NCT Number: NCT01291537
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.
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Conditions
Age range
18 year–80 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
CH d'Aix en Provence, Aix-en-Provence, France
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
best médical treatment
DrugSponsors and collaborators
Lead sponsor
Poitiers University Hospital
Other
Registry information
Important dates
- Study start
- 2011
- Primary completion
- 2016
- First posted
- Feb 8, 2011
- Registry last updated
- Oct 11, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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