateStruct': {'date': '2016-07-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'emotional control'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pseudobulbar Affect', 'Uncontrolled', 'Laughing', 'Crying'], 'conditions': ['Multiple Sclerosis']}, 'referencesModule': {'references': [{'pmid': '16634036', 'type': 'RESULT', 'citation': 'Panitch HS, Thisted RA, Smith RA, Wynn DR, Wymer JP, Achiron A, Vollmer TL, Mandler RN, Dietrich DW, Fletcher M, Pope LE, Berg JE, Miller A; Psuedobulbar Affect in Multiple Sclerosis Study Group. Randomized, controlled trial of dextromethorphan/quinidine for pseudobulbar affect in multiple sclerosis. Ann Neurol. 2006 May;59(5):780-7. doi: 10.1002/ana.20828.'}], 'seeAlsoLinks': [{'url': 'http://www.nmss.org', 'label': 'National Multiple Sclerosis Society'}]}, 'descriptionModule': {'briefSummary': 'Pseudobulbar Affect is a condition characterized by frequent episodes of laughing and crying out of proportion. Other terms used to describe this condition include emotional lability, emotionalism, emotion incontinence, emotional discontrol, excessive emotionalism and pathological laughing and crying. AVP-923 is a new experimental drug that may assist in the reduction of uncontrolled episodes. This study will test the safety and efficacy of AVP-923 in the treatment of MS patients suffering from pseudobulbar affect.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '68 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 to 68 years of age\n* Confirmed diagnosis of Multiple Sclerosis\n* Clinical history of pseudobulbar affect\n\nExclusion Criteria:\n\n* Sensitivity to quinidine or opiate drugs\n* Recent diagnosed within 2 months with Multiple Sclerosis\n* Patient on anti-depressants\n* Patient with liver or kidney disease\n* Patient with hypotension'}, 'identificationModule': {'nctId': 'NCT00050232', 'briefTitle': 'Safety and Efficacy of AVP-923 for Pseudobulbar Affect in Multiple Sclerosis Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Avanir Pharmaceuticals'}, 'orgStudyIdInfo': {'id': '02-AVR-106'}}, 'armsInterventionsModule': {'interventions': [{'name': 'AVP-923', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Barrow Neurological Institute', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '20037', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'George Washington University Medical Faculty Associates', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33334', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Neurological Associates', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '30033', 'city': 'Decatur', 'state': 'Georgia', 'country': 'United States', 'facility': 'Neurology & Headache Specialist of Atlanta, L.L.C.', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}, {'zip': '60007', 'city': 'Elk Grove Village', 'state': 'Illinois', 'country': 'United States', 'facility': 'Radiant Research Alexian Brothers', 'geoPoint': {'lat': 42.00392, 'lon': -87.97035}}, {'zip': '60062', 'city': 'Northbrook', 'state': 'Illinois', 'country': 'United States', 'facility': 'Consultants in Neurology LTD', 'geoPoint': {'lat': 42.12753, 'lon': -87.82895}}, {'zip': '59405', 'city': 'Great Falls', 'state': 'Montana', 'country': 'United States', 'facility': 'Advanced Neurology Specialists', 'geoPoint': {'lat': 47.50024, 'lon': -111.30081}}, {'zip': '68506', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Neurological Associates, P.C.', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '12205', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'Upstate Clinical Research', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '14266', 'city': 'Amherst', 'state': 'New York', 'country': 'United States', 'facility': 'DENT Neurologic Group L.L.P.', 'geoPoint': {'lat': 42.97839, 'lon': -78.79976}}, {'zip': '10003', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Hospital for Joint Diseases - MS Care Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '13210', 'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'Institute for Human Performance', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'zip': '27607', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Raleigh Neurology Associates, P.A.', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '44718', 'city': 'Canton', 'state': 'Ohio', 'country': 'United States', 'facility': 'NeuroCare Center, Inc.', 'geoPoint': {'lat': 40.79895, 'lon': -81.37845}}, {'zip': '18103', 'city': 'Allentown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Leheigh Valley Neurosciences and Pain Research Center', 'geoPoint': {'lat': 40.60843, 'lon': -75.49018}}, {'zip': '15601', 'city': 'Greensburg', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Westmorland Neurology', 'geoPoint': {'lat': 40.30146, 'lon': -79.53893}}, {'zip': '19013', 'city': 'Upland', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Neurological Associates of Delaware Valley', 'geoPoint': {'lat': 39.85261, 'lon': -75.38269}}, {'zip': '05401', 'city': 'Burlington', 'state': 'Vermont', 'country': 'United States', 'facility': 'FACH-UHC Department of Neurological Services', 'geoPoint': {'lat': 44.47588, 'lon': -73.21207}}, {'zip': '98122', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Swedish Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98405', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'Neurology and Neurosurgery Associates of Tacoma', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Avanir Pharmaceuticals', 'class': 'INDUSTRY'}}}}