NCT04773470Completed
Implementation of FEES in Spinal Muscle Atrophy
Implementation of Flexible Endoscopic Evaluation of Swallowing (FEES) and Standardized FEES Scores in the Diagnostic Work-up of Dysphagia in Spinal Muscular Atrophy - DYS-SMA Trial
Source: ClinicalTrials.gov · Last updated 10 Dec 2025
Brief summary (registry, in English)
The major aim of this project is to assess comprehensively frequency and extent of dysphagia and bulbar dysfunction in SMA1, 2, and 3 patients by applying FEES and validated dysphagia scores. Further aims are to follow changes of dysphagia over time in newly diagnosed patients, and in subjects starting treatment with one of the new therapeutic SMA drugs. Special attention will be paid to subjects treated with Risdiplam. If applicable, the data will be compared between groups receiving different drugs.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 79 (actual)
- First submitted
- 19 Nov 2020
- Start date
- 1 Feb 2022
- Primary completion date
- 1 Sept 2024
- Lead sponsor
- University of Giessen
- Diseases
- Spinal muscular atrophy
- NCT number
- NCT04773470
What you commit to
- Study type: Interventional
- Participants enrolled: 79
- From 1 Feb 2022 to the primary completion date, 1 Sept 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Physical illness that, according to its type and severity, could interfere with the planned assessments, could have an influence on the parameters to be investigated or could endanger the patient or test person during the course of the investigation.
- Poor general condition
Other
- Pregnancy or lactation and a positive pregnancy test
- Acute suicidal tendency or external danger
Who the study is looking for
- All patients with genetically determined 5q-linked SMA followed at the neuromuscular center Gießen
- \- Informed and written consent signed by the patient or a legal guardian
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Giessen and Marburg, Campus Giessen Coordinator of this site? Confirm its status | Giessen | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.