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

May 2, 2023 updated by: Ambulanzpartner Soziotechnologie APST GmbH

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.

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 Overview

Status

Recruiting

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

25000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • Berlin, Germany, 13353
        • Recruiting
        • Christoph Münch
        • Contact:
      • Bochum, Germany
        • Recruiting
        • Neurologische Klinik und Poliklinik, Universitätsklinikum Bergmannsheil
      • Bonn, Germany
        • Recruiting
        • Klinik für Neurodegenrative Erkrankungen und Gerontopsychiatrie, ALS-Ambulanz und Huntington Ambulanz, Universitätsklinikum
      • Dresden, Germany
        • Recruiting
        • Klinik und Poliklinik für Neurologie, Medizinische Fakultät Carl Gustav Carus, Technischen Universität Dresden
      • Essen, Germany
        • Recruiting
        • Neurologische Klinik, ALS-Ambulanz, Alfried Krupp Krankenhaus Rüttenscheid, Essen
      • Göttingen, Germany
        • Recruiting
        • Klinik für Neurologie, Universitätsmedizin, Georg-August-Universität Göttingen
      • Hannover, Germany
        • Recruiting
        • ALS- und Muskelambulanz, Medizinische Hochschule Hannover
      • Heidelberg, Germany
        • Recruiting
        • Neurologie und Poliklinik, Universitätsklinikum
      • Jena, Germany
        • Recruiting
        • Ambulanz für Neuromuskuläre und Motoneuron-Erkrankungen, Universitätsklinikum Jena
      • Leipzig, Germany
        • Recruiting
        • Klinik und Poliklinik fur Neurologie
      • Lübeck, Germany
        • Recruiting
        • Klinik für Neuroogie-Präzisionsneurologie, Universitätsklinikum Schleswig-Holstein, Universität zu Lübeck
      • Mannheim, Germany
        • Recruiting
        • Neurologisches Klinik, Ambulanz für Motoneuronerkrankungen und ALS, Diakonissenkrankenhaus
      • Mannheim, Germany
        • Recruiting
        • Universitätklinikum
      • München, Germany
        • Recruiting
        • Klinik und Poliklinik für Neurologie, Klinikum rechts der Isar der Technischen Universität München
      • Münster, Germany
        • Recruiting
        • Klinik für Schlafmedizin und Neuromuskuläre Erkrankungen, Westfälische Willhelms-Universität Münster
      • Steinfurt, Germany
        • Recruiting
        • Klinik für Innere Medizin, Neurologie, UKM Marienhospital Steinfurt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The cohort includes patients with ALS, SMA and other chronic neurological conditions who received care with assistive devices, remedies, medications, or nursing interventions.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The systematic recording of neurological treatment and its evaluation by patients via specific questionnaires
Time Frame: 10 years
The systematic recording of neurological treatment and its evaluation by patients via specific questionnaires
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ambulanzpartner Soziotechnologie APST GmbH

Collaborators

Charite University, Berlin, Germany

Investigators

  • Study Director: Thomas Meyer, Prof. Dr., Ambulanzpartner Soziotechnologie APST GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2015

Primary Completion (Anticipated)

December 31, 2024

Study Completion (Anticipated)

June 1, 2025

Study Registration Dates

First Submitted

April 28, 2023

First Submitted That Met QC Criteria

May 2, 2023

First Posted (Actual)

May 10, 2023

Study Record Updates

Last Update Posted (Actual)

May 10, 2023

Last Update Submitted That Met QC Criteria

May 2, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EA1/219/15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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