Evolution of Hypodopaminergic Syndrome in Early Parkinson's Disease

NCT ID: NCT03141944

Last Updated: 2021-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-02-23

Study Completion Date

2020-03-11

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The objective of this study is to describe the evolution of hypodopaminergic syndrome in patients with Parkinson's disease.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

All patients to be included have been clinically described in the early phase of their disease, before instauration of dopaminergic treatment, in the context of a former study ("Non Motor Aspects in De Novo Parkinson's Disease (Honeymoon) NCT02786667") between june 2012 and june 2016.

3 to 5 years after this study, those patients who started dopaminergic treatment will be evaluated again.

The objective of this study, which takes place 3 to 5 year after the initial evaluation, is to measure the evolution of apathy and other symptoms of the hypodopaminergic syndrome.

Secondary objectives are the evolution of other parameters including pain, personality and behavior. All parameters measured have been determined of each patient in the Honeymoon study.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Parkinson Disease Apathy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Apathetic patients

De novo Parkinson's Disease patients with Apathy which participated in a former study and are under dopaminergic treatment at inclusion.

All patients will be evaluated with regard to apathy, depression, pain, behavior and personality. Primary outcome measure is the degree of Apathy by the "Starkstein scale of apathy"

Starkstein scale of Apathy

Intervention Type OTHER

The degree of apathy will be evaluated with the "Starkstein scale of Apathy"

Non-apathetic patients

De novo Parkinson's Disease patients without Apathy which participated in a former study and are under dopaminergic treatment at inclusion.

All patients will be evaluated with regard to apathy, depression, pain, behavior and personality. Primary outcome measure is the degree of Apathy by the "Starkstein scale of apathy"

Starkstein scale of Apathy

Intervention Type OTHER

The degree of apathy will be evaluated with the "Starkstein scale of Apathy"

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Starkstein scale of Apathy

The degree of apathy will be evaluated with the "Starkstein scale of Apathy"

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* patients who participated in "Non Motors Aspects in De Novo Parkinson's Disease (Honeymoon)" NCT02786667
* Patients under dopaminergic treatment, with stable dopaminergic treatment for at least 2 months
* Patients with medical insurance
* signed informed consent

Exclusion Criteria

* diagnosis other than Parkinson's Disease
* dementia (Mattis \<130)
* patients protected by law (i.e. pregnant or parturient women)
Minimum Eligible Age

33 Years

Maximum Eligible Age

72 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Anna CASTRIOTO, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital of Grenoble

Grenoble, , France

Site Status

Hôpital Neurologique Pierre Wertheimer

Lyon, , France

Site Status

Centre Expert Régional pour la maladie de Parkinson

Poitiers, , France

Site Status

Hôpital de Hautepierre

Strasbourg, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

38RC16.184

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Psychiatry Study: Parkinson Disease
NCT02893449 COMPLETED NA