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
IRIS-CLE-LRRK2
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.
1 other identifier
interventional
45
1 country
4
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1 parkinson-disease
Started Jul 2022
Shorter than P25 for early_phase_1 parkinson-disease
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 11, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 29, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 29, 2022
CompletedFirst Submitted
Initial submission to the registry
March 24, 2023
CompletedFirst Posted
Study publicly available on registry
May 1, 2023
CompletedApril 11, 2025
April 1, 2025
5 months
March 24, 2023
April 8, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Assess the potency of LRRK2 inhibitors using target engagement biomarker (cohort B)
Study collection visit Day 1
Study Arms (2)
Cohort A
EXPERIMENTALCohort 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
EXPERIMENTALCohort B will include LRRK2 G2019S carriers, idiopathic PD patients, and heathy volunteers. It will involve only a blood sample collection.
Interventions
No study drug will be administered to study participants.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Servierlead
Study Sites (4)
Centre Hospitalo-Universitaire Grenoble Alpes
La Tronche, 38700, France
Centre Hospitalo-Universitaire Lille
Lille, 59000, France
Hopital La Pitié Salpétrière-Institut du Cerveau et de la Moelle Epinière-CIC Neurosciences
Paris, 75013, France
Centre Hospitalo-Universitaire Toulouse
Toulouse, 31000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Masking Details
- Analysis is done ex-vivo and arm assignment is based on if the participant is symptomatic or not.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2023
First Posted
May 1, 2023
Study Start
July 11, 2022
Primary Completion
November 29, 2022
Study Completion
November 29, 2022
Last Updated
April 11, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- After Marketing Authorization in EEA or US if the study is used for the approval.
- Access Criteria
- Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.
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.