Status:

RECRUITING

Personality and Quality of Life Amelioration After Continuous Subcutaneous Apomorphine Infusion in Parkinson's Disease

Lead Sponsor:

University Hospital, Toulouse

Collaborating Sponsors:

ELIVIE France

EVER Pharma France SAS

Conditions:

Parkinson Disease

Eligibility:

All Genders

18+ years

Brief Summary

Since our previous study has shown that some personality dimensions were associated with Quality of Life (QoL) amelioration after Deep Brain Stimulation (DBS) in Parkinson's disease (PD), the investig...

Detailed Description

As Parkinson's disease (PD) progresses, the onset of motor and non-motor fluctuations alters patients Quality of Life (QoL). Second-line treatments can then be proposed: either the implantation of dee...

Eligibility Criteria

Inclusion

  • Parkinson's disease patients as defined by the United Kingdom Parkinson's disease Brain Bank (UKPDSBB) criteria and aged from 40 to 75 years old (included)
  • Patients with motor fluctuations and/or invalidating dyskinesia and awaiting CSAI establishment in the context of their usual care for PD
  • Patients affiliated to a social security system

Exclusion

  • Patients presenting an atypical parkinsonian syndrome Patients having a Deep Brain Stimulation
  • Patients with a psychiatric disease such as bipolar disorder or delusions linked to a dopaminergic psychosis
  • Patients presenting a cognitive deficit attested by a score to the Montreal Cognitive Assessment inferior to 24, solely during the inclusion (baseline - V0)
  • Patient with a serious pathology (e.g. cancer) or a health condition which could interfere with the assessment of their quality of life, at the discretion of the investigator upon inclusion
  • Patients under guardianship, curatorship or safeguard of justice
  • Patients under exclusion period from another study

Key Trial Info

Start Date :

February 15 2024

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

April 1 2026

Estimated Enrollment :

70 Patients enrolled

Trial Details

Trial ID

NCT06080399

Start Date

February 15 2024

End Date

April 1 2026

Last Update

August 29 2024

Active Locations (10)

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Page 1 of 3 (10 locations)

1

Chu de Lyon

Bron, France

2

Hopital Gabriel Montpied

Clermont-Ferrand, France

3

Chu de Grenoble

Grenoble, France

4

Chu Limoges

Limoges, France