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

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.

Study Overview

• Status: Completed
• Conditions: Parkinson's Disease
• Intervention / Treatment: Drug: Duodopa; Drug: best médical treatment

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Aix en Provence, France, 13616
    • CH d'Aix en Provence
  • Amiens, France
    • CHU Amiens
  • Clermont-ferrand, France, 63003
    • Chu Clermont-Ferrand
  • Creteil, France, 94010
    • Hopital Henri Mondor
  • Lille, France, 59037
    • Chu Lille
  • Limoges, France, 87000
    • CHU de Limoges
  • Lyon, France, 69229
    • CHU de Lyon
  • Marseille, France, 13354
    • CHU de Marseille
  • Nantes, France, 44035
    • CHU de Nantes
  • Nice, France, 06003
    • Chu de Nice
  • Nimes, France, 30029
    • CHU de Nîmes
  • Paris, France, 75571
    • Ch Saint Antoine
  • Paris, France, 75651
    • Ch La Pitie Salpetriere
  • Poitiers, France, 86021
    • CHU De Poitiers
  • Rennes, France, 35033
    • CHU de Rennes
  • Rouen, France, 76031
    • CHU de ROUEN
  • Saint Etienne, France, 42055
    • CHU Saint Etienne
  • Strasbourg, France, 67091
    • CHU de Strasbourg
  • Talence, France, 33404
    • CHU Bordeaux
  • Toulouse, France, 31059
    • CHU de Toulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Best medical treatment	Drug: best médical treatment
Experimental: Duodopa	Drug: Duodopa

Collaborators and Investigators

• Sponsor: Poitiers University Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: February 7, 2011
• First Submitted That Met QC Criteria: February 7, 2011
• First Posted (Estimate): February 8, 2011

Study Record Updates

• Last Update Posted (Estimate): October 11, 2016
• Last Update Submitted That Met QC Criteria: October 10, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Advanced; Severe form
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Immunologic Factors; Dopamine Agonists; Dopamine Agents; Adjuvants, Immunologic; Antiparkinson Agents; Anti-Dyskinesia Agents; Carbidopa, levodopa drug combination
• Other Study ID Numbers: CECILE 2010-020769-25