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

NCT02688465 — Phase 4, Terminated, 15 participants, Fondation Ophtalmologique Adolphe de Rothschild

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RegistryNCT02688465, acronym POMPRENELLE
StatusTerminated
PhasePhase 4
Study typeInterventional; na, single group, masking: none, treatment
Enrollment15 (Actual)
SponsorFondation Ophtalmologique Adolphe de Rothschild (Network)
ConditionsParkinson's Disease
InterventionsApomorphine (Drug)
Datesstart 2016-09-05, primary completion 2017-01-01, completion 2017-07-01, first posted 2016-02-23, last updated 2018-03-26
Locations1 site in France

Related Papers Related Patents Related Grants Related Experts
All trials for Parkinson's Disease All trials of Apomorphine

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Apomorphine pumpExperimentalDrug: Apomorphine
  • Apomorphine (Drug)

+Outcome measures

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 [Three months]

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

FacilityCityCountryStatus
Fondation ophtalmique Adolphe de RothschildParisFrance