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

Parkinson's Disease Clinical Trial

— POMPRENELLE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02688465
• Other study ID #: CHH_2016_01
• Status: Terminated
• Phase: Phase 4
• First received: February 18, 2016
• Last updated: March 22, 2018
• Start date: September 5, 2016
• Est. completion date: July 2017

Study information

• Verified date: March 2018
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: July 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• Apomorphine

Locations

Country	Name	City	State
France	Fondation ophtalmique Adolphe de Rothschild	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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