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:
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