Effect of an Apomorphine Pump on the Quality of Sleep in... | NCT02688465

Studies
Effect of an Apomorphine Pump on the Quality of Sleep in Parkinson's Disease Patients (POMPRENELLE).

NCT02688465

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Status

Terminated

Last Update Posted

Mar 26, 2018Actual

Enrollment

15Actual

Phase

Phase 4

Conditions

Parkinson's Disease

Interventions

Apomorphine

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

Mar 2018

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 5, 2016Actual

Primary Completion Date

Jan 2017Actual

Completion Date

Jul 2017Actual

First Submitted Date

Feb 18, 2016

First Submission Date that Met QC Criteria

Feb 18, 2016

First Posted Date

Feb 23, 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

Mar 22, 2018

Last Update Posted Date

Mar 26, 2018Actual

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

Parkinson's disease is not only a pathology of movements. There are many non-motor symptoms that complicate and impair patients' quality of life. Among those disorders are sleep disorders.

Insomnia is the most frequent symptom. Most patients report 2-5 awakenings per night and long periods of awakening which occupy 30 to 40% of their night.

Apomorphine is a dopamine agonist that may be administered with a pump . The objective of the study is to assess changes in the quality of sleep in Parkinson's disease patients treated with an apomorphine pump.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Label	Type	Description	Intervention Names
Apomorphine pump	Experimental		Drug: Apomorphine

Name	Type	Description	Arm Group Labels	Other Names
Apomorphine	Drug		Apomorphine pump

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Difference between the Parkinson's disease sleeping disorders (PDSD-2) score before treatment with an apomorphine pump and 3 months after the beginning of the treatment		Three months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Parkinson's disease patients for whom a treatment with an apomorphine pump is indicated

Exclusion Criteria:

atypical parkinsonian syndrome
cognitive impairment
pregnancy
breast feeding
patient under a legal protection procedure
patient denying to participate to the study
lack of affiliation to a social security system

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fondation ophtalmique Adolphe de Rothschild		Paris		75019	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
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

Intervention Browse Module

MeSH Terms

ID	Term
D001058	Apomorphine

Ancestor Terms

ID	Term
D001060	Aporphines
D044182	Benzylisoquinolines
D000470	Alkaloids
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided