Parkinson DiseaseEarly Phase 1IRIS-CLE-LRRK2NCT05837130
Non-drug Treatment Study in Parkinson's Disease Patients and Healthy Volunteers to Collect Biological Samples in Order to Assess ex Vivo the Activity of Candidate Therapies and Develop Novel Analytical Methods for Biomarkers
A Early Phase 1 study testing Blood sample collection and an optional cerebrospinal fluid (CSF) collection and Blood sample collection in people with Parkinson Disease, run by Servier at 4 sites in France.
Trial summary
This is a non-drug study in patients with Parkinson's Disease (PD) and healthy volunteers to process and analyze their blood and optional cerebrospinal fluid (CSF) samples ex vivo, or outside of their body, to further develop researchers knowledge on LRRK2 biomarkers. Read more about this study
- Who is it for?
- Ages 30 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Blood sample collection and an optional cerebrospinal fluid (CSF) collection and Blood sample collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 4 sitesFrance
- Study dates
- 11 Jul 2022to 29 Nov 2022
- Phase
- Early Phase 1
- 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 30 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women of childbearing potential (WOCBP) must have a negative pregnancy test
- Parkinson's disease (PD) patients must be at least 40 years old
- Healthy volunteers must be at least 30 years old
- PD patients must have a PD diagnosis, according to the 2015 Movement Disorder Society criteria, with bradykinesia, and at least one of the following: muscular rigidity, or resting tremor with no other suspected cause of Parkinsonism
- The LRRK2 G2019S symptomatic carrier PD patients must have a documented G2019S mutation on the leucine-rich repeat kinase 2 gene (LRRK2)
Who cannot join
- Pregnant or lactating women
- Have participated in an investigational drug trial within 30 days
- Are SARS-CoV-2, COVID-19, positive within 15 days prior to blood sample collection
- Have another active disease that the investigator believes could interfere with study results
Trial locations and contacts
4 sites in 1 country.
France4 sites
Centre Hospitalo-Universitaire Grenoble Alpes
La Tronche, 38700
Centre Hospitalo-Universitaire Lille
Lille, 59000
Hopital La Pitié Salpétrière-Institut du Cerveau et de la Moelle Epinière-CIC Neurosciences
Paris, 75013
Centre Hospitalo-Universitaire Toulouse
Toulouse, 31000
About this study
Official title: An Open-label, Phase 0 Clinical Study in Parkinson's Disease Patients and Healthy Volunteers for the Establishment of Biomarker Analytical Methods and ex Vivo Assessment of the Potency of LRRK2 Inhibitors Using Human Biological Samples.
This is a non-drug study in patients with Parkinson's Disease (PD) and healthy volunteers to process and analyze their blood and optional cerebrospinal fluid (CSF) samples ex vivo, or outside of their body, to further develop researchers knowledge on LRRK2 biomarkers. Participants were enrolled either in Cohort A or in Cohort B. A blood sample was collected in each participant within a maximum of two study visits within 14 days, and an option to complete both visits on the same day.
Read the detailed description
This study will allow researchers to assess the potency of investigational LRRK2 inhibitors, outside of participant bodies. It will enroll Parkinson's disease patients (LRRK2 G2019S symptomatic carriers and idiopathic) and healthy volunteers meeting eligibility criteria. The study will consist of a maximum of two study visits, a selection visit to check eligibility criteria, and a sample collection visit. The two visits can take place on the same day or can occur within 14 days of each other. Participants will be assigned to Cohort A or Cohort B, each include a blood sample collection, and an optional cerebrospinal fluid (CSF) collection in Cohort A. No investigational product, study drug, will be administered to study participants.
- Conditions
- Parkinson Disease
- Being tested
- Blood sample collection and an optional cerebrospinal fluid (CSF) collection, Blood sample collection
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample collection and an optional cerebrospinal fluid (CSF) collectionOther
No study drug will be administered to study participants.
