Menu
Not yet recruiting NCT06740656

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

— Observational Myositis Myasthaenia Gravis Neuropathy Guillain Barré Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: No Interventions.
Who it may be relevant to
Registry conditions: Myositis, Myasthaenia Gravis, Neuropathy, Guillain Barré Syndrome. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Other No Interventions
    no intervention

Primary outcome measures

  • Type of neuromuscular complications [Time frame: up to 8 years]
Secondary outcome measures (4)
  • 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]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • Refusal of data collection

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

France · 1 center
  • CHRU Nancy — Nancy

Identifiers

NCT: NCT06740656 · 2024PI240

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