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NCT Number: NCT06740656

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

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.

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Key information

Conditions

Myositis Autoimmune Diseases Autoimmune Diseases of the Nervous System Brachial Plexus Neuritis Brachial Plexus Neuropathies Chronic Disease Demyelinating Diseases Disease Attributes Guillain Barré Syndrome Guillain-Barre Syndrome Immune System Diseases Muscular Diseases Musculoskeletal Diseases Myasthaenia Gravis Nervous System Diseases Neuritis Neuromuscular Diseases Neuropathy Parsonage Turner Syndrome Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Polyneuropathies Polyradiculoneuropathy Post-Infectious Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Refusal of data collection

Treatment and study plan

No interventions

Other

no intervention

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

Study contacts

Contact information is provided by the study sponsor or research team.

Pauline Ducatel, Doctor

CONTACT

[email protected]

+330383851688

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 18, 2024
Registry last updated
Feb 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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