Amyotrophic Lateral Sclerosis &Amp; Other Neuromuscular DisordersPALSNCT07091799
Interest of Measuring P2X4 Receptors on Blood Monocytes as a Diagnostic Marker in Amyotrophic Lateral Sclerosis: P2X4 as a Diagnostic Biomarker for ALS
A study testing P2X4 receptors in blood samples in people with Amyotrophic Lateral Sclerosis &Amp; Other Neuromuscular Disorders, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Amyotrophic lateral sclerosis (ALS) is the most common form of motor neuron disease and is characterized by the degeneration of motor neurons leading to progressive paralysis and death within 3 to 5 years after diagnosis. To date, no key mechanism had been identified. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Amyotrophic Lateral Sclerosis &Amp; Other Neuromuscular Disorders
- What is being tested?
- P2X4 receptors in blood samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jan 2026to Jul 2027
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For ALS group: Person presenting a probable or confirmed diagnosis of ALS according to the criteria of EI Escorial.
- Adult.
- Person affiliated or beneficiary of a social security scheme.
- Free, informed and written consent signed by the participant or by a third person (in case of physical incapacity of the participant), after information on the study.
Who cannot join
- People undergoing immunosuppressive or corticosteroid treatments.
- Participation in a research protocol with an experimental treatment.
- People placed under guardianship, curatorship or legal protection.
- For healthy volunteer, people directly related to the patient (siblings, descendants and ancestry).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Claire Fremy contact
France1 site, 1 recruiting
- Recruiting
Hôpital Pellegrin
Bordeaux, 33000
Gwendal Le Masson, Pr, 05 57 82 13 70 ext. +33, gwendal.le-masson@chu-bordeaux.fr
Claire Fremy, claire.fremy@chu-bordeaux.fr
About this study
Amyotrophic lateral sclerosis (ALS) is the most common form of motor neuron disease and is characterized by the degeneration of motor neurons leading to progressive paralysis and death within 3 to 5 years after diagnosis. To date, no key mechanism had been identified. Our associated laboratory has identified the P2X4 purinergic pathway that appears to be involved in the pathogenesis of ALS. Our goal is to verify these results at the human level in order to have a proof of concept of P2X4's role as a biomarker of the disease.
- Being tested
- P2X4 receptors in blood samples
- Keywords
- P2X4, diagnostic biomarker, purinergic pathway
- 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.
P2X4 receptors in blood samplesDiagnostic test
This is an interventional study designed to assay P2X4 receptors in blood samples from ALS patients and healthy volunteers by comparing the mean levels of P2X4 expression.
| Study group | Role | What they receive |
|---|---|---|
| ALS patient | Experimental | During the inclusion visit on D0, which will take place during a consultation or a hospitalization scheduled as part of the standard of care, patients will be informed about the protocol and their informed consent will be obtained.
A neurological clinical examination will be performed, the ALSFRS-R score will be evaluated, as well as respiratory functional explorations and a standard biology assessment. As part of the research, an additional blood sample will be taken.
For ALS patients, a follow-up visit will be performed at 6 months as part of their follow-up consultation at the ALS center. The same examinations as on D0 will be done. Receives: Diagnostic Test: P2X4 receptors in blood samples |
| Standard : healthy subjects | Other | During the inclusion visit on D0, which will take place during a consultation or a hospitalization scheduled as part of the standard of care. A neurological clinical examination will be performed, the ALSFRS-R score will be evaluated, as well as respiratory functional explorations and a standard biology assessment. As part of the research, an additional blood sample will be taken.
For healthy subjects, a follow-up visit will be performed at 6 months. The same examinations as on D0 will be done. Receives: Diagnostic Test: P2X4 receptors in blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression of P2X4 receptor
Compare expression of P2X4 receptor in ALS patients versus healthy subjects to demonstrate its role as a clinical biomarker of ALS. Comparison will be obtained by labeling and flow cytometer analysis of circulating monocytes.
Measured: 6 months after Day 0
Secondary outcomes (5)
Diagnostic performance
Evaluate the diagnostic performances of P2X4 receptor assay for the diagnosis of ALS, thanks to sensitivity and specificity of this P2X4 receptor assay
Measured: 6 months after Day 0
Prognostic performances
Evaluate prognostic performances of P2X4 receptor assay for the diagnosis of ALS, thanks to sensitivity and specificity of this P2X4 receptor assay
Measured: 6 months after Day 0
P2X4 receptor levels evolution
Describe evolution of P2X4 receptor levels with a new sample at 6 months in the same patients, thanks to the difference in P2X4 receptor expression average in the same ALS patient
Measured: 6 months after Day 0
Levels of P2X4 receptors between patients with familial or sporadic ALS.
