Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-26 @ 4:08 AM
Study NCT ID:
NCT05852418
Status:
RECRUITING
Last Update Posted:
2025-01-29
First Post:
2023-04-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Registry Study of Assistive Devices, Medicines and Healthcare Measures in ALS, SMA and Other Neurological Diseases.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000690', 'term': 'Amyotrophic Lateral Sclerosis'}, {'id': 'C537987', 'term': 'Charcot-Marie-Tooth disease, Type 1F'}], '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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-12-22', 'size': 441505, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-04-24T09:29', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-10-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2029-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-28', 'studyFirstSubmitDate': '2023-04-28', 'studyFirstSubmitQcDate': '2023-05-02', 'lastUpdatePostDateStruct': {'date': '2025-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The systematic recording of neurological treatment and its evaluation by patients via specific questionnaires', 'timeFrame': '10 years', 'description': 'The systematic recording of neurological treatment and its evaluation by patients via specific questionnaires'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ALS Registry study', 'SMA Registry study', 'ALS medication and care registry study', 'SMA medication and care registry study', 'NfL', 'Neurofilament light chain', 'ALSFRS-R', 'ALS-App', 'ALS', 'APST Research', 'Biomarker', 'Tofersen', 'Nusinersen', 'Risdiplam'], 'conditions': ['Amyotrophic Lateral Sclerosis']}, 'descriptionModule': {'briefSummary': 'This registry study aims to collect data on the provision of assistive devices, medicines, and other healthcare measures, such as ventilation therapy and nutrition support, in patients with Amyotrophic lateral sclerosis (ALS), Spinal muscular atrophy (SMA) and other neurological disorders. The data collected should describe the clinical practice, meaning real-world evidence and patient-reported outcomes.', 'detailedDescription': 'This registry study aims to collect data on the provision of assistive devices, medicines, and other healthcare measures, such as ventilation therapy and nutrition support, in patients with ALS, SMA and other neurological disorders. The data collected should describe the clinical practice, meaning real-world evidence and patient-reported outcomes. The collected data include clinical characteristics, medical history, assessment scales, such as ALS functional rating scale-revised (ALSFRS-R), prognosis indicators, such as ALS progression rate, biomarker data, such as serum Neurofilament light chain (sNfL), genetic data, such as the mutation status of SOD1, FUS, c9orf72, TARDBP in ALS, SMN1 in SMA patients, innovative drugs such as Tofersen, Nusinersen, Risdiplam, as well as symptomatic drugs, patient-reported outcome data being captured using questionnaires and established clinical scales on medication expectation and treatment satisfaction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The cohort includes patients with ALS, SMA and other chronic neurological conditions who received care with assistive devices, remedies, medications, or nursing interventions.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: Diagnosis of a chronic neurological disease -\n\nExclusion Criteria: Lack of cooperation and unwillingness to store and share medical data collected in the registry study\n\n\\-'}, 'identificationModule': {'nctId': 'NCT05852418', 'briefTitle': 'Registry Study of Assistive Devices, Medicines and Healthcare Measures in ALS, SMA and Other Neurological Diseases.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ambulanzpartner Soziotechnologie APST GmbH'}, 'officialTitle': 'Registry Study of the Provision of Assistive Devices, Medicines, and Other Healthcare Measures in an Inter-cohort Observation of Patients With ALS , SMA and Other Neurological Diseases.', 'orgStudyIdInfo': {'id': 'EA1/219/15'}}, 'contactsLocationsModule': {'locations': [{'zip': '13353', 'city': 'Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Christoph Münch, Prof. Dr.', 'role': 'CONTACT', 'email': 'christoph.muench@charite.de', 'phone': '+49 (0)30 450 560132'}], 'facility': 'Christoph Münch', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Bochum', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Neurologische Klinik und Poliklinik, Universitätsklinikum Bergmannsheil', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'city': 'Bonn', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Klinik für Neurodegenrative Erkrankungen und Gerontopsychiatrie, ALS-Ambulanz und Huntington Ambulanz, Universitätsklinikum', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'city': 'Dresden', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Klinik und Poliklinik für Neurologie, Medizinische Fakultät Carl Gustav Carus, Technischen Universität Dresden', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'city': 'Essen', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Neurologische Klinik, ALS-Ambulanz, Alfried Krupp Krankenhaus Rüttenscheid, Essen', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'city': 'Göttingen', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Klinik für Neurologie, Universitätsmedizin, Georg-August-Universität Göttingen', 'geoPoint': {'lat': 51.53443, 'lon': 9.93228}}, {'city': 'Hanover', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'ALS- und Muskelambulanz, Medizinische Hochschule Hannover', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'city': 'Heidelberg', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Neurologie und Poliklinik, Universitätsklinikum', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'city': 'Jena', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Ambulanz für Neuromuskuläre und Motoneuron-Erkrankungen, Universitätsklinikum Jena', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}, {'city': 'Leipzig', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Klinik und Poliklinik für Neurologie', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'city': 'Lübeck', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Klinik für Neuroogie-Präzisionsneurologie, Universitätsklinikum Schleswig-Holstein, Universität zu Lübeck', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}, {'city': 'Mannheim', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Neurologisches Klinik, Ambulanz für Motoneuronerkrankungen und ALS, Diakonissenkrankenhaus', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}, {'city': 'Mannheim', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Universitätklinikum', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}, {'city': 'München', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Klinik und Poliklinik für Neurologie, Klinikum rechts der Isar der Technischen Universität München', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'city': 'Münster', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Klinik für Schlafmedizin und Neuromuskuläre Erkrankungen, Westfälische Willhelms-Universität Münster', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'city': 'Steinfurt', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Klinik für Innere Medizin, Neurologie, UKM Marienhospital Steinfurt', 'geoPoint': {'lat': 52.15045, 'lon': 7.33664}}], 'centralContacts': [{'name': 'Thomas Meyer, Prof. Dr.', 'role': 'CONTACT', 'email': 't.meyer@ambulanzpartner.de'}, {'name': 'Senthil Kumar Subramanian, Dr.', 'role': 'CONTACT', 'email': 'sk.subramanian@ambulanzpartner.de', 'phone': '+4930810314118'}], 'overallOfficials': [{'name': 'Thomas Meyer, Prof. Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ambulanzpartner Soziotechnologie APST GmbH'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ambulanzpartner Soziotechnologie APST GmbH', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}