Myasthenia GravisNCT06860347
Biomarkers for Fatigue in Patients with Myasthenia Gravis
An observational study of Myasthenia Gravis, run by Leiden University Medical Center at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myasthenia Gravis
- How many people
- 115 participants
- Where
- 1 siteNetherlands
- Study dates
- 19 May 2022to 1 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Myasthenia Gravis recruited after previous participation in the cross-sectional fatigue survey study (P15.287).
Who may be able to join
- 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
Who cannot join
- 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.
- The use of anticoagulants therapy.
- Allergy for lidocaine
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Leiden University Medical Center
Leiden, South Holland, 2333ZA
About this study
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.
Read more
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
- Conditions
- Myasthenia Gravis
- Medical subject headings
- Myasthenia Gravis
What is being measured
The primary outcome is the main question the study is designed to answer.
blood biomarker
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.
Measured: 2022
Secondary outcomes (1)
Brain muscle axis
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
Measured: 2022-2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start19 May 2022
- Primary completion1 Sep 2022
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Myasthenia GravisStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martijn R. Tannemaat, MD PhD, Leiden University Medical Center
- Investigators
- Martijn Tannemaat, MD, PhD, Principal investigator, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06860347
- Sponsor's protocol ID
- NL72266.058.20
- Status last verified
- Mar 2025
- First submitted
- 3 Aug 2022
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ruiter AM, Verschuuren JJGM, Tannemaat MR. Prevalence and associated factors of fatigue in autoimmune myasthenia gravis. Neuromuscul Disord. 2021 Jul;31(7):612-621. doi: 10.1016/j.nmd.2021.04.002. Epub 2021 Apr 24.
PubMed 34034925Ruiter AM, Verschuuren JJGM, Tannemaat MR. Fatigue in patients with myasthenia gravis. A systematic review of the literature. Neuromuscul Disord. 2020 Aug;30(8):631-639. doi: 10.1016/j.nmd.2020.06.010. Epub 2020 Jul 1.
PubMed 32718868
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers for Fatigue in Patients with Myasthenia Gravis
- ClinicalTrials.gov ID
- NCT06860347
- Acronym / sponsor ID
- NL72266.058.20
- Conditions
- Myasthenia Gravis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- 19 May 2022 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 6 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Myasthenia Gravis recruited after previous participation in the cross-sectional fatigue survey study (P15.287).
Key inclusion criteria (5 listed)
- Male of female patients aged ≥ 18 years
- Subjects must understand the requirements of the study and provide written informed consent.
- Diagnosis of MG:
Key exclusion criteria (5 listed)
- 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.
- The use of anticoagulants therapy.
- Allergy for lidocaine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Brain muscle axis
Time frame: 2022-2023
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Background: PubMed 34034925Ruiter AM, Verschuuren JJGM, Tannemaat MR. Prevalence and associated factors of fatigue in autoimmune myasthenia gravis. Neuromuscul Disord. 2021 Jul;31(7):612-621. doi: 10.1016/j.nmd.2021.04.002. Epub 2021 Apr 24.
- Background: PubMed 32718868Ruiter AM, Verschuuren JJGM, Tannemaat MR. Fatigue in patients with myasthenia gravis. A systematic review of the literature. Neuromuscul Disord. 2020 Aug;30(8):631-639. doi: 10.1016/j.nmd.2020.06.010. Epub 2020 Jul 1.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martijn Tannemaat, MD, PhD principal investigator
Leiden University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myasthenia Gravis, run by Leiden University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood biomarker (time frame: 2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06860347, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.