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

• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02688465
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arm: 1
• Actual Duration (Months): 9.8
• Patients Per Site Per Month: 1.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson's Disease	Drug: Apomorphine	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effect of an Apomorphine Pump on the Quality of Sleep in Parkinson's Disease Patients (POMPRENELLE).
• Actual Study Start Date: Sep 5, 2016
• Actual Primary Completion Date: Jan 1, 2017
• Actual Study Completion Date: Jul 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Apomorphine pump	Drug: Apomorphine

Outcome Measures

Primary Outcome Measures

1. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fondation ophtalmique Adolphe de Rothschild	Paris		France	75019

Sponsors and Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
• ClinicalTrials.gov Identifier: NCT02688465
• Other Study ID Numbers: CHH_2016_01
• First Posted: Feb 23, 2016
• Last Update Posted: Mar 26, 2018
• Last Verified: Mar 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Parkinson Disease; Apomorphine

Study Results

No Results Posted as of Mar 26, 2018