Compare expression levels of P2X4 receptors between patients with familial or sporadic ALS, thanks to the difference in P2X4 receptor expression average
Measured: 6 months after Day 0
P2X4 receptor levels of patients with a SOD1 mutation treated with anti-SOD1antisense
Compare surface P2X4 receptor levels of patients with a SOD1 mutation treated with anti-SOD1 antisense (Qalsody®, TOFERSEN), thanks to the difference in P2X4 receptor expression average
Measured: 6 months after Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start15 Jan 2026
- Primary completionJan 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral Sclerosis &Amp; Other Neuromuscular DisordersStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07091799
- Sponsor's protocol ID
- CHUBX 2024/82
- Acronym
- PALS
- Status last verified
- Jan 2026
- First submitted
- 25 Jun 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Measuring P2X4 Receptors on Blood Monocytes as a Diagnostic Marker in Amyotrophic Lateral Sclerosis: P2X4 as a Diagnostic Biomarker for ALS
- ClinicalTrials.gov ID
- NCT07091799
- Acronym / sponsor ID
- PALS / CHUBX 2024/82
- Keywords
- P2X4, diagnostic biomarker, purinergic pathway
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 29 Jul 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.
Amyotrophic lateral sclerosis (ALS) is the most common form of motor neuron disease and is characterized by the degeneration of motor neurons leading to progressive paralysis and death within 3 to 5 years after diagnosis. To date, no key mechanism had been identified. Our associated laboratory has identified the P2X4 purinergic pathway that appears to be involved in the pathogenesis of ALS. Our goal is to verify these results at the human level in order to have a proof of concept of P2X4's role as a biomarker of the disease.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALS patient | Experimental | Diagnostic Test: P2X4 receptors in blood samplesDuring the inclusion visit on D0, which will take place during a consultation or a hospitalization scheduled as part of the standard of care, patients will be informed about the protocol and their informed consent will be obtained. A neurological clinical examination will be performed, the ALSFRS-R score will be evaluated, as well as respiratory functional explorations and a standard biology assessment. As part of the research, an additional blood sample will be taken. For ALS patients, a follow-up visit will be performed at 6 months as part of their follow-up consultation at the ALS center. The same examinations as on D0 will be done. |
| Standard : healthy subjects | Other | Diagnostic Test: P2X4 receptors in blood samplesDuring the inclusion visit on D0, which will take place during a consultation or a hospitalization scheduled as part of the standard of care. A neurological clinical examination will be performed, the ALSFRS-R score will be evaluated, as well as respiratory functional explorations and a standard biology assessment. As part of the research, an additional blood sample will be taken. For healthy subjects, a follow-up visit will be performed at 6 months. The same examinations as on D0 will be done. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- For ALS group: Person presenting a probable or confirmed diagnosis of ALS according to the criteria of EI Escorial.
- Adult.
- Person affiliated or beneficiary of a social security scheme.
- Free, informed and written consent signed by the participant or by a third person (in case of physical incapacity of the participant), after information on the study.
Key exclusion criteria (4 listed)
- People undergoing immunosuppressive or corticosteroid treatments.
- Participation in a research protocol with an experimental treatment.
- People placed under guardianship, curatorship or legal protection.
- For healthy volunteer, people directly related to the patient (siblings, descendants and ancestry).
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 |
|---|---|---|
| P2X4 receptors in blood samplesThis is an interventional study designed to assay P2X4 receptors in blood samples from ALS patients and healthy volunteers by comparing the mean levels of P2X4 expression. | Diagnostic test | ALS patient, Standard : healthy subjects |
Primary outcome
Expression of P2X4 receptor
Time frame: 6 months after Day 0
Compare expression of P2X4 receptor in ALS patients versus healthy subjects to demonstrate its role as a clinical biomarker of ALS. Comparison will be obtained by labeling and flow cytometer analysis of circulating monocytes.
5 secondary outcomes
Diagnostic performance
Time frame: 6 months after Day 0
Prognostic performances
Time frame: 6 months after Day 0
P2X4 receptor levels evolution
Time frame: 6 months after Day 0
Levels of P2X4 receptors between patients with familial or sporadic ALS.
Time frame: 6 months after Day 0
P2X4 receptor levels of patients with a SOD1 mutation treated with anti-SOD1antisense
Time frame: 6 months after Day 0
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 21 Jan 2026.
- Individual participant dataSharing planned: No
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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.
Claire Fremy contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing P2X4 receptors in blood samples in people with Amyotrophic Lateral Sclerosis &Amp; Other Neuromuscular Disorders, run by University Hospital, Bordeaux at 1 site 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 4 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: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Gwendal Le Masson, Pr (05 57 82 13 70 ext. +33, gwendal.le-masson@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expression of P2X4 receptor (time frame: 6 months after Day 0). 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 21 Jan 2026.