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
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.
- 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