Validation of the French Version of the Primary Lateral S... | NCT06878235

Studies
Validation of the French Version of the Primary Lateral Sclerosis Functioning Rating Scale (PLSFRS)

NCT06878235

Sponsor

University Hospital, Tours

Status

Active, not recruiting

Last Update Posted

May 6, 2026Actual

Enrollment

80Estimated

Phase

Not provided

Conditions

Lateral Sclerosis

Interventions

Assessment of the functional status

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 11, 2025Actual

Primary Completion Date

Jan 2027Estimated

Completion Date

Jan 2027Estimated

First Submitted Date

Mar 10, 2025

First Submission Date that Met QC Criteria

Mar 10, 2025

First Posted Date

Mar 14, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 29, 2026

Last Update Posted Date

May 6, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a national, multicentric, prospective, descriptive study evaluating the psychometric properties of the French version PLSFRS scale

Detailed Description

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with a primary lateral sclerosis			Other: Assessment of the functional status

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Assessment of the functional status	Other	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
French version of the PLSFRS scale	10 items with a score from 0 to 6; 2 items with a score from 0 to 4 Maximal score is 68.	inclusion and 6 months

Secondary Outcomes

Measure	Description	Time Frame
Change Global Impression (CGI) scale	overall clinical impression of the change; score from 1 to 7	6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with primary lateral sclerosis (PLS)
Age over 18 years
Informed consent signed
Patients cared in a French ALS centre

Exclusion Criteria:

patients with no oral and written command of the French language
Patients unable to answer a questionnaire
Opposition to data processing

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult patients with primary lateral sclerosis

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Philippe CORCIA, PR	University Hospital, Tours	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University hospital		Brest		29000	France
University hospital

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016472	Motor Neuron Disease

Ancestor Terms

ID	Term
D019636	Neurodegenerative Diseases
D009422	Nervous System Diseases
D009468	Neuromuscular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided