Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2025-12-25 @ 8:59 PM
Study NCT ID:
NCT06740656
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-02-18
First Post:
2024-12-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neuromuscular Complications of MEK Inhibitors: a French Case Series and a Systematic Review of the Literature
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009220', 'term': 'Myositis'}, {'id': 'D020275', 'term': 'Guillain-Barre Syndrome'}, {'id': 'D020968', 'term': 'Brachial Plexus Neuritis'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D011129', 'term': 'Polyradiculoneuropathy'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D011115', 'term': 'Polyneuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D000094025', 'term': 'Post-Infectious Disorders'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020516', 'term': 'Brachial Plexus Neuropathies'}, {'id': 'D009443', 'term': 'Neuritis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-16', 'studyFirstSubmitDate': '2024-12-08', 'studyFirstSubmitQcDate': '2024-12-14', 'lastUpdatePostDateStruct': {'date': '2025-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Type of neuromuscular complications', 'timeFrame': 'up to 8 years'}], 'secondaryOutcomes': [{'measure': 'Time to onset after introduction of MEK inhibitors', 'timeFrame': 'up to 8 years'}, {'measure': 'Severity of neuromuscular complications', 'timeFrame': 'up to 8 years'}, {'measure': 'Progression with or without treatment', 'timeFrame': 'up to 8 years'}, {'measure': 'Reintroduction of MEK inhibitors', 'timeFrame': 'up to 8 years'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myositis', 'Myasthaenia Gravis', 'Neuropathy', 'Guillain Barré Syndrome', 'Parsonage Turner Syndrome']}, 'descriptionModule': {'briefSummary': '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.\n\nWith 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.\n\nYet, so far, these complications have only been documented in a few single case reports.\n\nOur aim was to characterize the neuromuscular complications associated with MEK inhibitors used either alone or in combination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with neuromuscular complications treated with MEK inhibitors at a Neuromuscular Reference Center in France', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with neuromuscular complications of MEK inhibitors used alone or in combination\n* Age \\> 18 years\n\nExclusion Criteria:\n\n* Refusal of data collection'}, 'identificationModule': {'nctId': 'NCT06740656', 'briefTitle': 'Neuromuscular Complications of MEK Inhibitors: a French Case Series and a Systematic Review of the Literature', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Neuromuscular Complications of MEK Inhibitors: a French Case Series and a Systematic Review of the Literature', 'orgStudyIdInfo': {'id': '2024PI240'}}, 'armsInterventionsModule': {'interventions': [{'name': 'No Interventions', 'type': 'OTHER', 'description': 'no intervention'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nancy', 'country': 'France', 'contacts': [{'name': 'Dr Ducatel', 'role': 'CONTACT', 'email': 'p.ducatel@chru-nancy.fr', 'phone': '03.83.85.16.88'}], 'facility': 'CHRU Nancy', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}], 'centralContacts': [{'name': 'Pauline Ducatel, Doctor', 'role': 'CONTACT', 'email': 'p.ducatel@chru-nancy.fr', 'phone': '+330383851688'}], 'overallOfficials': [{'name': 'Pauline Ducatel, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHRU Nancy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Pauline DUCATEL', 'investigatorAffiliation': 'Central Hospital, Nancy, France'}}}}