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NCT05852418 Clinical Trial

Registry Study of Assistive Devices, Medicines and Healthcare Measures in ALS, SMA and Other Neurological Diseases.

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:
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.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05852418
Other study ID # EA1/219/15
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 30, 2015
Est. completion date June 2025

Study information
Verified date May 2023
Source Ambulanzpartner Soziotechnologie APST GmbH
Contact Thomas Meyer, Prof. Dr.
Email t.meyer@ambulanzpartner.de
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 25000
Est. completion date June 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: Diagnosis of a chronic neurological disease - Exclusion Criteria: Lack of cooperation and unwillingness to store and share medical data collected in the registry study -

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Germany Christoph Münch Berlin
Germany Neurologische Klinik und Poliklinik, Universitätsklinikum Bergmannsheil Bochum
Germany Klinik für Neurodegenrative Erkrankungen und Gerontopsychiatrie, ALS-Ambulanz und Huntington Ambulanz, Universitätsklinikum Bonn
Germany Klinik und Poliklinik für Neurologie, Medizinische Fakultät Carl Gustav Carus, Technischen Universität Dresden Dresden
Germany Neurologische Klinik, ALS-Ambulanz, Alfried Krupp Krankenhaus Rüttenscheid, Essen Essen
Germany Klinik für Neurologie, Universitätsmedizin, Georg-August-Universität Göttingen Göttingen
Germany ALS- und Muskelambulanz, Medizinische Hochschule Hannover Hannover
Germany Neurologie und Poliklinik, Universitätsklinikum Heidelberg
Germany Ambulanz für Neuromuskuläre und Motoneuron-Erkrankungen, Universitätsklinikum Jena Jena
Germany Klinik und Poliklinik für Neurologie Leipzig
Germany Klinik für Neuroogie-Präzisionsneurologie, Universitätsklinikum Schleswig-Holstein, Universität zu Lübeck Lübeck
Germany Neurologisches Klinik, Ambulanz für Motoneuronerkrankungen und ALS, Diakonissenkrankenhaus Mannheim
Germany Universitätklinikum Mannheim
Germany Klinik und Poliklinik für Neurologie, Klinikum rechts der Isar der Technischen Universität München München
Germany Klinik für Schlafmedizin und Neuromuskuläre Erkrankungen, Westfälische Willhelms-Universität Münster Münster
Germany Klinik für Innere Medizin, Neurologie, UKM Marienhospital Steinfurt Steinfurt

Sponsors (2)
Lead Sponsor Collaborator
Ambulanzpartner Soziotechnologie APST GmbH Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary The systematic recording of neurological treatment and its evaluation by patients via specific questionnaires The systematic recording of neurological treatment and its evaluation by patients via specific questionnaires 10 years
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