NCT01039090

Brief Summary

In Parkinson's disease, treatment mainly aims to improve motor functions. However, other dysfunctions are often observed in Parkinson's patients, and may have important consequences on the quality of life of patients. Cognitive and neuropsychological troubles may be observed, as memory impairment or anxiety for example. As this kind of troubles is worrying for the patient himself (herself) and his/her family, treatment needs to take into account those troubles in addition to motor difficulties. In our centre, we have already used continuous Apomorphine infusions among Parkinson's patients and it seems to have good results. The present study aims to objectively assess the efficacy of continuous Apomorphine infusions on cognitive and neuropsychological functions in Parkinson's disease using clinical and positron emission tomography (PET)-scan measures.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2009

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 24, 2009

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

May 24, 2023

Status Verified

May 1, 2023

Enrollment Period

5 years

First QC Date

December 22, 2009

Last Update Submit

May 22, 2023

Conditions

Parkinsons's Disease

Keywords

Not eligible for deep brain stimulationParkinsons's patients

Outcome Measures

Primary Outcomes (1)

  • Neuropsychological results: Montgomery-Åsberg Depression Rating Scale (MADRS), The Lille Apathy Rating Scale (LARS), Spielberger

    6 months

Study Arms (2)

Per os dopaminergic treatment

ACTIVE COMPARATOR
Drug: Usual dopaminergic per os treatment

Continuous Apomorphine infusion

EXPERIMENTAL
Drug: Continuous Apomorphine infusion

Interventions

Continuous Apomorphine infusionDRUG

Continuous Apomorphine infusion during 6 months

Continuous Apomorphine infusion
Usual dopaminergic per os treatmentDRUG

No specific change in the dopaminergic per os treatment

Per os dopaminergic treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 and more
  • Parkinson's disease according to UKPDSBB diagnosis criteria
  • Motor difficulties in spite of dopaminergic per os treatment
  • Not eligible for deep brain stimulation for one or more reasons (age\>70, axial troubles in spite of dopaminergic per os treatment, cognitive troubles and/or hallucinations)

You may not qualify if:

  • Mattis scale \< 120
  • Contraindication to Apomorphine (liver insufficiency, severe cognitive troubles, allergy, pregnancy, neuroleptic treatment)
  • Contraindication to Fluoro-Deoxy-Glucose which is used in PET-Scan (allergy, kidney failure, pregnancy, breast feeding)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rennes University Hospital

Rennes, 35000, France

Location

Related Publications (1)

  • Auffret M, Le Jeune F, Maurus A, Drapier S, Houvenaghel JF, Robert GH, Sauleau P, Verin M. Apomorphine pump in advanced Parkinson's disease: Effects on motor and nonmotor symptoms with brain metabolism correlations. J Neurol Sci. 2017 Jan 15;372:279-287. doi: 10.1016/j.jns.2016.11.080. Epub 2016 Dec 2.

    PMID: 28017228RESULT

Study Officials

  • Marc VERIN, MD PhD

    Rennes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2009

First Posted

December 24, 2009

Study Start

February 1, 2009

Primary Completion

February 1, 2014

Study Completion

February 1, 2015

Last Updated

May 24, 2023

Record last verified: 2023-05

Locations

FR(1)