ALS (Amyotrophic Lateral Sclerosis)NCT07900672
Register for Medical Data, Functional Scales, and Care Outcomes in ALS, SMA, and Other Motor System Disorders
An observational study of ALS (Amyotrophic Lateral Sclerosis) and SMA - Spinal Muscular Atrophy, run by Ambulanzpartner Soziotechnologie APST GmbH at 1 site in Germany.
Trial summary
This observational registry collects existing medical and routine care data from people with amyotrophic lateral sclerosis (ALS), spinal muscular atrophy (SMA), and other motor system disorders. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- ALS (Amyotrophic Lateral Sclerosis), SMA - Spinal Muscular Atrophy, Spinal Cord Diseases
- How many people
- 2,000 participants
- Where
- 1 siteGermany
- Study dates
- 1 Oct 2026to 31 Dec 2035
- How long will I take part?
- 50 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Adults aged 18 years or older with amyotrophic lateral sclerosis (ALS), spinal muscular atrophy (SMA), or another motor system disorder are eligible for this registry. Participants receive or have previously received routine care involving assistive devices, therapeutic services, medications, nutritional support, or respiratory support. They are recruited through specialized outpatient clinics, neurological clinics, university outpatient departments, authorized outpatient centers, and specialist practices participating in the registry in Germany.
Who may be able to join
- Patients aged 18 and over
- Diagnosis of amyotrophic lateral sclerosis (ALS), spinal muscular atrophy (SMA), or another motor system disorders
Who cannot join
- Inability or unwillingness to provide informed consent
- Withdrawal of informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Marie-Therese Henke contact
Germany1 site, 1 recruiting
- Recruiting
Charité - Universitätsmedizin Berlin; Charité Centrum für Neurologie, Neurochirurgie und Psychiatrie; Ambulanz für ALS, SMA und andere Motoneuronerkrankungen
Berlin, State of Berlin, 13353
Thomas Meyer, Prof. Dr., +49 30 450 560032, thomas.meyer@charite.de
About this study
Official title: Register Zur Erfassung Medizinischer Daten, Funktioneller Skalen Und Von Verlaufsparametern in Der Hilfsmittel-, Heilmittel-, Beatmungs-, Ernährungs-, Medikamenten- Und Pflegeversorgung Von Patienten Mit Amyotropher Lateralsklerose (ALS), Spinaler Muskelatrophie (SMA) Und Anderen Motorischen Systemerkrankungen
This observational registry collects existing medical and routine care data from people with amyotrophic lateral sclerosis (ALS), spinal muscular atrophy (SMA), and other motor system disorders. The registry includes information about disease course, functional abilities, medications, medical devices, therapeutic services, nutrition, breathing support, and nursing care. It may also include patients' assessments of their treatment and care.
The main goal is to describe how people with these conditions are treated and supported in routine clinical practice. The collected data will be used to study care delivery, patient outcomes, and changes in care over time. The findings may help answer research questions and support the future development of treatment standards and clinical care guidelines.
This registry does not require any additional medical, nursing, or therapeutic intervention. It uses data generated during routine care and may include information reported by patients or a person authorized by them. The registry is operated by Ambulanzpartner Soziotechnologie APST GmbH in cooperation with Charité - Universitätsmedizin Berlin.
Read the detailed description
This is an ongoing, non-interventional patient registry that systematically and longitudinally collects routine-care data from people with amyotrophic lateral sclerosis, spinal muscular atrophy, and other motor system disorders. Historical, current, and prospective information is obtained from medical records, data collection forms completed by patients or health care professionals, and data exports from software applications used in routine care. Data voluntarily entered into mobile applications may be transferred only at the participant's request and with explicit consent. The applications themselves are not evaluated as part of the registry.
The registry includes a predefined core dataset that is collected routinely and additional optional variables. The data dictionary describes the variables, their measurement instruments, and whether they belong to the core or optional dataset. Data categories include demographic characteristics, diagnoses, disease onset and clinical features, functional measures, and information on assistive devices, therapeutic services, medication, respiratory and nutritional support, nursing care, patient experience, and satisfaction.
The registry operator is responsible for technical operation, data infrastructure, and compliance with data protection requirements. Data are stored and processed on a protected, encrypted server at Charité - Universitätsmedizin Berlin. Charité provides scientific oversight and is responsible for the study design, scientific quality assurance, and evaluation of registry data. Data used for statistical analyses are pseudonymized.
Quality assurance is performed by the registry operator. Registry data are regularly reviewed for completeness and plausibility, and identified inconsistencies are assessed and corrected or supplemented where appropriate. Data may be checked against source documents generated during routine care, including medical reports, physician letters, questionnaires, and electronic data exports. The available documents do not specify routine on-site monitoring, independent audits, third-party certification, or a formal source-data-verification rate.
