Back to resultsNon-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)
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Early Phase 1
Locations
France
Study Type
Interventional
Intervention
Blood sample collection and an optional cerebrospinal fluid (CSF) collection
Blood sample collection
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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
Sites / Locations
- Centre Hospitalo-Universitaire Grenoble Alpes
- Centre Hospitalo-Universitaire Lille
- Hopital La Pitié Salpétrière-Institut du Cerveau et de la Moelle Epinière-CIC Neurosciences
- Centre Hospitalo-Universitaire Toulouse
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Cohort A
Cohort B
Arm Description
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.
Cohort B will include LRRK2 G2019S carriers, idiopathic PD patients, and heathy volunteers. It will involve only a blood sample collection.
Outcomes
Primary Outcome Measures
Assess the potency of LRRK2 inhibitors using target engagement biomarker (cohort B)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05837130
Brief Title
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
Acronym
IRIS-CLE-LRRK2
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.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
July 11, 2022 (Actual)
Primary Completion Date
November 29, 2022 (Actual)
Study Completion Date
November 29, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Servier
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Analysis is done ex-vivo and arm assignment is based on if the participant is symptomatic or not.
Allocation
Non-Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort A
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort B
Arm Type
Experimental
Arm Description
Cohort B will include LRRK2 G2019S carriers, idiopathic PD patients, and heathy volunteers. It will involve only a blood sample collection.
Intervention Type
Other
Intervention Name(s)
Blood sample collection and an optional cerebrospinal fluid (CSF) collection
Intervention Description
No study drug will be administered to study participants.
Intervention Type
Other
Intervention Name(s)
Blood sample collection
Intervention Description
No study drug will be administered to study participants.
Primary Outcome Measure Information:
Title
Assess the potency of LRRK2 inhibitors using target engagement biomarker (cohort B)
Time Frame
Study collection visit Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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
Facility Information:
Facility Name
Centre Hospitalo-Universitaire Grenoble Alpes
City
La Tronche
ZIP/Postal Code
38700
Country
France
Facility Name
Centre Hospitalo-Universitaire Lille
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
Hopital La Pitié Salpétrière-Institut du Cerveau et de la Moelle Epinière-CIC Neurosciences
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Centre Hospitalo-Universitaire Toulouse
City
Toulouse
ZIP/Postal Code
31000
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
After Marketing Authorization in EEA or US if the study is used for the approval.
IPD Sharing 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.
IPD Sharing URL
http://clinicaltrials.servier.com/
Learn more about this trial
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
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