Clinical and Economic Impact of Duodopa: Long-term Effectiveness Study in Advanced Parkinson's Disease Patients
NCT ID: NCT01291537
Last Updated: 2016-10-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
56 participants
INTERVENTIONAL
2011-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Long-term Study of Duodopa (Levodopa/Carbidopa) in Advanced Parkinson's: Health Outcomes & Net Economic Impact
NCT00141518
Levodopa-Carbidopa Intestinal Gel Open-Label Study in Advanced Parkinson's Disease
NCT00335153
Study of the Effects of Dopaminergic Medications on Dopamine Transporter Density in Subjects With Parkinson's Disease
NCT00129181
Evolution of Hypodopaminergic Syndrome in Early Parkinson's Disease
NCT03141944
Effect of Deep Brain Stimulation on Neuropsychiatric Fluctuations in Patients With Parkinson's Disease
NCT04608123
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
TREATMENT
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Duodopa
Duodopa
Best medical treatment
best médical treatment
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Duodopa
best médical treatment
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Poitiers University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
CHU de POITIERS
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CH d'Aix en Provence
Aix-en-Provence, , France
Chu Amiens
Amiens, , France
Chu Clermont-Ferrand
Clermont-Ferrand, , France
Hôpital Henri Mondor
Créteil, , 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
Nîmes, , 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
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CECILE 2010-020769-25
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.