Internal exploratory and descriptive analyses are performed at regular intervals and documented in status reports. These may include participant counts and summaries of the collected variables. Analyses addressing a specific scientific hypothesis require a formal registry-study application and are governed by the registry's data-use rules. No formal effect-based sample size calculation is specified because the registry is intended for ongoing data collection and does not have a predefined end date.
The available documents do not describe a separate statistical method for imputing missing data. The core and optional dataset structure permits variables that are not routinely available to remain unreported, while completeness and plausibility checks are used to identify missing, inconsistent, or out-of-range entries. The handling of missing data for a specific research question should be defined in the corresponding analysis plan.
Scientific publications based on registry data must follow good scientific practice and applicable reporting standards for observational research. The registry must be identified as the data source, and the registry operator must be informed about planned publications. Study-specific publications undergo peer review to support the quality, plausibility, and reproducibility of the findings.
- Conditions
- ALS (Amyotrophic Lateral Sclerosis), SMA - Spinal Muscular Atrophy, Spinal Cord Diseases, Central Nervous System Diseases, Nervous System Diseases, Motor Neuron Disease
- Being tested
- Standard of Care (Investigator Choice)
- Keywords
- Registry, Motoneuron diseases, ALS Registry, SMA Registry, ALS medication and care registry, SMA medication and care registry, NfL, Neurofilament light chain, ALSFRS-R, ALS-App, ALS, APST
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Muscular Atrophy, Spinal, Spinal Cord Diseases, Central Nervous System Diseases, Nervous System Diseases, Motor Neuron Disease, Neurodegenerative Diseases, TDP-43 Proteinopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of Care (Investigator Choice)Other
This is a non-interventional patient registry. No investigational treatment, procedure, or care strategy is assigned. Participants continue to receive routine care determined by their treating health care professionals. The registry collects historical, current, and future routine-care data from medical records, questionnaires, and, with explicit consent, data exported from software or mobile applications such as the ALS App or SMA App. These applications are not tested or evaluated as interventions in this study. Data may cover medical history, disease course, functional status, medications, assistive devices, therapeutic services, respiratory and nutritional support, and nursing care.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and Percentage of Participants Receiving Each Type of Routine Care Intervention at Enrollment
The number and percentage of participants receiving assistive devices, therapeutic services, respiratory support, nutritional support, medication, and nursing care at the time of enrollment will be reported.
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Dec 2035 (estimated)
- Study completion31 Dec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ALS (Amyotrophic Lateral Sclerosis)Studies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 50 Years
Sponsor and investigators
- Lead sponsor
- Ambulanzpartner Soziotechnologie APST GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Charite University, Berlin, Germany
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07900672
- Sponsor's protocol ID
- APST Register
- Other IDs
- 2026-101-CCM
- Status last verified
- Sep 2026
- First submitted
- 6 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Register Zur Erfassung Medizinischer Daten, Funktioneller Skalen Und Von Verlaufsparametern in Der Hilfsmittel-, Heilmittel-, Beatmungs-, Ernährungs-, Medikamenten- Und Pflegeversorgung Von Patienten Mit Amyotropher Lateralsklerose (ALS), Spinaler Muskelatrophie (SMA) Und Anderen Motorischen Systemerkrankungen
- ClinicalTrials.gov ID
- NCT07900672
- Acronym / sponsor ID
- APST Register
- Conditions
- ALS (Amyotrophic Lateral Sclerosis), SMA - Spinal Muscular Atrophy, Spinal Cord Diseases, Central Nervous System Diseases, Nervous System Diseases, Motor Neuron Disease
- Keywords
- Registry, Motoneuron diseases, ALS Registry, SMA Registry, ALS medication and care registry, SMA medication and care registry, NfL, Neurofilament light chain
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Ambulanzpartner Soziotechnologie APST GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Charite University, Berlin, Germany
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2035 (estimated)
- Study completion
- 31 Dec 2035 (estimated)
- First posted
- 28 Oct 2026 (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 observational registry collects existing medical and routine care data from people with amyotrophic lateral sclerosis (ALS), spinal muscular atrophy (SMA), and other motor system disorders. The registry includes information about disease course, functional abilities, medications, medical devices, therapeutic services, nutrition, breathing support, and nursing care. It may also include patients' assessments of their treatment and care.
The main goal is to describe how people with these conditions are treated and supported in routine clinical practice. The collected data will be used to study care delivery, patient outcomes, and changes in care over time. The findings may help answer research questions and support the future development of treatment standards and clinical care guidelines.
This registry does not require any additional medical, nursing, or therapeutic intervention. It uses data generated during routine care and may include information reported by patients or a person authorized by them. The registry is operated by Ambulanzpartner Soziotechnologie APST GmbH in cooperation with Charité - Universitätsmedizin Berlin.
Detailed description
This is an ongoing, non-interventional patient registry that systematically and longitudinally collects routine-care data from people with amyotrophic lateral sclerosis, spinal muscular atrophy, and other motor system disorders. Historical, current, and prospective information is obtained from medical records, data collection forms completed by patients or health care professionals, and data exports from software applications used in routine care. Data voluntarily entered into mobile applications may be transferred only at the participant's request and with explicit consent. The applications themselves are not evaluated as part of the registry.
The registry includes a predefined core dataset that is collected routinely and additional optional variables. The data dictionary describes the variables, their measurement instruments, and whether they belong to the core or optional dataset. Data categories include demographic characteristics, diagnoses, disease onset and clinical features, functional measures, and information on assistive devices, therapeutic services, medication, respiratory and nutritional support, nursing care, patient experience, and satisfaction.
The registry operator is responsible for technical operation, data infrastructure, and compliance with data protection requirements. Data are stored and processed on a protected, encrypted server at Charité - Universitätsmedizin Berlin. Charité provides scientific oversight and is responsible for the study design, scientific quality assurance, and evaluation of registry data. Data used for statistical analyses are pseudonymized.
Quality assurance is performed by the registry operator. Registry data are regularly reviewed for completeness and plausibility, and identified inconsistencies are assessed and corrected or supplemented where appropriate. Data may be checked against source documents generated during routine care, including medical reports, physician letters, questionnaires, and electronic data exports. The available documents do not specify routine on-site monitoring, independent audits, third-party certification, or a formal source-data-verification rate.
Internal exploratory and descriptive analyses are performed at regular intervals and documented in status reports. These may include participant counts and summaries of the collected variables. Analyses addressing a specific scientific hypothesis require a formal registry-study application and are governed by the registry's data-use rules. No formal effect-based sample size calculation is specified because the registry is intended for ongoing data collection and does not have a predefined end date.
The available documents do not describe a separate statistical method for imputing missing data. The core and optional dataset structure permits variables that are not routinely available to remain unreported, while completeness and plausibility checks are used to identify missing, inconsistent, or out-of-range entries. The handling of missing data for a specific research question should be defined in the corresponding analysis plan.
Scientific publications based on registry data must follow good scientific practice and applicable reporting standards for observational research. The registry must be identified as the data source, and the registry operator must be informed about planned publications. Study-specific publications undergo peer review to support the quality, plausibility, and reproducibility of the findings.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 50 Years
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Adults aged 18 years or older with amyotrophic lateral sclerosis (ALS), spinal muscular atrophy (SMA), or another motor system disorder are eligible for this registry. Participants receive or have previously received routine care involving assistive devices, therapeutic services, medications, nutritional support, or respiratory support. They are recruited through specialized outpatient clinics, neurological clinics, university outpatient departments, authorized outpatient centers, and specialist practices participating in the registry in Germany.
Key inclusion criteria (2 listed)
- Patients aged 18 and over
- Diagnosis of amyotrophic lateral sclerosis (ALS), spinal muscular atrophy (SMA), or another motor system disorders
Key exclusion criteria (2 listed)
- Inability or unwillingness to provide informed consent
- Withdrawal of informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of Care (Investigator Choice)This is a non-interventional patient registry. No investigational treatment, procedure, or care strategy is assigned. Participants continue to receive routine care determined by their treating health care professionals. The registry collects historical, current, and future routine-care data from medical records, questionnaires, and, with explicit consent, data exported from software or mobile applications such as the ALS App or SMA App. These applications are not tested or evaluated as interventions in this study. Data may cover medical history, disease course, functional status, medications, assistive devices, therapeutic services, respiratory and nutritional support, and nursing care. | Other | – |
Primary outcome
Number and Percentage of Participants Receiving Each Type of Routine Care Intervention at Enrollment
Time frame: At enrollment
The number and percentage of participants receiving assistive devices, therapeutic services, respiratory support, nutritional support, medication, and nursing care at the time of enrollment will be reported.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
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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.
Marie-Therese Henke contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ALS (Amyotrophic Lateral Sclerosis) and SMA - Spinal Muscular Atrophy, run by Ambulanzpartner Soziotechnologie APST GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. 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: looking for participants now, as of the sponsor's last update on 28 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 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie-Therese Henke (m.henke@ambulanzpartner.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and Percentage of Participants Receiving Each Type of Routine Care Intervention at Enrollment (time frame: At enrollment). 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 28 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.