Parkinson DiseaseNS-PARKNCT04888364
French Parkinson's Disease Cohort - NS-PARK
An observational study of Parkinson Disease, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
The aim of NS-PARK cohort are to describe the natural history of Parkinson's disease (PD), and to propose patients stratification models based on PD pathophysiological mechanisms. Patients are included at all PD expert centers in France. Read more about this study
- Who is it for?
- Ages 10 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- How many people
- 30,000 participants
- Where
- 1 siteFrance
- Study dates
- 16 Jun 2021to 31 Dec 2034
- How long will I take part?
- 15 Years
- Phase
- Observational
- 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 10 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All patients followed at one expert center for PD or associated centers in France.
Who may be able to join
- Diagnosis of Parkinson's disease according to UK PD brain bak criteria
- OR diagnosis of parkinsonian syndrome: multiple system atrophy, progressive supranuclear palsy, dementia with Lewy body, or corticobasal syndrom
- OR Subjects at risk of PD defined as :
- No symptom or diagnosis of Parkinson's disease nor parkinsonian syndrome, and relative to a patient with a diagosis of PD or parkinsonian syndrome, or carrier of a known mutation responsible for a genetic form of PD or patient with a diagnosis of idiopathic REEM sleep disorder or prodromal form of PD as defined by MDS criteria (Berg et al., 2015)
- AND for all participants
- Affiliated to social security
- Age > 10 years
Who cannot join
- Subject under legal protection
- Subject who do not consent to the research
- for the optional skin biopsy only: clinically significant coagulation abnormalities or anticoagulant treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre 01 Paris
Paris, 75013
Jean Christophe MD Corvol, Pr, 33 1 42 16 57 66, jean-christophe.corvol@aphp.fr
Jean Christophe MD Corvol, Pr
About this study
Official title: Cohort of the French Clinical Research Network for Parkinson's Disease (NS-PARK Cohort)
The aim of NS-PARK cohort are to describe the natural history of Parkinson's disease (PD), and to propose patients stratification models based on PD pathophysiological mechanisms. Patients are included at all PD expert centers in France. Standardized demographic, diagnosis, motor and non-motor symptoms evaluation, and treatment information are collected, and clinical data are updated at each visit of the patient at the center. A blood sampling is perform at baseline for genetic testing and implement an associated biocollection.
Read the detailed description
The national clinical research network for Parkinson's disease (NS-PARK/FCRIN) reassembles all expert centers in Parkinson's disease (PD) in France. Its aim is to promote clinical research in Parkinson's disease and movement disorder, to better understand the pathophysiology of PD, foster the development of new therapeutic strategies, and move towards personalized medicine. To help centers for prescreening, a national registry of PD patients followed in each centers has been implemented in 2016 to collect minimal relevant clinical information of patients followed in each center including demographic data, age at diagnosis, standardized motor and non-motor symptoms evaluation, and treatment. Data are updated at each visit of the patient in the center. De facto, this registry became a longitudinal cohort of PD patients followed in NS-PARK centers. In 2020, NS-PARK received funding to associate a biocollection to this clinical cohort.
The aim of NS-PARK cohort are to describe the natural history of PD progression in clinical routine in France, to develop new models of PD describing the different progression profiles, and to propose patients stratification based on PD pathophysiological mechanisms. The cohort will also serve as a platform to discover new PD genes and genetic modifiers of disease progression or response to treatment.
- Conditions
- Parkinson Disease
- Keywords
- Parkinson's disease, Genetics
- Medical subject headings
- Parkinson Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease progression
Hoehn and Yahr score change
Measured: through the end of follow-up in the cohort, at least 2 years, and average of 5 years
Motor and non-motor complications
Occurence of motor (dyskinesia or motor fluctuations) or non-motor (dementia, dysautonomia, behavioral or psychiatric disorders, sleep disorders, falls, ...) complication
Measured: through the end of follow-up in the cohort, at least 2 years, and average of 5 years
Modification of antiparkinsonian treatment doses
Modification of antiparkinsonian treatment during follow-up will be measured as levodopa equivalent daily doses
Measured: through the end of follow-up in the cohort, at least 2 years, and average of 5 years
Secondary outcomes (6)
Predictive factorsof PD progression: motor or non motor symptoms
Motor or non motor symptoms as measured by MDS-UPDRS scores will be used as predictive factors for primary outcomes
Measured: through the end of follow-up in the cohort, at least 2 years, and average of 5 years
Predictive factors of PD progression: genetic variants
Genetic variants in PD genes or the Genetic PD risk score will be used as predictive factors for primary outcomes.
