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

Primary Purpose

Parkinson's Disease

Status
Terminated
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Apomorphine
Sponsored by
Fondation Ophtalmologique Adolphe de Rothschild
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fondation ophtalmique Adolphe de Rothschild

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Apomorphine pump

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 18, 2016
Last Updated
March 22, 2018
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
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1. Study Identification

Unique Protocol Identification Number
NCT02688465
Brief Title
Effect of an Apomorphine Pump on the Quality of Sleep in Parkinson's Disease Patients (POMPRENELLE).
Acronym
POMPRENELLE
Official Title
Effect of an Apomorphine Pump on the Quality of Sleep in Parkinson's Disease Patients (POMPRENELLE).
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Terminated
Study Start Date
September 5, 2016 (Actual)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Ophtalmologique Adolphe de Rothschild

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Apomorphine pump
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Apomorphine
Primary Outcome Measure Information:
Title
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
Time Frame
Three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Fondation ophtalmique Adolphe de Rothschild
City
Paris
ZIP/Postal Code
75019
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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