Prognosis of Behavioral Addiction in Parkinson's Disease (PROBA-PD)

August 21, 2023 updated by: University Hospital, Strasbourg, France

Our hypothesis is that the conventional treatment of Behavioral Addiction in Parkinson's disease is often not effective, and that affects the motor aspects (worsening akinéto-rigid syndrome and / or worsening of dyskinesia due to higher levodopa doses to compensate for the drop in behavioral addictions) and non-motor (withdrawal syndrome dopamine agonist) anxiously including apathy.

Our goal is to describe the natural history of Behavioral Addiction under the effect of the evolution of the disease and adapt treatment according to the prior art, through a study of a larger population of patients than in the few published studies.

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

164

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Strasbourg, France, 67098
        • Service de neurologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with Parkinson's disease who developed or not a behavioral addiction

Description

Inclusion criteria:

  • Age greater than or equal to 30 years
  • Parkinson's disease according to the criteria of UKPDSBB
  • Time evolution of the top disease or equal to 5 years

Exclusion criteria:

  • Lack of Parkinson's disease and atypical parkinsonism
  • Patient not previously included in PD-BADGE

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
- Patients with behavioral addiction
- Patients with no behavioral addiction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Survival time before disappearance of behavioral addiction defined by a score of less than 2 on the scale of behavioral assessment of Parkinson's disease
Time Frame: 12 months after selection
12 months after selection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Investigators

  • Study Director: Mathieu ANHEIM, MD, PhD, University Hospital, Strasbourg, france

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 24, 2016

Primary Completion (Actual)

April 19, 2019

Study Completion (Actual)

April 19, 2019

Study Registration Dates

First Submitted

January 18, 2016

First Submitted That Met QC Criteria

January 28, 2016

First Posted (Estimated)

February 2, 2016

Study Record Updates

Last Update Posted (Actual)

August 23, 2023

Last Update Submitted That Met QC Criteria

August 21, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6246 (CTEP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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