Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2025-12-25 @ 7:04 PM
Study NCT ID:
NCT00403104
Status:
COMPLETED
Last Update Posted:
2012-06-13
First Post:
2006-11-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Placebo Controlled Study of ONO2506PO in the Presence of Riluzole in Patients With Amyotrophic Lateral Sclerosis (ALS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000690', 'term': 'Amyotrophic Lateral Sclerosis'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D016472', 'term': 'Motor Neuron Disease'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D057177', 'term': 'TDP-43 Proteinopathies'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 420}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-12', 'studyFirstSubmitDate': '2006-11-22', 'studyFirstSubmitQcDate': '2006-11-22', 'lastUpdatePostDateStruct': {'date': '2012-06-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-11-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of decline of respiratory function determined as SVC over the 12 month treatment period', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Survival', 'timeFrame': '12, 18 months'}, {'measure': 'Functional Assessment (ALSFRS-R)', 'timeFrame': '12, 18 months'}, {'measure': 'Muscle Strength (MRC muscle score)', 'timeFrame': '12, 18 months'}, {'measure': 'Quality of Life', 'timeFrame': '12, 18 months'}]}, 'conditionsModule': {'keywords': ['ONO-2506PO', 'Amyotrophic Lateral Sclerosis', 'ALS'], 'conditions': ['Amyotrophic Lateral Sclerosis (ALS)']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if oral treatment with ONO-2506PO in patients diagnosed with ALS, who have had onset of muscle weakness within 14 months of randomization, could lead to the slowing of decline in respiratory function, functional status, muscle strength, quality of life and survival compared with placebo group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosis of clinically possible, clinically probable laboratory-supported, clinically probable or clinically definite ALS (according to WNF EL Escorial diagnostic criteria, revised according to the Airlie House Conference 1998)\n2. Onset of muscle weakness within 14 months randomization\n3. Concomitant standard Riluzole therapy (50mg twice daily)\n\nExclusion Criteria:\n\n1. Presence of a tracheotomy, mechanical ventilation or non-invasive ventilation\n2. Requirement for prescription drugs used for potential neuroprotective benefit -'}, 'identificationModule': {'nctId': 'NCT00403104', 'briefTitle': 'Placebo Controlled Study of ONO2506PO in the Presence of Riluzole in Patients With Amyotrophic Lateral Sclerosis (ALS)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ono Pharmaceutical Co. Ltd'}, 'officialTitle': 'A Multi-centre, Randomized, Double Blind, Placebo-controlled, Parallel Group Study to Investigate Efficacy and Safety of ONO-2506PO Compared to Placebo, in the Presence of Riluzole, to Patients Diagnosed With Amyotrophic Lateral Sclerosis (ALS), Who Have Had Onset of Muscle Weakness Within 14 Months of Randomization', 'orgStudyIdInfo': {'id': 'ONO-2506POE014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'E', 'description': 'ONO-2506PO in the presence of Riluzole', 'interventionNames': ['Drug: ONO-2506PO']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'P', 'description': 'Placebo in the presence of Riluzole', 'interventionNames': ['Drug: ONO-2506PO']}], 'interventions': [{'name': 'ONO-2506PO', 'type': 'DRUG', 'description': '1200 mg QD / 18 months', 'armGroupLabels': ['E']}, {'name': 'ONO-2506PO', 'type': 'DRUG', 'description': '0 mg QD / 18 months', 'armGroupLabels': ['P']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1100', 'city': 'Vienna', 'country': 'Austria', 'facility': 'L. Boltzmann Forschungsinstitut, Neurologische Abteilung, Kaiser Franz Josef Hospital, Wien', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Brussels', 'country': 'Belgium', 'facility': 'UCL Saint-Luc', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'UZ Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'Hopital Roger Salengro - Clinique Neurologique, Neurologie A', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '87042', 'city': 'Limoges', 'country': 'France', 'facility': 'Hopital Duruytren', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '13005', 'city': 'Marseille', 'country': 'France', 'facility': 'Hopital de la Timone', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Hopital de Chauliac', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '06202', 'city': 'Nice', 'country': 'France', 'facility': 'Hopital l-Archet 1', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital LaPitie Salpetriere', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '13353', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charite Campus Virchow, ALS Ambulanz', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '44789', 'city': 'Bochum', 'country': 'Germany', 'facility': 'Neurologische Universitatsklinik Bergmannsheil', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'zip': '91054', 'city': 'Erlangen', 'country': 'Germany', 'facility': 'Poliklinik der Universitat Erlangen-Nurnberg, Neurologische Klinik', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}, {'zip': '06120', 'city': 'Halle', 'country': 'Germany', 'facility': 'Martin-Luther-Universitat Halle-Wittenberg, Klinikum der Medizinischen Fakultat, Universitatsklinik und Poliklinik fur Neurologie', 'geoPoint': {'lat': 51.48158, 'lon': 11.97947}}, {'zip': '30623', 'city': 'Hanover', 'country': 'Germany', 'facility': 'Medizinische Hochschule Hannover, Neurologische Klinik', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'city': 'München', 'country': 'Germany', 'facility': 'Interdisziplinares Zentrum fur Palliativmedizin', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '89081', 'city': 'Ulm', 'country': 'Germany', 'facility': 'Klinik und Poliklinik fur Neurologie der Universitat Ulm-Universitatsklinikum Ulm', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}, {'zip': '65191', 'city': 'Wiesbaden', 'country': 'Germany', 'facility': 'Deutsche Klinik fur Diagnostik, Fachbereich Neurologie', 'geoPoint': {'lat': 50.08601, 'lon': 8.24435}}, {'zip': '20149', 'city': 'Milan', 'country': 'Italy', 'facility': 'Dipartimento di Neurologia e Laboratorio di Neuroscienze - Universita di Milano - IRCCS - Istituto Auxologico Italiano', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '27100', 'city': 'Pavia', 'country': 'Italy', 'facility': 'Divisione di Neuroriabilitazione II - Fondazione Salvatore Maugeri - IRCCS', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}, {'zip': '10126', 'city': 'Torino', 'country': 'Italy', 'facility': 'Dipartimento di Neuroscienze - Divisione di Neurologia II - Azienda Ospedaliera S. Giovanni Battista - Molinette', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Academic Medical Centre (AMC) Amsterdam - Dept of Neurology', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'University Medial Center Utrecht', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'zip': '9007', 'city': 'Sankt Gallen', 'country': 'Switzerland', 'facility': 'Kantonsspital St. Gallen, Muskelzentrum/ALS Clinic', 'geoPoint': {'lat': 47.42391, 'lon': 9.37477}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Academic Neuroscience Centre', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'PR29HT', 'city': 'Preston', 'country': 'United Kingdom', 'facility': 'Royal Preston Hospital', 'geoPoint': {'lat': 53.76282, 'lon': -2.70452}}, {'city': 'Sheffield', 'country': 'United Kingdom', 'facility': 'University of Sheffield - Academic Neurology Unit', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}], 'overallOfficials': [{'name': 'Tomohiro Kuwayama', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ono Pharmaceutical Co. Ltd'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ono Pharmaceutical Co. Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}