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Intracerebroventricular anaerobic dopamine in Parkinson's disease with L-dopa-related complications: a phase 1/2 randomized-controlled trial.

Title: Intracerebroventricular anaerobic dopamine in Parkinson's disease with L-dopa-related complications: a phase 1/2 randomized-controlled trial.
Authors: Moreau, caroline; Odou, Pascal; Labreuche, Julien; Demailly, A.; Touzet, Gustavo; Reyns, Nicolas; Gouges, Bastien; Duhamel, Alain; Barthelemy, Christine; Lannoy, Damien; Carta, Natacha; Palas, Benjamin; Vasseur, Michele; Marchand, Felix; Ollivier, Thomas; Leclercq, Céline; Potey, Camille; Ouk, Thavarak; Baigne, S.; Dujardin, Kathy; Carton, Louise; Rolland, Anne-Sophie; Devedjian, Jean-Christophe; Foutel, V.; Deplanque, Dominique; Fisichella, M.; Devos, David
Contributors: Université de Lille; CHU Lille; Lille Neurosciences & Cognition - U 1172 LilNCog; Groupe de Recherche sur les formes Injectables et les Technologies Associées (GRITA) - ULR 7365; Centre Hospitalier Régional Universitaire CHU Lille CHRU Lille; Département de Neurochirurgie Lille; Service de Biostatistiques CHRU Lille; Groupe de Recherche sur les formes Injectables et les Technologies Associées - ULR 7365 GRITA; Equipe Alzheimer and Tauopathies - LilNCog U1172 Inserm; Lille Neurosciences & Cognition (LilNCog) - U 1172
Publisher Information: Springer Nature
Publication Year: 2025
Collection: LillOA (Lille Open Archive - Université de Lille)
Description: Continuous compensation for cerebral dopamine deficiency represents an ideal treatment for Parkinson’s disease. Dopamine does not cross the digestive and blood–brain barriers and is rapidly oxidized. The new concept is the intracerebroventricular administration of anaerobic dopamine (A-dopamine) using an abdominal pump connected to a subcutaneous catheter implanted in the third ventricle, near the striatum. An open-label phase 1 study showed no serious adverse reactions induced by A-dopamine in 12 patients. A randomized, controlled, open-label, crossover phase 2 study of 1 month of A-dopamine versus 1 month of optimized oral antiparkinsonian therapy was conducted in 9 patients. The primary endpoint, a blinded assessment of the percentage over target (that is, time with dyskinesia or bradykinesia), recorded by home actimetry using a wristwatch, was significantly reduced on A-dopamine compared with that on oral treatment alone (P = 0.027), with a median within-patient difference of −10.4 (Hedge g = −0.62 (95% confidence interval: −1.43, −0.08)). Home diaries were also significantly improved. These initial data on the feasibility, safety and effects of this new device-assisted therapy suggest validation by a large randomized double-blind trial.
Document Type: article in journal/newspaper
File Description: application/rdf+xml; charset=utf-8; application/octet-stream
Language: English
Relation: Nature Medicine; Nat Med; http://hdl.handle.net/20.500.12210/119308
Availability: https://hdl.handle.net/20.500.12210/119308
Rights: Attribution-NonCommercial-NoDerivs 3.0 United States ; info:eu-repo/semantics/openAccess
Accession Number: edsbas.E8A17A36
Database: BASE