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.

Study Purpose:

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.

Study Status:

Recruiting

Disease:

Amyotrophic Lateral Sclerosis

Study Type:

Observational

Type of Intervention:

N/A

Intervention Name:

N/A

Placebo:

N/A

Phase:

N/A

Study Chair(s)/Principal Investigator(s):

Thomas Meyer, Prof. Dr., Ambulanzpartner Soziotechnologie APST GmbH

Clinicaltrials.gov ID:

NCT05852418

Neals Affiliated?

No

Coordinating Center Contact Information

Thomas Meyer, Prof. Dr. / email hidden; JavaScript is required

Full Study 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 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.

Study Sponsor:

Ambulanzpartner Soziotechnologie APST GmbH

Estimated Enrollment:

25000

Estimated Study Start Date:

10 / 30 / 2015

Estimated Study Completion Date:

06 / 01 / 2025

Posting Last Modified Date:

05 / 10 / 2023

Date Study Added to neals.org:

05 / 10 / 2023

Minimum Age:

18 Years

Maximum Age:

N/A

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

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Christoph Münch | Recruiting

Christoph Münch, Prof. Dr. / +49 (0)30 450 560132 / email hidden; JavaScript is required

Berlin 13353
Germany

Neurologische Klinik und Poliklinik, Universitätsklinikum Bergmannsheil | Recruiting

Bochum
Germany

Klinik für Neurodegenrative Erkrankungen und Gerontopsychiatrie, ALS-Ambulanz und Huntington Ambulanz, Universitätsklinikum | Recruiting

Bonn
Germany

Klinik und Poliklinik für Neurologie, Medizinische Fakultät Carl Gustav Carus, Technischen Universität Dresden | Recruiting

Dresden
Germany

Neurologische Klinik, ALS-Ambulanz, Alfried Krupp Krankenhaus Rüttenscheid, Essen | Recruiting

Essen
Germany

Klinik für Neurologie, Universitätsmedizin, Georg-August-Universität Göttingen | Recruiting

Göttingen
Germany

ALS- und Muskelambulanz, Medizinische Hochschule Hannover | Recruiting

Hannover
Germany

Neurologie und Poliklinik, Universitätsklinikum | Recruiting

Heidelberg
Germany

Ambulanz für Neuromuskuläre und Motoneuron-Erkrankungen, Universitätsklinikum Jena | Recruiting

Jena
Germany

Klinik und Poliklinik für Neurologie | Recruiting

Leipzig
Germany

Klinik für Neuroogie-Präzisionsneurologie, Universitätsklinikum Schleswig-Holstein, Universität zu Lübeck | Recruiting

Lübeck
Germany

Neurologisches Klinik, Ambulanz für Motoneuronerkrankungen und ALS, Diakonissenkrankenhaus | Recruiting

Mannheim
Germany

Universitätklinikum | Recruiting

Mannheim
Germany

Klinik und Poliklinik für Neurologie, Klinikum rechts der Isar der Technischen Universität München | Recruiting

München
Germany

Klinik für Schlafmedizin und Neuromuskuläre Erkrankungen, Westfälische Willhelms-Universität Münster | Recruiting

Münster
Germany

Klinik für Innere Medizin, Neurologie, UKM Marienhospital Steinfurt | Recruiting

Steinfurt
Germany