Clinical and Economic Impact of Duodopa: Long-term Effectiveness Study in Advanced Parkinson's Disease Patients

Study Overview
=================
Brief Summary
-----------------
The goal of this multicentric prospective randomized controlled clinical and economic study is to investigate the effectiveness and cost-utility of long-term continuous intraduodenal infusion of levodopa ( DUODOPA), compared to best medical treatment, on advanced and severe form of Parkinson's disease.

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Drug: Duodopa
* Drug: best médical treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria : Age> 18 years and ≤ 80 years Akineto-hypertonic and/or tremor forms of Parkinson's disease as defined by the criteria of the French National Consensus conference for Parkinson's disease (March 2000) Absence of parkinsonism other than a Parkinson's disease, including absence of one or more of the following signs: autonomic syndrome, hallucinations, pyramidal signs, early postural instability, early cognitive impairment (including apraxia or severe frontal lobe syndrome) (Consensus Conference, March 2000) Severe and advanced forms of Parkinson's disease with sensitivity to L-dopa (≥ 40%) No contraindication to Duodopa®: hypersensitivity to levodopa and carbidopa, or any of the excipients, angle-closure glaucoma, kidney and liver failures, severe heart failure, severe cardiac arrhythmia, acute stroke, pheochromocytoma, hyperthyroidism, Cushing syndrome, association with non-selective MAOIs and selective MAOIs-A (stop at least 2 weeks before initiation of Duodopa®) Fluctuations in motor performance (with OFF time ≥ 2 hours per day) and/or dyskinesia induced by L-DOPA altering significantly the activities of daily life in spite of an optimized treatment Hoehn and Yahr score < 4 in best ON Ability to complete a diary of self-evaluation (with the help of another person if necessary) MMSE ≥ 24/30 No evolutive psychosis or history of severe psychosis requiring hospitalization No digestive disease or ENT evolutionary No concomitant treatment by continuous infusion of apomorphine No concomitant treatment by deep brain stimulation No serious somatic disease likely to interfere with a good participation to the study, contraindication for gastrostomy Menopause proven or woman of childbearing potential with an effective contraception (hormonal / mechanical: oral, injectable, transdermal, implantable, intrauterine device, or surgery: ligation of the fallopian tubes, hysterectomy, total ovariectomy) Exclusion Criteria: Age <18 and> 80 years No signature of the informed consent form Patient with no social insurance or who cannot benefit it through a third person in accordance with the French law on biomedical research Population under enhanced protection (i.e minors), pregnant women, breast-feeding women, persons deprived of their liberty by a judicial or administrative decision, people in health and social service, adults under legal protection, and finally patients in emergency situations.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Duodopa<br> | Drug: Duodopa<br> <br> |
| Active Comparator: Best medical treatment<br> | Drug: best médical treatment<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Advanced, Severe form