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.
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
- Are there results?
- None posted in the registry
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.
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
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.
- 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)
Sponsor and investigators
- Lead sponsor
- Ambulanzpartner Soziotechnologie APST GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Charite University, Berlin, Germany
- Responsible party
- Sponsor
- Investigators
- Thomas Meyer, Prof. Dr., Study director, Ambulanzpartner Soziotechnologie APST GmbH
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
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05852418
- Acronym / sponsor ID
- EA1/219/15
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25,000 participants (estimated)
- Lead sponsor
- Ambulanzpartner Soziotechnologie APST GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Charite University, Berlin, Germany
- Study start
- 30 Oct 2015 (actual)
- Primary completion
- Dec 2024 (actual)
- Study completion
- Dec 2024 (actual)
- First posted
- 10 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Meyer, Prof. Dr. study director
Ambulanzpartner Soziotechnologie APST GmbH
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amyotrophic Lateral Sclerosis, run by Ambulanzpartner Soziotechnologie APST GmbH at 16 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The systematic recording of neurological treatment and its evaluation by patients via specific questionnaires (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.