Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2026-02-20 @ 1:46 PM
Study NCT ID:
NCT01955369
Status:
COMPLETED
Last Update Posted:
2016-05-19
First Post:
2013-09-28
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Amyotrophic Lateral Sclerosis Registry Rhineland-Palatinate
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'joachim.wolf@diakonissen.de', 'phone': '0049-621', 'title': 'Dr. Joachim Wolf', 'phoneExt': '4200', 'organization': 'Klinikum der Stadt Ludwigshafen'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Amyotrophic Lateral Sclerosis Patients', 'description': 'Patients were included into the registry if they had a new diagnosis of ALS, a minimum age of 18 years and lived in Rhineland-Palatinate for at least 6 months before date of diagnosis. Diagnosis was based upon the revised El Escorial criteria.', 'otherNumAtRisk': 200, 'otherNumAffected': 0, 'seriousNumAtRisk': 200, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Amyotrophic Lateral Sclerosis Patients', 'description': 'Patients were included into the registry if they had a new diagnosis of ALS, a minimum age of 18 years and lived in Rhineland-Palatinate for at least 6 months before date of diagnosis. Diagnosis was based upon the revised El Escorial criteria.'}], 'classes': [{'categories': [{'measurements': [{'value': '134', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'an average of 3 years', 'description': 'death of participating ALS patients independent of the cause of death', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Tracheostomy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Amyotrophic Lateral Sclerosis Patients', 'description': 'Patients were included into the registry if they had a new diagnosis of ALS, a minimum age of 18 years and lived in Rhineland-Palatinate for at least 6 months before date of diagnosis. Diagnosis was based upon the revised El Escorial criteria.'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'an average of 3 years', 'description': 'tracheostomy in ALS patients following respiratory failure', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Gastrostomy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Amyotrophic Lateral Sclerosis Patients', 'description': 'Patients were included into the registry if they had a new diagnosis of ALS, a minimum age of 18 years and lived in Rhineland-Palatinate for at least 6 months before date of diagnosis. Diagnosis was based upon the revised El Escorial criteria.'}], 'classes': [{'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'an average of 3 years', 'description': 'gastrostomy of ALS patients following weight loss and/or swallowing problems with aspiration', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Amyotrophic Lateral Sclerosis Patients', 'description': 'Patients were included into the registry if they had a new diagnosis of ALS, a minimum age of 18 years and lived in Rhineland-Palatinate for at least 6 months before date of diagnosis. Diagnosis was based upon the revised El Escorial criteria.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '200'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '200'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Amyotrophic Lateral Sclerosis Patients', 'description': 'Patients were included into the registry if they had a new diagnosis of ALS, a minimum age of 18 years and lived in Rhineland-Palatinate for at least 6 months before date of diagnosis. Diagnosis was based upon the revised El Escorial criteria.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.8', 'groupId': 'BG000', 'lowerLimit': '23', 'upperLimit': '85'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '94', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '106', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-13', 'studyFirstSubmitDate': '2013-09-28', 'resultsFirstSubmitDate': '2015-04-06', 'studyFirstSubmitQcDate': '2013-09-28', 'lastUpdatePostDateStruct': {'date': '2016-05-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-04-06', 'studyFirstPostDateStruct': {'date': '2013-10-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-04-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Gastrostomy', 