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

Poitiers University Hospital

Status and phase

Completed

Phase 2

Conditions

Parkinson's Disease

Treatments

Drug: best médical treatment

Drug: Duodopa

Study type

Interventional

Funder types

Other

Identifiers

NCT01291537

CECILE 2010-020769-25

Details and patient eligibility

About

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.

Enrollment

56 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.