Lateral SclerosisFRENPRILSNCT06878235
Validation of the French Version of the Primary Lateral Sclerosis Functioning Rating Scale (PLSFRS)
An observational study of Lateral Sclerosis, run by University Hospital, Tours at 7 sites in France.
Trial summary
This is a national, multicentric, prospective, descriptive study evaluating the psychometric properties of the French version PLSFRS scale Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lateral Sclerosis
- What is being tested?
- Assessment of the functional status
- How many people
- 80 participants
- Where
- 7 sitesFrance
- Study dates
- 11 Apr 2025to Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with primary lateral sclerosis
Who may be able to join
- Patients with primary lateral sclerosis (PLS)
- Age over 18 years
- Informed consent signed
- Patients cared in a French ALS centre
Who cannot join
- patients with no oral and written command of the French language
- Patients unable to answer a questionnaire
- Opposition to data processing
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
University hospital
Brest, 29000
University hospital
Clermont-Ferrand, 63000
University hospital
Lille, 59000
University hospital
Limoges, 87000
University hospital
Lyon, 69000
University Hospital
Nice, 05000
University hospital
Tours, 37044
About this study
Official title: Validation of the French Version of the PLSFRS Scale
This is a national, multicentric, prospective, descriptive study evaluating the psychometric properties of the French version PLSFRS scale
Read the 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.
- Conditions
- Lateral Sclerosis
- Being tested
- Assessment of the functional status
- Keywords
- Scale
- Medical subject headings
- Motor Neuron Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Patients with a primary lateral sclerosis | Not described Receives: Other: Assessment of the functional status |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: inclusion and 6 months
Secondary outcomes (1)
Change Global Impression (CGI) scale
overall clinical impression of the change; score from 1 to 7
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start11 Apr 2025
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral SclerosisStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe CORCIA, PR, Principal investigator, University Hospital, Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06878235
- Sponsor's protocol ID
- DR240260-FRENPRILS
- Acronym
- FRENPRILS
- Status last verified
- Apr 2026
- First submitted
- 10 Mar 2025
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the French Version of the PLSFRS Scale
- ClinicalTrials.gov ID
- NCT06878235
- Acronym / sponsor ID
- FRENPRILS / DR240260-FRENPRILS
- Conditions
- Lateral Sclerosis
- Keywords
- Scale
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 11 Apr 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 14 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with a primary lateral sclerosis | – | Other: Assessment of the functional status |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with primary lateral sclerosis
Key inclusion criteria (4 listed)
- Patients with primary lateral sclerosis (PLS)
- Age over 18 years
- Informed consent signed
- Patients cared in a French ALS centre
Key exclusion criteria (3 listed)
- patients with no oral and written command of the French language
- Patients unable to answer a questionnaire
- Opposition to data processing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment of the functional statusassessment 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 | Other | Patients with a primary lateral sclerosis |
Primary outcome
French version of the PLSFRS scale
Time frame: inclusion and 6 months
10 items with a score from 0 to 6; 2 items with a score from 0 to 4 Maximal score is 68.
1 secondary outcome
Change Global Impression (CGI) scale
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe CORCIA, PR principal investigator
University Hospital, Tours
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lateral Sclerosis, run by University Hospital, Tours at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
French version of the PLSFRS scale (time frame: inclusion and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.