Amyotrophic Lateral SclerosisNCT05852418

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

An observational study of Amyotrophic Lateral Sclerosis, run by Ambulanzpartner Soziotechnologie APST GmbH at 16 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Amyotrophic Lateral Sclerosis
How many people: 25,000 participants
Where: 16 sitesGermany
Study dates: 30 Oct 2015to Dec 2024
Phase: Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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.

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

Trial locations and contacts

16 sites in 1 country.

City, postcode or hospital

16 sites in 1 country

Germany16 sites

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

Other trials in Germany

About this study

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.

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.

Read the 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.

Conditions: Amyotrophic Lateral Sclerosis
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
Medical subject headings: Amyotrophic Lateral Sclerosis, Charcot-Marie-Tooth disease, Type 1F

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Oct 2015Dec 2024

First posted10 May 2023
Study start30 Oct 2015
Primary completionDec 2024
Study completionDec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Other
Enrolment: 25,000 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05852418
Sponsor's protocol ID: EA1/219/15
Status last verified: Dec 2024
First submitted: 28 Apr 2023
Last updated: 19 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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