NCT02671240

Brief Summary

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
164

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 2, 2016

Completed
9 months until next milestone

Study Start

First participant enrolled

October 24, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 19, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 19, 2019

Completed
Last Updated

August 23, 2023

Status Verified

August 1, 2023

Enrollment Period

2.5 years

First QC Date

January 18, 2016

Last Update Submit

August 21, 2023

Conditions

Keywords

Parkinson diseasebehavioral addictionakinéto-rigid syndromedopamine agonist

Outcome Measures

Primary Outcomes (1)

  • 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

    12 months after selection

Study Arms (2)

- Patients with behavioral addiction

- Patients with no behavioral addiction

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Neurologie

Strasbourg, 67098, France

Location

MeSH Terms

Conditions

Behavior, AddictiveParkinson Disease

Condition Hierarchy (Ancestors)

Compulsive BehaviorImpulsive BehaviorBehaviorParkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Mathieu ANHEIM, MD, PhD

    University Hospital, Strasbourg, France

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2016

First Posted

February 2, 2016

Study Start

October 24, 2016

Primary Completion

April 19, 2019

Study Completion

April 19, 2019

Last Updated

August 23, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations