NCT05852418

Brief 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. The data collected should describe the clinical practice, meaning real-world evidence and patient-reported outcomes.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25,000

participants targeted

Target at P75+ for all trials

Timeline
37mo left

Started Oct 2015

Longer than P75 for all trials

Geographic Reach
1 country

16 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
Oct 2015Jun 2029

Study Start

First participant enrolled

October 30, 2015

Completed
7.5 years until next milestone

First Submitted

Initial submission to the registry

April 28, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 10, 2023

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2029

Last Updated

January 29, 2025

Status Verified

January 1, 2025

Enrollment Period

13.2 years

First QC Date

April 28, 2023

Last Update Submit

January 28, 2025

Conditions

Amyotrophic Lateral Sclerosis

Keywords

ALS Registry studySMA Registry studyALS medication and care registry studySMA medication and care registry studyNfLNeurofilament light chainALSFRS-RALS-AppALSAPST ResearchBiomarkerTofersenNusinersenRisdiplam

Outcome Measures

Primary Outcomes (1)

  • 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

    10 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Christoph Münch

Berlin, 13353, Germany

RECRUITING

Neurologische Klinik und Poliklinik, Universitätsklinikum Bergmannsheil

Bochum, Germany

RECRUITING

Klinik für Neurodegenrative Erkrankungen und Gerontopsychiatrie, ALS-Ambulanz und Huntington Ambulanz, Universitätsklinikum

Bonn, Germany

RECRUITING

Klinik und Poliklinik für Neurologie, Medizinische Fakultät Carl Gustav Carus, Technischen Universität Dresden

Dresden, Germany

RECRUITING

Neurologische Klinik, ALS-Ambulanz, Alfried Krupp Krankenhaus Rüttenscheid, Essen

Essen, Germany

RECRUITING

Klinik für Neurologie, Universitätsmedizin, Georg-August-Universität Göttingen

Göttingen, Germany

RECRUITING

ALS- und Muskelambulanz, Medizinische Hochschule Hannover

Hanover, Germany

RECRUITING

Neurologie und Poliklinik, Universitätsklinikum

Heidelberg, Germany

RECRUITING

Ambulanz für Neuromuskuläre und Motoneuron-Erkrankungen, Universitätsklinikum Jena

Jena, Germany

RECRUITING

Klinik und Poliklinik für Neurologie

Leipzig, Germany

RECRUITING

Klinik für Neuroogie-Präzisionsneurologie, Universitätsklinikum Schleswig-Holstein, Universität zu Lübeck

Lübeck, Germany

RECRUITING

Neurologisches Klinik, Ambulanz für Motoneuronerkrankungen und ALS, Diakonissenkrankenhaus

Mannheim, Germany

RECRUITING

Universitätklinikum

Mannheim, Germany

RECRUITING

Klinik und Poliklinik für Neurologie, Klinikum rechts der Isar der Technischen Universität München

München, Germany

RECRUITING

Klinik für Schlafmedizin und Neuromuskuläre Erkrankungen, Westfälische Willhelms-Universität Münster

Münster, Germany

RECRUITING

Klinik für Innere Medizin, Neurologie, UKM Marienhospital Steinfurt

Steinfurt, Germany

RECRUITING

MeSH Terms

Conditions

Amyotrophic Lateral SclerosisCharcot-Marie-Tooth disease, Type 1F

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesMotor Neuron DiseaseNeurodegenerative DiseasesTDP-43 ProteinopathiesNeuromuscular DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Thomas Meyer, Prof. Dr.

    Ambulanzpartner Soziotechnologie APST GmbH

    STUDY DIRECTOR

Central Study Contacts

Thomas Meyer, Prof. Dr.

CONTACT

t.meyer@ambulanzpartner.de

Senthil Kumar Subramanian, Dr.

CONTACT

+4930810314118sk.subramanian@ambulanzpartner.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2023

First Posted

May 10, 2023

Study Start

October 30, 2015

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

June 1, 2029

Last Updated

January 29, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

DE(16)