Evidence map›Paper›PMID 39775041›Full record

Trial reportNature medicine2025

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

Caroline Moreau, Pascal Odou, Julien Labreuche, Alexandre Demailly, Gustavo Touzet, Nicolas Reyns, Bastien Gouges, Alain Duhamel, Christine Barthelemy, Damien Lannoy and 17 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Nature medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04332276 (A New Concept of Continuous Dopaminergic Stimulation by Cerebroventricular Administration of A-dopamine), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04332276 phase1 / phase2completednot on this map

A New Concept of Continuous Dopaminergic Stimulation by Cerebroventricular Administration of A-dopamine (Dopamine Stored in Anaerobia) for Severe Motor Fluctuations in Parkinson's Disease?

TypeinterventionalSponsorUniversity Hospital, LilleRan2020 to 2024Enrolled12ConditionsParkinson DiseaseArmsA-dopamine, optimized oral treatment
3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
  4. Review
  5. Article
  6. Gene therapy downregulating CaV1.3 reverses motor disability in aged parkinsonian male and female macaques.Molecular therapy : the journal of the American Society of Gene Therapy · 2025
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

27 authors.

Caroline MoreauParkinson's Disease Centre of Excellence, Department of Neurology, Univeristy of Lille, CHU Lille, INSERM U1172-Degenerative & Vascular Cognitive Disorders, Lille, France.
Pascal OdouGRITA ULR 7365, University of Lille, Lille, France.
Julien LabreucheDepartment of Biostatistics, University of Lille, CHU de Lille, Lille, France.
Alexandre DemaillyInBrain Pharma, Lille, France.
Gustavo TouzetNeurosurgery Department, University of Lille, CHU Lille, Lille, France.
Nicolas ReynsNeurosurgery Department, University of Lille, CHU Lille, Lille, France.
Bastien GougesNeurosurgery Department, University of Lille, CHU Lille, Lille, France.ORCID http://orcid.org/0000-0002-6701-2888
Alain DuhamelDepartment of Biostatistics, University of Lille, CHU de Lille, Lille, France.
Christine BarthelemyPharmacy CHU Lille, Lille, France.
Damien LannoyGRITA ULR 7365, University of Lille, Lille, France.
Natacha CartaPharmacy CHU Lille, Lille, France.
Benjamin PalasPharmacy CHU Lille, Lille, France.
Michèle VasseurPharmacy CHU Lille, Lille, France.
Felix MarchandParkinson's Disease Centre of Excellence, Department of Neurology, Univeristy of Lille, CHU Lille, INSERM U1172-Degenerative & Vascular Cognitive Disorders, Lille, France.
Thomas OllivierParkinson's Disease Centre of Excellence, Department of Neurology, Univeristy of Lille, CHU Lille, INSERM U1172-Degenerative & Vascular Cognitive Disorders, Lille, France.
Céline LeclercqClinical Studies Pharmacovigilance Department, CHU Lille, Lille, France.ORCID http://orcid.org/0000-0002-0824-7943
Camille PoteyClinical Studies Pharmacovigilance Department, CHU Lille, Lille, France.
Thavarak OukClinical Studies Pharmacovigilance Department, CHU Lille, Lille, France.
Simon BaigneInBrain Pharma, Lille, France.
Kathy DujardinParkinson's Disease Centre of Excellence, Department of Neurology, Univeristy of Lille, CHU Lille, INSERM U1172-Degenerative & Vascular Cognitive Disorders, Lille, France.
Louise CartonDepartment of Medical Pharmacology, University of Lille, INSERM, CHU Lille, U1172-Degenerative & Vascular Cognitive Disorders, LilNCog, Lille Neuroscience & Cognition, LICEND, NS-Park Network, Lille, France.
Anne Sophie RollandDepartment of Medical Pharmacology, University of Lille, INSERM, CHU Lille, U1172-Degenerative & Vascular Cognitive Disorders, LilNCog, Lille Neuroscience & Cognition, LICEND, NS-Park Network, Lille, France.
Jean Christophe DevedjianDepartment of Medical Pharmacology, University of Lille, INSERM, CHU Lille, U1172-Degenerative & Vascular Cognitive Disorders, LilNCog, Lille Neuroscience & Cognition, LICEND, NS-Park Network, