In short
Clinical trials are investigating Lucerastat in adults with Fabry disease. These studies aim to assess long-term safety and tolerability, along with treatment effects in the target patient group. The trial data below focuses on the study design, phase, enrollment, and outcome measures.
Key points
- Lucerastat is being studied in clinical trials for adults with Fabry disease. The trial data provided describes one Phase 3 interventional study with 103 planned participants. The main goal is to assess long-term safety and tolerability. The primary outcome focuses on treatment-emergent adverse events and serious adverse events. The study status is listed as authorised. This means the trial has been approved to move forward.
Trial overview
The provided trial record describes an interventional study of Lucerastat in adults with Fabry disease. The study title says it is designed to determine the long-term safety and tolerability of oral Lucerastat in this patient group.
Who can participate
This trial is listed for adult subjects with Fabry disease. The source data does not provide extra selection details, such as age limits beyond adulthood or other entry rules.
What is being measured
The main primary outcome is treatment-emergent adverse events and serious adverse events. In simple terms, the study is watching for new health problems or serious side effects that appear after treatment starts.
Trial design and phase
The study is a Phase 3 trial. Phase 3 studies are later-stage trials that usually involve more participants and help researchers learn more about safety and the overall effect of a treatment in a defined patient group.
The trial uses oral Lucerastat and lists a dose of 2000 mg by mouth in the intervention field. The source material does not ask this article to explain dosing in detail, so the key point is that the study is testing an oral form in the trial setting.
Study status and enrollment
The trial status is listed as Authorised, which means it has been approved to proceed. The planned enrollment is 103 participants.
Only one trial record was provided, so the article reflects the available evidence about Lucerastat clinical research in Fabry disease.