'timeFrame': 'an average of 3 years', 'description': 'gastrostomy of ALS patients following weight loss and/or swallowing problems with aspiration'}], 'primaryOutcomes': [{'measure': 'Death', 'timeFrame': 'an average of 3 years', 'description': 'death of participating ALS patients independent of the cause of death'}], 'secondaryOutcomes': [{'measure': 'Tracheostomy', 'timeFrame': 'an average of 3 years', 'description': 'tracheostomy in ALS patients following respiratory failure'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['incidence', 'phenotype', 'mortality'], 'conditions': ['Amyotrophic Lateral Sclerosis']}, 'referencesModule': {'references': [{'pmid': '25895515', 'type': 'BACKGROUND', 'citation': 'Wolf J, Safer A, Wohrle JC, Palm F, Nix WA, Maschke M, Grau AJ. Factors Predicting Survival in ALS Patients--Data from a Population-Based Registry in Rhineland-Palatinate, Germany. Neuroepidemiology. 2015;44(3):149-55. doi: 10.1159/000381625. Epub 2015 Apr 21.'}, {'pmid': '24571628', 'type': 'RESULT', 'citation': 'Wolf J, Wohrle JC, Palm F, Nix WA, Maschke M, Safer A, Becher H, Grau AJ. Incidence of amyotrophic lateral sclerosis in Rhineland-Palatinate, Germany. Amyotroph Lateral Scler Frontotemporal Degener. 2014 Jun;15(3-4):269-74. doi: 10.3109/21678421.2014.887733. Epub 2014 Feb 26.'}, {'pmid': '25086855', 'type': 'RESULT', 'citation': 'Wolf J, Safer A, Wohrle JC, Palm F, Nix WA, Maschke M, Grau AJ. Variability and prognostic relevance of different phenotypes in amyotrophic lateral sclerosis - data from a population-based registry. J Neurol Sci. 2014 Oct 15;345(1-2):164-7. doi: 10.1016/j.jns.2014.07.033. Epub 2014 Jul 19.'}, {'pmid': '25280575', 'type': 'RESULT', 'citation': 'Wolf J, Safer A, Wohrle JC, Palm F, Nix WA, Maschke M, Grau AJ. Factors predicting one-year mortality in amyotrophic lateral sclerosis patients--data from a population-based registry. BMC Neurol. 2014 Oct 4;14:197. doi: 10.1186/s12883-014-0197-9.'}], 'seeAlsoLinks': [{'url': 'http://www.als-register.org', 'label': 'Amyotrophic lateral sclerosis registry Rhineland-Palatinate'}]}, 'descriptionModule': {'briefSummary': 'There is a lack of prospective and population-based epidemiological data on amyotrophic lateral sclerosis in Germany so far. The purpose of this registry is to investigate the incidence, course and phenotypic variety of ALS in Rhineland-Palatinate, a South-West German state of about 4 million inhabitants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'residents of the state of Rhineland-Palatinate, Germany (4 million inhabitants)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of amyotrophic lateral sclerosis according to revised El Escorial criteria\n* minimum of 18 years\n* minimum of 6 months of residency in Rhinelnad-Palatinate\n\nExclusion Criteria:\n\n* patients below 18 years\n* ALS patients outside Rhineland-Palatinate'}, 'identificationModule': {'nctId': 'NCT01955369', 'briefTitle': 'Amyotrophic Lateral Sclerosis Registry Rhineland-Palatinate', 'organization': {'class': 'OTHER', 'fullName': 'Klinikum Ludwigshafen'}, 'officialTitle': 'Amyotrophic Lateral Sclerosis Registry Rhineland-Palatinate', 'orgStudyIdInfo': {'id': '837.253.09'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Amyotrophic lateral sclerosis patients', 'description': 'Patients were included into the registry if they had a new diagnosis of ALS, a minimum age of 18 years and lived in Rhineland-Palatinate for at least 6 months before date of diagnosis. Diagnosis was based upon the revised El Escorial criteria.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '67063', 'city': 'Ludwigshafen', 'country': 'Germany', 'facility': 'Dept. of Neurology, Klinikum Ludwigshafen', 'geoPoint': {'lat': 47.81663, 'lon': 9.06138}}], 'overallOfficials': [{'name': 'Joachim Wolf, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dept. Neurology, Klinikum Ludwigshafen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Klinikum Ludwigshafen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior neurologist of the Dept. of Neurology', 'investigatorFullName': 'Joachim Wolf', 'investigatorAffiliation': 'Klinikum Ludwigshafen'}}}}