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

This study is currently recruiting participants.
Verified May 2017 by University Hospital, Strasbourg, France
Sponsor:
ClinicalTrials.gov Identifier:
NCT02671240
First Posted: February 2, 2016
Last Update Posted: May 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
  Purpose

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.


Condition
Addiction

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective

Resource links provided by NLM:


Further study details as provided by University Hospital, Strasbourg, France:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 200
Actual Study Start Date: October 24, 2016
Estimated Study Completion Date: October 24, 2021
Estimated Primary Completion Date: October 24, 2021 (Final data collection date for primary outcome measure)
Groups/Cohorts
- Patients with behavioral addiction
- Patients with no behavioral addiction

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Parkinson's disease who developed or not a behavioral addiction
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02671240


Contacts
Contact: Mathieu ANHEIM, MD, PhD 33 (0)3 88 12 85 32 mathieu.anheim@chru-strasbourg.fr

Locations
France
Service de Neurologie Recruiting
Strasbourg, France, 67098
Contact: Mathieu ANHEIM, MD, PhD    03 88 12 85 32    mathieu.anheim@chru-strasbourg.fr   
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Study Director: Mathieu ANHEIM, MD, PhD University Hospital, Strasbourg, France
  More Information

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT02671240     History of Changes
Other Study ID Numbers: 6246
First Submitted: January 18, 2016
First Posted: February 2, 2016
Last Update Posted: May 22, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University Hospital, Strasbourg, France:
Parkinson disease
behavioral addiction
akinéto-rigid syndrome
dopamine agonist

Additional relevant MeSH terms:
Parkinson Disease
Behavior, Addictive
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Compulsive Behavior
Impulsive Behavior