Blood sample collectionOther
No study drug will be administered to study participants.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Experimental | Cohort A will include LRRK2 G2019S symptomatic carriers, idiopathic PD patients, and healthy volunteers. It will involve a blood sample collection and an optional cerebrospinal fluid (CSF) collection. Receives: Other: Blood sample collection and an optional cerebrospinal fluid (CSF) collection |
| Cohort B | Experimental | Cohort B will include LRRK2 G2019S carriers, idiopathic PD patients, and heathy volunteers. It will involve only a blood sample collection. Receives: Other: Blood sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the potency of LRRK2 inhibitors using target engagement biomarker (cohort B)
Measured: Study collection visit Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start11 Jul 2022
- Primary completion29 Nov 2022
- Study completion29 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Servier
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05837130
- Sponsor's protocol ID
- CLE-221237-001
- Acronym
- IRIS-CLE-LRRK2
- Status last verified
- Apr 2025
- First submitted
- 24 Mar 2023
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Access can be requested for all interventional clinical studies: * used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US). * where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope. In addition, access can be requested for all interventional clinical studies in patients: * sponsored by Servier * with a first patient enrolled as of 1 January 2004 onwards * for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Phase 0 Clinical Study in Parkinson's Disease Patients and Healthy Volunteers for the Establishment of Biomarker Analytical Methods and ex Vivo Assessment of the Potency of LRRK2 Inhibitors Using Human Biological Samples.
- ClinicalTrials.gov ID
- NCT05837130
- Acronym / sponsor ID
- IRIS-CLE-LRRK2 / CLE-221237-001
- Conditions
- Parkinson Disease
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- ServierIndustry (pharma, biotech, devices)
- Study start
- 11 Jul 2022 (actual)
- Primary completion
- 29 Nov 2022 (actual)
- Study completion
- 29 Nov 2022 (actual)
- First posted
- 1 May 2023 (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 non-drug study in patients with Parkinson's Disease (PD) and healthy volunteers to process and analyze their blood and optional cerebrospinal fluid (CSF) samples ex vivo, or outside of their body, to further develop researchers knowledge on LRRK2 biomarkers. Participants were enrolled either in Cohort A or in Cohort B. A blood sample was collected in each participant within a maximum of two study visits within 14 days, and an option to complete both visits on the same day.
Detailed description
This study will allow researchers to assess the potency of investigational LRRK2 inhibitors, outside of participant bodies. It will enroll Parkinson's disease patients (LRRK2 G2019S symptomatic carriers and idiopathic) and healthy volunteers meeting eligibility criteria. The study will consist of a maximum of two study visits, a selection visit to check eligibility criteria, and a sample collection visit. The two visits can take place on the same day or can occur within 14 days of each other. Participants will be assigned to Cohort A or Cohort B, each include a blood sample collection, and an optional cerebrospinal fluid (CSF) collection in Cohort A. No investigational product, study drug, will be administered to study participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Experimental | Other: Blood sample collection and an optional cerebrospinal fluid (CSF) collectionCohort A will include LRRK2 G2019S symptomatic carriers, idiopathic PD patients, and healthy volunteers. It will involve a blood sample collection and an optional cerebrospinal fluid (CSF) collection. |
| Cohort B | Experimental | Other: Blood sample collectionCohort B will include LRRK2 G2019S carriers, idiopathic PD patients, and heathy volunteers. It will involve only a blood sample collection. |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women of childbearing potential (WOCBP) must have a negative pregnancy test
- Parkinson's disease (PD) patients must be at least 40 years old
- Healthy volunteers must be at least 30 years old
- PD patients must have a PD diagnosis, according to the 2015 Movement Disorder Society criteria, with bradykinesia, and at least one of the following: muscular rigidity, or resting tremor with no other suspected cause of Parkinsonism
- The LRRK2 G2019S symptomatic carrier PD patients must have a documented G2019S mutation on the leucine-rich repeat kinase 2 gene (LRRK2)
Key exclusion criteria (4 listed)
- Pregnant or lactating women
- Have participated in an investigational drug trial within 30 days
- Are SARS-CoV-2, COVID-19, positive within 15 days prior to blood sample collection
- Have another active disease that the investigator believes could interfere with study results
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 |
|---|---|---|
| Blood sample collection and an optional cerebrospinal fluid (CSF) collectionNo study drug will be administered to study participants. | Other | Cohort A |
| Blood sample collectionNo study drug will be administered to study participants. | Other | Cohort B |
Primary outcome
Assess the potency of LRRK2 inhibitors using target engagement biomarker (cohort B)
Time frame: Study collection visit Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
- Individual participant dataSharing planned: Yes. Access can be requested for all interventional clinical studies: * used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US). * where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope. In addition, access can be requested for all interventional clinical studies in patients: * sponsored by Servier * with a first patient enrolled as of 1 January 2004 onwards * for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Blood sample collection and an optional cerebrospinal fluid (CSF) collection and Blood sample collection in people with Parkinson Disease, run by Servier at 4 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 5 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: finished, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assess the potency of LRRK2 inhibitors using target engagement biomarker (cohort B) (time frame: Study collection visit Day 1). 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 11 Apr 2025; AzTrials last refreshed its copy on 8 Nov 2026.