Clinical Characteristics, Natural History, Health Care Measures, and Genetic Screening in Patients With ALS

Plain-language summary

This observational study examined the clinical characteristics, natural history, health care needs, and genetic screening in patients with amyotrophic lateral sclerosis (ALS). It enrolled patients aged 18 and over with classical ALS, progressive muscular atrophy, or primary lateral sclerosis, and assessed variants in the SOD1, C9orf72, FUS, and TARDBP genes. It was a study without an assigned phase and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Completed

Sponsor

Ambulanzpartner Soziotechnologie APST GmbH

Start date

8/1/2021

Estimated completion

12/31/2024

Countries

Germany

Related genes

Locations

• Berlin, Germany

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* ALS, including classical ALS, Progressive Muscle atrophy (PMA) or Primary Lateral Sclerosis (PLS)
* Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) under national and local subject privacy regulations
* Age of 18 years old at the time of informed consent

Exclusion Criteria:

* Inability to provide patient directives about the notification of individual study results on genetic variants of SOD1, C9orf72, FUS and TARDBP
* Inability to comply with study requirements
* Unspecified reasons that, in the opinion of the site investigator, perceive the subject as unsuitable for enrollment