Measured: through the end of follow-up in the cohort, at least 2 years, and average of 5 years
Predictive factors of PD progression: brain imaging markers
Brain imaging makers (iron or neuromelanine content of the substantia nigra) will be used as predictive factors for primary outcomes
Measured: through the end of follow-up in the cohort, at least 2 years, and average of 5 years
Clusters of patients with similar disease progression profiles
Clustering analyses will be performed on disease progression markers (Hoehn and Yahr score, MDS-UPDRS scores, and doses of treatment (levodopa equivalent daily doses)) to identify homogeneous groups of patients (clusters) sharing similar disease progression profiles.
Measured: through the end of follow-up in the cohort, at least 2 years, and average of 5 years
Clusters of patients with similar genetic and disease progression profiles
Co-clustering analysis of disease progression markers (Hoehn and Yahr score, MDS-UPDRS scores, and doses of treatment (levodopa equivalent daily doses)) and genetic markers (variants in PD genes or the Genetic PD risk score).
Measured: through the end of follow-up in the cohort, at least 2 years, and average of 5 years
Genetic mutations associated with familal forms of PD
Genetic mutations will be screened by different methods (gene panels, whole exome or whole genome) in familial forms of PD. Mutations co-segregated with PD will be considered as potentially associated with the disease.
Measured: through study completion, 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start16 Jun 2021
- Primary completion31 Dec 2032 (estimated)
- Study completion31 Dec 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe 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
- 30,000 participants (estimated)
- Target duration
- 15 Years
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Jean Christophe MD CORVOL, PU-PH, Principal investigator, UMRS 1127
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04888364
- Sponsor's protocol ID
- C16-56
- Other IDs
- 2019-A01929-48
- Acronym
- NS-PARK
- Status last verified
- Aug 2026
- First submitted
- 19 Apr 2021
- Last updated
- 20 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lanore A, Januel E, Bertille N, Fabbri M, Mariani LL, Mangone G, Sambin S, Menon PJ, Tir M, Bereau M, Meissner WG, Thiriez C, Marques A, Remy P, Dupont G, Moro E, Defebvre L, Houeto JL, Thobois S, Azulay JP, Geny C, Frismand S, Damier P, Giordana C, Castelnovo G, Ansquer S, De Maindreville AD, Drapier S, Maltete D, Tranchant C, Rascol O, Tubach F, De Rycke Y, Corvol JC; French NS-Park Network. Motor and Non-motor Complications Following Different Early Therapies in Parkinson's Disease: Longitudinal Analysis of Real-Life Clinical and Therapeutic Data from the French NS-PARK Cohort. CNS Drugs. 2025 Sep;39(9):879-891. doi: 10.1007/s40263-025-01193-5. Epub 2025 May 25.
PubMed 40415148
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort of the French Clinical Research Network for Parkinson's Disease (NS-PARK Cohort)
- ClinicalTrials.gov ID
- NCT04888364
- Acronym / sponsor ID
- NS-PARK / C16-56
- Conditions
- Parkinson Disease
- Keywords
- Parkinson's disease, Genetics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30,000 participants (estimated)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 16 Jun 2021 (actual)
- Primary completion
- 31 Dec 2032 (estimated)
- Study completion
- 31 Dec 2034 (estimated)
- First posted
- 17 May 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 NS-PARK cohort are to describe the natural history of Parkinson's disease (PD), and to propose patients stratification models based on PD pathophysiological mechanisms. Patients are included at all PD expert centers in France. Standardized demographic, diagnosis, motor and non-motor symptoms evaluation, and treatment information are collected, and clinical data are updated at each visit of the patient at the center. A blood sampling is perform at baseline for genetic testing and implement an associated biocollection.
Detailed description
The national clinical research network for Parkinson's disease (NS-PARK/FCRIN) reassembles all expert centers in Parkinson's disease (PD) in France. Its aim is to promote clinical research in Parkinson's disease and movement disorder, to better understand the pathophysiology of PD, foster the development of new therapeutic strategies, and move towards personalized medicine. To help centers for prescreening, a national registry of PD patients followed in each centers has been implemented in 2016 to collect minimal relevant clinical information of patients followed in each center including demographic data, age at diagnosis, standardized motor and non-motor symptoms evaluation, and treatment. Data are updated at each visit of the patient in the center. De facto, this registry became a longitudinal cohort of PD patients followed in NS-PARK centers. In 2020, NS-PARK received funding to associate a biocollection to this clinical cohort.
The aim of NS-PARK cohort are to describe the natural history of PD progression in clinical routine in France, to develop new models of PD describing the different progression profiles, and to propose patients stratification based on PD pathophysiological mechanisms. The cohort will also serve as a platform to discover new PD genes and genetic modifiers of disease progression or response to treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 15 Years
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients followed at one expert center for PD or associated centers in France.
Key inclusion criteria (7 listed)
- Diagnosis of Parkinson's disease according to UK PD brain bak criteria
- OR diagnosis of parkinsonian syndrome: multiple system atrophy, progressive supranuclear palsy, dementia with Lewy body, or corticobasal syndrom
- OR Subjects at risk of PD defined as :
- No symptom or diagnosis of Parkinson's disease nor parkinsonian syndrome, and relative to a patient with a diagosis of PD or parkinsonian syndrome, or carrier of a known mutation responsible for a genetic form of PD or patient with a diagnosis of idiopathic REEM sleep disorder or prodromal form of PD as defined by MDS criteria (Berg et al., 2015)
- AND for all participants
Key exclusion criteria (3 listed)
- Subject under legal protection
- Subject who do not consent to the research
- for the optional skin biopsy only: clinically significant coagulation abnormalities or anticoagulant treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Disease progression
Time frame: through the end of follow-up in the cohort, at least 2 years, and average of 5 years
Hoehn and Yahr score change
Motor and non-motor complications
Time frame: through the end of follow-up in the cohort, at least 2 years, and average of 5 years
Occurence of motor (dyskinesia or motor fluctuations) or non-motor (dementia, dysautonomia, behavioral or psychiatric disorders, sleep disorders, falls, ...) complication
Modification of antiparkinsonian treatment doses
Time frame: through the end of follow-up in the cohort, at least 2 years, and average of 5 years
Modification of antiparkinsonian treatment during follow-up will be measured as levodopa equivalent daily doses
6 secondary outcomes
Predictive factorsof PD progression: motor or non motor symptoms
Time frame: through the end of follow-up in the cohort, at least 2 years, and average of 5 years
Predictive factors of PD progression: genetic variants
Time frame: through the end of follow-up in the cohort, at least 2 years, and average of 5 years
Predictive factors of PD progression: brain imaging markers
Time frame: through the end of follow-up in the cohort, at least 2 years, and average of 5 years
Clusters of patients with similar disease progression profiles
Time frame: through the end of follow-up in the cohort, at least 2 years, and average of 5 years
Clusters of patients with similar genetic and disease progression profiles
Time frame: through the end of follow-up in the cohort, at least 2 years, and average of 5 years
Genetic mutations associated with familal forms of PD
Time frame: through study completion, 15 years
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 20 Aug 2026.
- Derived from this study: PubMed 40415148Lanore A, Januel E, Bertille N, Fabbri M, Mariani LL, Mangone G, Sambin S, Menon PJ, Tir M, Bereau M, Meissner WG, Thiriez C, Marques A, Remy P, Dupont G, Moro E, Defebvre L, Houeto JL, Thobois S, Azulay JP, Geny C, Frismand S, Damier P, Giordana C, Castelnovo G, Ansquer S, De Maindreville AD, Drapier S, Maltete D, Tranchant C, Rascol O, Tubach F, De Rycke Y, Corvol JC; French NS-Park Network. Motor and Non-motor Complications Following Different Early Therapies in Parkinson's Disease: Longitudinal Analysis of Real-Life Clinical and Therapeutic Data from the French NS-PARK Cohort. CNS Drugs. 2025 Sep;39(9):879-891. doi: 10.1007/s40263-025-01193-5. Epub 2025 May 25.
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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.
Jean Christophe MD CORVOL, PU-PH principal investigator
UMRS 1127
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Institut National de la Santé Et de la Recherche Médicale, France 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 7 inclusion and 3 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 20 Aug 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 Jean Christophe MD CORVOL, PU-PH (33 1 42 16 57 66, jean-christophe.corvol@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease progression (time frame: through the end of follow-up in the cohort, at least 2 years, and average of 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04888364, which also lists 1 linked publication.
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 20 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.