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Not yet recruitingNCT06740656Updated Feb 18, 2025

Neuromuscular Complications of MEK Inhibitors: a French Case Series and a Systematic Review of the Literature

An observational study in Myositis, Myasthaenia Gravis and Neuropathy, sponsored by Central Hospital, Nancy, France. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-18.

Sponsored by Central Hospital, Nancy, France · Observational

From the registry’s dates

  • Primary completion was expected by Jan 2026, 9 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
5
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Myositis
  • Myasthaenia Gravis
  • Neuropathy
  • Guillain Barré Syndrome
  • Parsonage Turner Syndrome
03

In context

Myositis

242 studies on the registry are indexed under Myositis; 103 are open to participants now.

This study's planned enrollment of 5 is below the median of 226 across 72 observational studies indexed under Myositis.

Browse Myositis studies →

Lead sponsor

Central Hospital, Nancy, France is the lead sponsor of 778 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with neuromuscular complications treated with MEK inhibitors at a Neuromuscular Reference Center in France

Inclusion criteria

  • Patients with neuromuscular complications of MEK inhibitors used alone or in combination
  • Age > 18 years

Exclusion criteria

Exclusion Criteria:

  • Refusal of data collection
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
5 participants (estimated)
Patient registry
No

Interventions

  • OtherNo Interventions

    no intervention

06

What researchers measure

Primary outcomes

  1. Type of neuromuscular complications

    Time frame: up to 8 years

Secondary outcomes

  1. Time to onset after introduction of MEK inhibitors

    Time frame: up to 8 years

  2. Severity of neuromuscular complications

    Time frame: up to 8 years

  3. Progression with or without treatment

    Time frame: up to 8 years

  4. Reintroduction of MEK inhibitors

    Time frame: up to 8 years

07

Study locations

1 site
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06740656
Lead sponsor
Central Hospital, Nancy, France
Responsible party
Pauline DUCATEL (Doctor, Central Hospital, Nancy, France) — Principal investigator
First posted
Dec 18, 2024
Start date
Mar 1, 2025 (estimated)
Primary completion
Jan 1, 2026 (estimated)
Completion
Jan 1, 2026 (estimated)
Last update
Feb 18, 2025

Study contacts

Pauline Ducatel, Doctor
Contact
p.ducatel@chru-nancy.fr
+330383851688
Pauline Ducatel, Doctor
principal investigator · CHRU Nancy

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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