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

Parkinson's Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01291537
• Other study ID #: CECILE 2010-020769-25
• Status: Completed
• Phase: Phase 2
• First received: February 7, 2011
• Last updated: October 10, 2016
• Start date: November 2011

Study information

• Verified date: October 2016
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• Duodopa

• best médical treatment

Locations

Country	Name	City	State
France	CH d'Aix en Provence	Aix en Provence
France	Chu Amiens	Amiens
France	Chu Clermont-Ferrand	Clermont-ferrand
France	Hôpital Henri Mondor	Creteil
France	Chu Lille	Lille
France	Chu de Limoges	Limoges
France	Chu de Lyon	Lyon
France	Chu de Marseille	Marseille
France	Chu de Nantes	Nantes
France	Chu de Nice	Nice
France	Chu de Nimes	Nimes
France	Ch La Pitie Salpetriere	Paris
France	Ch Saint Antoine	Paris
France	Chu de Poitiers	Poitiers
France	Chu de Rennes	Rennes
France	Chu de Rouen	Rouen
France	Chu Saint Etienne	Saint Etienne
France	Chu de Strasbourg	Strasbourg
France	Chu Bordeaux	Talence
France	Chu de Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France,