Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-25 @ 7:55 PM
Study NCT ID:
NCT06878235
Status:
RECRUITING
Last Update Posted:
2025-05-29
First Post:
2025-03-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Validation of the French Version of the Primary Lateral Sclerosis Functioning Rating Scale (PLSFRS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016472', 'term': 'Motor Neuron Disease'}], 'ancestors': [{'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-22', 'studyFirstSubmitDate': '2025-03-10', 'studyFirstSubmitQcDate': '2025-03-10', 'lastUpdatePostDateStruct': {'date': '2025-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'French version of the PLSFRS scale', 'timeFrame': 'inclusion and 6 months', 'description': '10 items with a score from 0 to 6; 2 items with a score from 0 to 4 Maximal score is 68.'}], 'secondaryOutcomes': [{'measure': 'Change Global Impression (CGI) scale', 'timeFrame': '6 months', 'description': 'overall clinical impression of the change; score from 1 to 7'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Scale'], 'conditions': ['Lateral Sclerosis']}, 'descriptionModule': {'briefSummary': 'This is a national, multicentric, prospective, descriptive study evaluating the psychometric properties of the French version PLSFRS scale', 'detailedDescription': 'This is a prospective study conducted in 8 French ALS centers which will enroll 80 patients with PLS. All these patients will undergo an evaluation of their functional status from the ALSFRS-r and PLSFRS scales. All patients will be evaluated at 3 time points (T0,M6 at the outpatient clinic) and at M3 remotely. The aim of the study will be to validate a trans-cultural and psychometric version of the PLSFRS available for the French PLS population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with primary lateral sclerosis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with primary lateral sclerosis (PLS)\n* Age over 18 years\n* Informed consent signed\n* Patients cared in a French ALS centre\n\nExclusion Criteria:\n\n* patients with no oral and written command of the French language\n* Patients unable to answer a questionnaire\n* Opposition to data processing'}, 'identificationModule': {'nctId': 'NCT06878235', 'acronym': 'FRENPRILS', 'briefTitle': 'Validation of the French Version of the Primary Lateral Sclerosis Functioning Rating Scale (PLSFRS)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Tours'}, 'officialTitle': 'Validation of the French Version of the PLSFRS Scale', 'orgStudyIdInfo': {'id': 'DR240260-FRENPRILS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with a primary lateral sclerosis', 'interventionNames': ['Other: Assessment of the functional status']}], 'interventions': [{'name': 'Assessment of the functional status', 'type': 'OTHER', 'description': 'assessment of their functional status using the French version of the PLSFRS scale during a routine multidisciplinary assessment every 3-6 months for all patients with motor neurone disease, as recommended by the FILSLAN network', 'armGroupLabels': ['Patients with a primary lateral sclerosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29000', 'city': 'Brest', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Steeve GENESTET, Dr', 'role': 'CONTACT', 'email': 'steeve.genestet@chu-brest.fr', 'phone': '0298347309', 'phoneExt': '+33'}, {'name': 'Steeve Genestet, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University hospital', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '63000', 'city': 'Clermont-Ferrand', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Nathalie GUY, Dr', 'role': 'CONTACT', 'email': 'nguy@chu-clermontferrand.fr', 'phone': '0473752043', 'phoneExt': '+33'}, {'name': 'Nathalie GUY, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University hospital', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '59000', 'city': 'Lille', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Véronique DANEL, Dr', 'role': 'CONTACT', 'email': 'veronique.danel@chru-lille.fr', 'phone': '0320445962', 'phoneExt': '+33'}, {'name': 'Véronique DANEL, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University hospital', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '87000', 'city': 'Limoges', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Philippe COURATIER, Pr', 'role': 'CONTACT', 'email': 'philippe.couratier@chu-limoges.fr', 'phone': '0555056559', 'phoneExt': '+33'}, {'name': 'Philippe COURATIER, Pr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University hospital', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '69000', 'city': 'Lyon', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Emilien BERNARD, Dr', 'role': 'CONTACT', 'email': 'emilien.bernard@chu-lyon.fr', 'phone': '0472357218', 'phoneExt': '+33'}, {'name': 'Emilien BERNARD, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University hospital', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '05000', 'city': 'Nice', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marie-Hélène SORIANI, Dr', 'role': 'CONTACT', 'email': 'soriani.mh@chu-nice.fr', 'phoneExt': '+33'}, {'name': 'Marie-Hélène SORIANI, +33', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '37044', 'city': 'Tours', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Philippe CORCIA, Pr', 'role': 'CONTACT', 'email': 'philippe.corcia@univ-tours.fr', 'phone': '0247473724', 'phoneExt': '+33'}, {'name': 'Philippe Corcia', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University hospital', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}], 'centralContacts': [{'name': 'Philippe CORCIA, Pr', 'role': 'CONTACT', 'email': 'philippe.corcia@univ-tours.fr', 'phone': '0247473724', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Philippe CORCIA, PR', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Tours'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Tours', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}