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Lucerastat

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.

Table of Contents

Trial overview

The provided trial record describes an interventional study of Lucerastat in adults with Fabry disease.[1] The study title says it is designed to determine the long-term safety and tolerability of oral Lucerastat in this patient group.[1]

Who can participate

This trial is listed for adult subjects with Fabry disease.[1] The source data does not provide extra selection details, such as age limits beyond adulthood or other entry rules.[1]

What is being measured

The main primary outcome is treatment-emergent adverse events and serious adverse events.[1] In simple terms, the study is watching for new health problems or serious side effects that appear after treatment starts.[1]

Trial design and phase

The study is a Phase 3 trial.[1] 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.[1]

The trial uses oral Lucerastat and lists a dose of 2000 mg by mouth in the intervention field.[1] 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.[1]

Study status and enrollment

The trial status is listed as Authorised, which means it has been approved to proceed.[1] The planned enrollment is 103 participants.[1]

Only one trial record was provided, so the article reflects the available evidence about Lucerastat clinical research in Fabry disease.[1]

Trial ID Phase Condition studied Status Enrollment
NCT03737214 Phase 3 Fabry disease Authorised 103

FAQ

  • What is being studied in Lucerastat clinical trials? The trial data shows that Lucerastat is being studied in adults with Fabry disease. The main goal is to check long-term safety and tolerability.
  • Who can take part in the Lucerastat trial listed here? The listed study includes adult subjects with Fabry disease. The trial description does not give more detailed eligibility rules in the provided data.
  • What phase is the Lucerastat trial? The trial is a Phase 3 study. Phase 3 trials usually test a treatment in a larger group of people to better understand its effects and safety.
  • What condition is Lucerastat being studied for in this trial? Lucerastat is being studied for Fabry disease. Fabry disease is the condition named in the trial record.
  • What outcome is the trial measuring? The main outcome is treatment-emergent adverse events and serious adverse events. These are new side effects or serious medical problems that happen after treatment starts.

Ongoing Clinical Trials on Lucerastat

  • Study on Long-Term Safety of Oral Lucerastat for Adults with Fabry Disease

    Not recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium France Germany Norway Poland +1

Glossary

  • Fabry disease: A genetic condition named in the trial record. The study is testing Lucerastat in adults who have this disease.
  • Adult subjects: People who are 18 years old or older. This trial is not listed for children.
  • Phase 3: A later stage of clinical testing. Phase 3 studies usually include more people and look more closely at how well a treatment works and how safe it is.
  • Interventional study: A type of clinical trial where researchers give a treatment and then measure what happens.
  • Long-term safety: How safe a treatment is when it is used over a longer period of time.
  • Tolerability: How well people can take a treatment without having too much trouble from side effects or other problems.
  • Treatment-emergent adverse events: Medical problems or side effects that start or get worse after treatment begins.
  • Serious adverse events: Important medical problems that are severe, life-threatening, or need urgent care.
  • Enrollment: The number of people planned or included in a study.
  • Authorised: The study has been approved to take place.

References