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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02688465
Other study ID # CHH_2016_01
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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