MyositisNCT06740656
Neuromuscular Complications of MEK Inhibitors: a French Case Series and a Systematic Review of the Literature
An observational study of Myositis and Myasthaenia Gravis, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
MEK inhibitors (trametinib, cobimetinib, selumetinib or binimetinib) have been used since 2016 to treat metastatic melanoma, by targeting the MAPK pathway Neuromuscular complications (neuropathy, myasthenia or myositis) have been reported in patients treated with MEK inhibitors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myositis, Myasthaenia Gravis, Neuropathy
- How many people
- 5 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2025to 1 Jan 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 neuromuscular complications treated with MEK inhibitors at a Neuromuscular Reference Center in France
Who may be able to join
- Patients with neuromuscular complications of MEK inhibitors used alone or in combination
- Age > 18 years
Who cannot join
- Refusal of data collection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
CHRU Nancy
Nancy
Dr Ducatel, 03.83.85.16.88, p.ducatel@chru-nancy.fr
About this study
MEK inhibitors (trametinib, cobimetinib, selumetinib or binimetinib) have been used since 2016 to treat metastatic melanoma, by targeting the MAPK pathway Neuromuscular complications (neuropathy, myasthenia or myositis) have been reported in patients treated with MEK inhibitors.
With the growing use of these new oncology therapies, neurologists, oncologists and other clinicians are likely to be increasingly confronted with MEK inhibitor-induced neuropathy, myasthenia or myositis.
Yet, so far, these complications have only been documented in a few single case reports.
Our aim was to characterize the neuromuscular complications associated with MEK inhibitors used either alone or in combination.
- Conditions
- Myositis, Myasthaenia Gravis, Neuropathy, Guillain Barré Syndrome, Parsonage Turner Syndrome
- Being tested
- No Interventions
- Medical subject headings
- Myositis, Guillain-Barre Syndrome, Brachial Plexus Neuritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionsOther
no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Type of neuromuscular complications
Measured: up to 8 years
Secondary outcomes (4)
Time to onset after introduction of MEK inhibitors
Measured: up to 8 years
Severity of neuromuscular complications
Measured: up to 8 years
Progression with or without treatment
Measured: up to 8 years
Reintroduction of MEK inhibitors
Measured: up to 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start1 Mar 2025 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyositisStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pauline DUCATEL, Central Hospital, Nancy, France
- Investigators
- Pauline Ducatel, Doctor, Principal investigator, CHRU Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06740656
- Sponsor's protocol ID
- 2024PI240
- Status last verified
- Dec 2024
- First submitted
- 8 Dec 2024
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromuscular Complications of MEK Inhibitors: a French Case Series and a Systematic Review of the Literature
- ClinicalTrials.gov ID
- NCT06740656
- Acronym / sponsor ID
- 2024PI240
- Conditions
- Myositis, Myasthaenia Gravis, Neuropathy, Guillain Barré Syndrome, Parsonage Turner Syndrome
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 18 Dec 2024 (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.
MEK inhibitors (trametinib, cobimetinib, selumetinib or binimetinib) have been used since 2016 to treat metastatic melanoma, by targeting the MAPK pathway Neuromuscular complications (neuropathy, myasthenia or myositis) have been reported in patients treated with MEK inhibitors.
With the growing use of these new oncology therapies, neurologists, oncologists and other clinicians are likely to be increasingly confronted with MEK inhibitor-induced neuropathy, myasthenia or myositis.
Yet, so far, these complications have only been documented in a few single case reports.
Our aim was to characterize the neuromuscular complications associated with MEK inhibitors used either alone or in combination.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with neuromuscular complications treated with MEK inhibitors at a Neuromuscular Reference Center in France
Key inclusion criteria (2 listed)
- Patients with neuromuscular complications of MEK inhibitors used alone or in combination
- Age > 18 years
Key exclusion criteria (1 listed)
- Refusal of data collection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Interventionsno intervention | Other | – |
Primary outcome
Type of neuromuscular complications
Time frame: up to 8 years
4 secondary outcomes
Time to onset after introduction of MEK inhibitors
Time frame: up to 8 years
Severity of neuromuscular complications
Time frame: up to 8 years
Progression with or without treatment
Time frame: up to 8 years
Reintroduction of MEK inhibitors
Time frame: up to 8 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
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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.
Pauline Ducatel, Doctor principal investigator
CHRU Nancy
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 Myositis and Myasthaenia Gravis, run by Central Hospital, Nancy, France at 1 site in France.
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 2 inclusion and 1 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: opening soon, as of the sponsor's last update on 18 Feb 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pauline Ducatel, Doctor (+330383851688, p.ducatel@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Type of neuromuscular complications (time frame: up to 8 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Feb 2025.