Biomarkers for Fatigue in Patients with Myasthenia Gravis

March 4, 2025 updated by: Martijn R. Tannemaat, MD PhD, Leiden University Medical Center

Rationale: Myasthenia Gravis (MG) is a chronic autoimmune disease affecting the neuromuscular junction. Although a hallmark of MG is muscle fatigability due to dysfunction of the neuromuscular junction (peripheral fatigue), a large number of MG patients also report symptoms of central or cognitive fatigue. Central fatigue is defined as an experienced lack of energy, physically and/or mentally. In October 2019 we performed a cross-sectional survey study (P15.287) among 420 Dutch MG patients showing a clinically relevant central fatigue rate of 62% on the Checklist Individual Strength-Fatigue subscale (CIS-f). In this prior study, we identified a number of factors associated with fatigue, but these factors cannot fully explain the observed high prevalence of fatigue in MG and very little is known on its biological substrates and pathophysiology.

Objectives: The main objective is to investigate if there are biomarkers for fatigue in MG. The secondary objective is to investigate the muscle origin of these biomarkers.

Study design: This study will be an exploratory study, subdivided in part I and part II (optional).

Study population: Patients with Myasthenia Gravis recruited after previous participation in the cross-sectional fatigue survey study (P15.287).

Intervention:

Phase I:

Visit 1, time: 0

  • blood withdrawal
  • muscle biopsy (not mandatory for participation)
  • QMG
  • questionnaires on medication, disease severity, fatigue, depressive symptoms and physical condition

Phase II (optional):

Visit 2, time: 6-12 months after visit 1, after analysis of phase I results.

  • blood withdrawal (similar analysis as phase I)
  • QMG
  • questionnaires on medication, disease severity, fatigue, depressive symptoms and physical condition

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

115

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Zuid-Holland
      • Leiden, Zuid-Holland, Netherlands, 2333ZA
        • Leiden University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with Myasthenia Gravis recruited after previous participation in the cross-sectional fatigue survey study (P15.287).

Description

Inclusion Criteria:

  • Male of female patients aged ≥ 18 years
  • Subjects must understand the requirements of the study and provide written informed consent.

  • Diagnosis of MG:

    • Clinical signs or symptoms characteristic for MG and
    • A positive serologic test for AChR antibodies

Exclusion Criteria:

A medical history of other active auto-immune disorders for which the patient currently receives a medical treatment, such as thyroid disease or rheumatoid arthritis.

  • A medical history of neoplasms within the last year.
  • Substance abuse.

Exclusion criteria for muscle biopsy

  • The use of anticoagulants therapy.
  • Allergy for lidocaine

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
blood biomarker
Time Frame: 2022
To investigate whether there is a potential biomarker, which corresponds with fatigue in MG, among the biomarkers that were previously identified in other disorders. For this objective we aim to determine and compare the diagnostic yield of several serum biomarkers which were (possibly) associated with central fatigue in other disorders in previous studies.
2022

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brain muscle axis
Time Frame: 2022-2023
To investigate whether a potential biomarker, which corresponds with fatigue in MG, is derived from muscle tissue. Therefore, we will assess the expressed mRNA in skeletal muscle tissue to confirm the muscle origin of elevated circulating serum biomarkers
2022-2023

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Leiden University Medical Center

Investigators

  • Principal Investigator: Martijn Tannemaat, MD, PhD, Leiden University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 19, 2022

Primary Completion (Actual)

September 1, 2022

Study Completion (Actual)

April 1, 2023

Study Registration Dates

First Submitted

August 3, 2022

First Submitted That Met QC Criteria

March 4, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 4, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL72266.058.20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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