Progressive Motor Neuron Disease Without Definite DiagnosisFILSLAN-NFNCT05077696
Neurofilament Assay for the Diagnosis of ALS
An observational study of Progressive Motor Neuron Disease Without Definite Diagnosis, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
The aim of the study is to evaluate the interest of the determination of pNFH and NFL neurofilaments in serum for the diagnosis of ALS in patients with a diagnostic standoff after evaluation in an expert ALS center. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Progressive Motor Neuron Disease Without Definite Diagnosis
- What is being tested?
- Drawing a tube of blood (serum)
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2021to 1 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Patients with progressive motor neuron disease without a definite diagnosis.
Who may be able to join
- Subjects with first and/or second motor neuron disease, evolving clinically and/or electrically over at least 12 months, not meeting the diagnostic criteria for ALS (revised El Escorial criteria):
- Isolated peripheral motor neuron disease (at least one region of the PNM) OR
- Isolated central motor neuron involvement (at least two areas of the MNC) OR
- associated involvement of the MNP and MNC but in the presence of an associated pathology responsible for a persistent diagnostic doubt (double narrow cervical and lumbar canal, associated evolving cancer evoking a paraneoplastic syndrome without specific antibody found) Age superior to 18 years Management and follow-up in one of the French ALS centers Patient able to express his non-opposition Affiliation with social security or beneficiary of such a plan
- Non-inclusion criteria:
- Refusal of the patient Person under a legal protection measure (guardianship, curatorship or safeguard of justice).
- Person deprived of liberty by judicial or administrative decision.
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Contribution of the Neurofilament Assay for the Diagnosis of ALS (Amyotrophic Lateral Sclerosis) in Situations of Diagnostic Standoff After Evaluation in an Expert ALS Center
The aim of the study is to evaluate the interest of the determination of pNFH and NFL neurofilaments in serum for the diagnosis of ALS in patients with a diagnostic standoff after evaluation in an expert ALS center. The hypothesis is that one of these biomarkers, or their combined analysis, will make it possible to confirm or invalidate the diagnosis of ALS.
Read the detailed description
For this study, which aims to evaluate a test to help in the diagnosis of ALS that could be integrated into routine practice, it was preferred to use blood tests. Blood sampling is significantly less invasive than CSF sampling, and more easily generalized, including in ambulatory conditions.
- Being tested
- Drawing a tube of blood (serum)
- Keywords
- ALS, Neurofilaments, NFL, pNFH, Amyotrophic Lateral Sclerosis, progressive motor neuron disease
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drawing a tube of blood (serum)Other
dosage of neurofilaments and comparison with a final diagnosis one year after sampling.
| Study group | Role | What they receive |
|---|---|---|
| Patients with progressive motor neuron disease without definite diagnosis | Patients with progressive motor neuron disease without definite diagnosis Receives: Other: Drawing a tube of blood (serum) |
What is being measured
The primary outcome is the main question the study is designed to answer.
contribution of pNFH and NFL neurofilaments assays
contribution of pNFH and NFL neurofilaments assays in serum for the positive diagnosis of ALS in a selected population of patients with progressive motor neuron disease without definite diagnosis
Measured: 1 year
Secondary outcomes (1)
Value of the combined pNFH and NFL neurofilament assay in serum versus the pNFH and NFL assay alone
To evaluate the value of the combined pNFH and NFL neurofilament assay in serum versus the pNFH and NFL assay alone for the positive diagnosis of ALS in a selected population of patients with progressive motor neuron disease without a definite diagnosis.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2021
- Study start1 Nov 2021 (estimated)
- Primary completion1 Nov 2023 (estimated)
- Study completion1 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Progressive Motor Neuron Disease Without Definite DiagnosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05077696
- Sponsor's protocol ID
- APHP210917
- Other IDs
- 2021-A02460-41
- Acronym
- FILSLAN-NF
- Status last verified
- Sep 2021
- First submitted
- 1 Oct 2021
- Last updated
- 14 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of the Neurofilament Assay for the Diagnosis of ALS (Amyotrophic Lateral Sclerosis) in Situations of Diagnostic Standoff After Evaluation in an Expert ALS Center
- ClinicalTrials.gov ID
- NCT05077696
- Acronym / sponsor ID
- FILSLAN-NF / APHP210917
- Keywords
- ALS, Neurofilaments, NFL, pNFH, Amyotrophic Lateral Sclerosis, progressive motor neuron disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Nov 2021 (estimated)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 14 Oct 2021 (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.
The aim of the study is to evaluate the interest of the determination of pNFH and NFL neurofilaments in serum for the diagnosis of ALS in patients with a diagnostic standoff after evaluation in an expert ALS center. The hypothesis is that one of these biomarkers, or their combined analysis, will make it possible to confirm or invalidate the diagnosis of ALS.
Detailed description
For this study, which aims to evaluate a test to help in the diagnosis of ALS that could be integrated into routine practice, it was preferred to use blood tests. Blood sampling is significantly less invasive than CSF sampling, and more easily generalized, including in ambulatory conditions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with progressive motor neuron disease without definite diagnosis | – | Other: Drawing a tube of blood (serum)Patients with progressive motor neuron disease without definite diagnosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with progressive motor neuron disease without a definite diagnosis.
Key inclusion criteria (7 listed)
- Subjects with first and/or second motor neuron disease, evolving clinically and/or electrically over at least 12 months, not meeting the diagnostic criteria for ALS (revised El Escorial criteria):
- Isolated peripheral motor neuron disease (at least one region of the PNM) OR
- Isolated central motor neuron involvement (at least two areas of the MNC) OR
- associated involvement of the MNP and MNC but in the presence of an associated pathology responsible for a persistent diagnostic doubt (double narrow cervical and lumbar canal, associated evolving cancer evoking a paraneoplastic syndrome without specific antibody found) Age superior to 18 years Management and follow-up in one of the French ALS centers Patient able to express his non-opposition Affiliation with social security or beneficiary of such a plan
- Refusal of the patient Person under a legal protection measure (guardianship, curatorship or safeguard of justice).
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Drawing a tube of blood (serum)dosage of neurofilaments and comparison with a final diagnosis one year after sampling. | Other | Patients with progressive motor neuron disease without definite diagnosis |
Primary outcome
contribution of pNFH and NFL neurofilaments assays
Time frame: 1 year
contribution of pNFH and NFL neurofilaments assays in serum for the positive diagnosis of ALS in a selected population of patients with progressive motor neuron disease without definite diagnosis
1 secondary outcome
Value of the combined pNFH and NFL neurofilament assay in serum versus the pNFH and NFL assay alone
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2021.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Progressive Motor Neuron Disease Without Definite Diagnosis, run by Assistance Publique - Hôpitaux de Paris.
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 7 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 14 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria del Mar Amador (1 42 16 24 72 ext. +33, mariadelmar.amador@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
contribution of pNFH and NFL neurofilaments assays (time frame: 1 year). 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 14 Oct 2021; AzTrials last refreshed its copy on 8 Nov 2026.