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

NCT06740656 | Not Yet Recruiting

• 1 other identifier: 2024PI240
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Myositis; Myasthaenia Gravis; Neuropathy; Guillain Barré Syndrome; Parsonage Turner Syndrome

Outcome Measures

Primary Outcomes (1)

• Type of neuromuscular complications

  up to 8 years

Secondary Outcomes (4)

• Time to onset after introduction of MEK inhibitors

  up to 8 years

• Severity of neuromuscular complications

  up to 8 years

• Progression with or without treatment

  up to 8 years

• Reintroduction of MEK inhibitors

  up to 8 years

Interventions

No Interventions OTHER

no intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Refusal of data collection

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

CHRU Nancy

Nancy, France

Location

MeSH Terms

Conditions

Myositis; Guillain-Barre Syndrome; Brachial Plexus Neuritis

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Brachial Plexus Neuropathies; Neuritis

Study Officials

• Pauline Ducatel, Doctor

  CHRU Nancy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pauline Ducatel, Doctor

CONTACT

+330383851688; p.ducatel@chru-nancy.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: December 8, 2024
• First Posted: December 18, 2024
• Study Start: March 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: February 18, 2025

Record last verified: 2024-12

Locations

FR (1)