Prognosis of Behavioral Addiction in Parkinson's Disease | NCT02671240

Studies
Prognosis of Behavioral Addiction in Parkinson's Disease

NCT02671240

Sponsor

University Hospital, Strasbourg, France

Status

Terminated

Last Update Posted

Aug 23, 2023Actual

Enrollment

164Actual

Phase

Not provided

Conditions

Addiction

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Investigator's decision

Expanded Access Info

Start Date

Oct 24, 2016Actual

Primary Completion Date

Apr 19, 2019Actual

Completion Date

Apr 19, 2019Actual

First Submitted Date

Jan 18, 2016

First Submission Date that Met QC Criteria

Jan 28, 2016

First Posted Date

Feb 2, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 21, 2023

Last Update Posted Date

Aug 23, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

164Actual

Outcomes Module

Primary Outcomes

Measure	Description	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		12 months after selection

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mathieu ANHEIM, MD, PhD	University Hospital, Strasbourg, France	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service de Neurologie		Strasbourg		67098	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016739	Behavior, Addictive
D010300	Parkinson Disease

Ancestor Terms

ID	Term
D003192	Compulsive Behavior
D007175	Impulsive Behavior
D001519	Behavior
D020734	Parkinsonian Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Label	Type	Description	Intervention Names
- Patients with behavioral addiction
- Patients with no behavioral addiction