Parkinson's Disease
Conditions
Keywords
Advanced, Severe form
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.
Interventions
DRUGDuodopa
DRUGbest médical treatment
Sponsors
Poitiers University Hospital
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Countries
France
Outcome results
None listed