Systematic Follow up of Second Line Treatments for Parkin... | NCT05072015

Studies
Systematic Follow up of Second Line Treatments for Parkinson's Disease (Deep Brain Stimulation, Apomorphin Pump, Duodopa Pump)

NCT05072015

Sponsor

University Hospital, Strasbourg, France

Status

Not yet recruiting

Last Update Posted

Feb 17, 2022Actual

Enrollment

150Estimated

Phase

Not provided

Conditions

Parkinson's Disease

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

Jan 2022

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2022Estimated

Primary Completion Date

Feb 2022Estimated

Completion Date

Mar 2028Estimated

First Submitted Date

Sep 30, 2021

First Submission Date that Met QC Criteria

Sep 30, 2021

First Posted Date

Oct 8, 2021Actual

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

Feb 1, 2022

Last Update Posted Date

Feb 17, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

Primary purpose: Fluctuations and dyskinesia evolution in Parkinson's disease patients, one year after initiation of deep brain stimulation, apomorphin pump or duodopa pump

Secundary purposes:

Motor complications evolution at 6 months, 2 and 3 years
MDS UPDRS III score at 6 months, 1, 2 and 3 years
non motor complications evolution at 6 months, 1, 2 and 3 years
cognition and psychiatric complications evolution at 6 months, 1, 2 and 3 years
cutaneous and digestive complications at 6 months, 1, 2 and 3 years
neuropathy occurrence at 6 months, 1, 2 and 3 years
medical treatment and Levodopa equivalent dose modifications at 6 months, 1, 2 and 3 years

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

150Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
MDS UPDRS IV (Movement Disorder Society - Unified Parkin-son Disease Rating Scale) score improvement	Evaluate the evolution of motor fluctuations and dyskinesias at one year in patients. treated with one of the 3 TSLs (bilateral stimulation of the subthalamic nucleus, apomorphine pump and duodopa pump. the higher the score, the more the disease is installed	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Parkinson disease (UKPDSSB criteria)
Patient with fluctuations and/or dyskinesia , who need treatment with deep brain stimulation, apomorphin pump or duodopa pump
MOCA >20
patient >21 years of age
patient who has signed protocol acceptation

Exclusion criteria:

patient who did not give his acceptation for the protocol
patient with another parkinsonian syndrome than Parkinson' s disease
MOCA<20
Patient who does not need second line treatment

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with advanced Parkinson' s disease who need second line treatment

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mathieu ANHEIM	Contact	+33 3 88 12 85 35		mathieu.anheim@chru-strasbourg.fr

Overall Officials

Name	Affiliation	Role
Mathieu ANHEIM	Les Hôpitaux Universitaires de Strasbourg	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mathieu ANHEIM		Strasbourg		67098	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010300	Parkinson Disease

Ancestor Terms

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided