NCT06878235

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
8mo left

Started Apr 2025

Geographic Reach
1 country

7 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress62%
Apr 2025Jan 2027

First Submitted

Initial submission to the registry

March 10, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 14, 2025

Completed
28 days until next milestone

Study Start

First participant enrolled

April 11, 2025

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

1.7 years

First QC Date

March 10, 2025

Last Update Submit

April 29, 2026

Conditions

Lateral Sclerosis

Keywords

Scale

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Change Global Impression (CGI) scale

    6 months

Study Arms (1)

Patients with a primary lateral sclerosis

Other: Assessment of the functional status

Interventions

Assessment of the functional statusOTHER

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

Patients with a primary lateral sclerosis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with primary lateral sclerosis

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

University hospital

Brest, 29000, France

Location

University hospital

Clermont-Ferrand, 63000, France

Location

University hospital

Lille, 59000, France

Location

University hospital

Limoges, 87000, France

Location

University hospital

Lyon, 69000, France

Location

University Hospital

Nice, 05000, France

Location

University hospital

Tours, 37044, France

Location

MeSH Terms

Conditions

Motor Neuron Disease

Condition Hierarchy (Ancestors)

Neurodegenerative DiseasesNervous System DiseasesNeuromuscular Diseases

Study Officials

  • Philippe CORCIA, PR

    University Hospital, Tours

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2025

First Posted

March 14, 2025

Study Start

April 11, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

May 6, 2026

Record last verified: 2026-04

Locations

FR(7)