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Clinical Trials/NCT02688465
NCT02688465
Terminated
Phase 4

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

Fondation Ophtalmologique Adolphe de Rothschild1 site in 1 country15 target enrollmentSeptember 5, 2016
InterventionsApomorphine

Overview

Phase
Phase 4
Intervention
Apomorphine
Conditions
Parkinson's Disease
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
Enrollment
15
Locations
1
Primary Endpoint
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
Status
Terminated
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 5, 2016
End Date
July 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

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

Arms & Interventions

Apomorphine pump

Intervention: Apomorphine

Outcomes

Primary Outcomes

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

Study Sites (1)

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