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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Poitiers University Hospital
• Treatments: Carbidopa, levodopa drug combination

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.