Clinical trial NCT01291537: Clinical and Economic Impact of Duodopa: Long-term Effectiveness Study in Advanced Parkinson's Disease Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson's Disease
Keywords: Advanced
Severe form
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2011-02-08
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Aix en Provence
country: France
facility: CH d'Aix en Provence
city: Amiens
country: France
facility: Chu Amiens
city: Clermont-ferrand
country: France
facility: Chu Clermont-Ferrand
city: Creteil
country: France
facility: Hôpital Henri Mondor
city: Lille
country: France
facility: Chu Lille
city: Limoges
country: France
facility: Chu de Limoges
city: Lyon
country: France
facility: Chu de Lyon
city: Marseille
country: France
facility: Chu de Marseille
city: Nantes
country: France
facility: Chu de Nantes
city: Nice
country: France
facility: Chu de Nice
city: Nimes
country: France
facility: Chu de Nimes
city: Paris
country: France
facility: Ch Saint Antoine
city: Paris
country: France
facility: Ch La Pitie Salpetriere
city: Poitiers
country: France
facility: Chu de Poitiers
city: Rennes
country: France
facility: Chu de Rennes
city: Rouen
country: France
facility: Chu de Rouen
city: Saint Etienne
country: France
facility: Chu Saint Etienne
city: Strasbourg
country: France
facility: Chu de Strasbourg
city: Talence
country: France
facility: Chu Bordeaux
city: Toulouse
country: France
facility: Chu de Toulouse
Study officials:
References: