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The DOI matches its Crossref record; 37 of the 37 references it cites were found in a registry or an index.

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

Moreau, Caroline, Odou, Pascal, Labreuche, Julien, Demailly, Alexandre, Touzet, Gustavo, Reyns, Nicolas, Gouges, Bastien, Duhamel, Alain, Barthelemy, Christine, Lannoy, Damien, Carta, Natacha, Palas, Benjamin, Vasseur, Michèle, Marchand, Felix, Ollivier, Thomas, Leclercq, Céline, Potey, Camille, Ouk, Thavarak, Baigne, Simon, Dujardin, Kathy, Carton, Louise, Rolland, Anne Sophie, Devedjian, Jean Christophe, Foutel, Véronique, Deplanque, Dominique, Fisichella, Matthieu, Devos, David·2025·Nature Medicine

Published version of a preprint

Abstract

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. ClinicalTrials.gov registration: NCT04332276 .

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Authors
Moreau, C., Odou, P., Labreuche, J., Demailly, A., Touzet, G., Reyns, N., Gouges, B., Duhamel, A., Barthelemy, C., Lannoy, D., Carta, N., Palas, B., Vasseur, M., Marchand, F., Ollivier, T., Leclercq, C., Potey, C., Ouk, T., Baigne, S., Dujardin, K., Carton, L., Rolland, A. S., Devedjian, J. C., Foutel, V., Deplanque, D., Fisichella, M., & Devos, D.
Venue
Nature Medicine
Published
2025-01-07
Volume
31
Issue
3
Pages
819-828
ISSN
  • 1078-8956
  • 1546-170X
Cited by
15
References
37
Language
en
Licence
Funders
InBrain Pharma

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