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Global FKRP Registry

Global FKRP Registry

Recruiting
All
Phase N/A

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Overview

Mutations in the Fukutin Related Protein (FKRP) gene cause the condition Limb Girdle Muscular Dystrophy type R9 (LGMDR9) also known as LGMD2I, and the rarer conditions Congenital Muscular Dystrophy (MDC1C), Muscle Eye Brain Disease (MEB) and Walker-Warburg Syndrome (WWS). LGMDR9 is the most common FKRP-related condition, and is especially prevalent in Northern Europe.

The aim is to facilitate a questionnaire based research study in order to better characterise and understand the disease globally. By maintaining a global registry this will help identify potential participants eligible for clinical trials in the future.

Description

The Global FKRP Registry (https://www.fkrp-registry.org/) is an international registry for patients with an FKRP-related condition; no experimental intervention is involved. Patients will receive information on the most up to date standards of care relating to their disease and may be invited to participate in relevant clinical trials. Their data will be updated annually and stored indefinitely, or until they request their data to be removed.

The data will be collected via an online form and will be stored on a secure server based in the United Kingdom and looked after by the registry staff at Newcastle University. Data collected from patients will include demographic information, diagnosis, current condition, age of onset, medication, contractures, family history and results of genetic testing, if available. Other optional questionnaires will focus on patients' pain and quality of life. Further information collected from patients' doctors will include, heart and lung function, muscle strength, muscle and brain MRI findings and genetics.

The FKRP registry is funded by LGMD2i Research Fund and CureLGMD2i.

The primary objectives of the Global FKRP Registry are to:

  • Accelerate and facilitate clinical trials by locating potential research subjects quickly and efficiently
  • Facilitate in the planning of clinical trials
  • Assist the neuromuscular community with the development of recommendations and standards of care
  • Characterise and describe the FKRP population as a whole, enhancing the understanding of the prevalence throughout the world.

Eligibility

Inclusion Criteria:

  • All patients with a confirmed diagnosis of an FKRP-related condition are eligible for inclusion. Diagnosis will be confirmed via genetic testing results.

Exclusion Criteria:

  • There is no exclusion criteria for registration with this patient registry.

Study details
    LGMD2I
    LGMDR9
    Limb Girdle Muscular Dystrophy
    Congenital Muscular Dystrophy
    Muscle-Eye-Brain Disease
    Walker-Warburg Syndrome
    FKRP Gene Mutation

NCT04001595

Newcastle University

16 February 2024

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