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

Phase 2

Completed

• Conditions: Parkinson's Disease
• Interventions: Drug: Duodopa; Drug: best médical treatment

• Registration Number: NCT01291537
• Lead Sponsor: Poitiers University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-02-07
• Study First Submitted QC: 2011-02-07
• Study First Posted: 2011-02-08
• Study Start: 2011-11
• Primary Completion: 2016-03
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-10
• Last Update Posted: 2016-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

Not provided

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

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Duodopa	Duodopa	-
Best medical treatment	best médical treatment	-

Trial Locations

Locations (20)

Chu de Nice; 🇫🇷 Nice, France

Chu Clermont-Ferrand; 🇫🇷 Clermont-ferrand, France

CH d'Aix en Provence; 🇫🇷 Aix en Provence, France

Chu de Marseille; 🇫🇷 Marseille, France

Chu de Nimes; 🇫🇷 Nimes, France

Chu Amiens; 🇫🇷 Amiens, France

Hôpital Henri Mondor; 🇫🇷 Creteil, France

Chu Lille; 🇫🇷 Lille, France

Chu de Lyon; 🇫🇷 Lyon, France

Chu de Limoges; 🇫🇷 Limoges, France

Chu de Nantes; 🇫🇷 Nantes, France

Ch Saint Antoine; 🇫🇷 Paris, France

Ch La Pitie Salpetriere; 🇫🇷 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, France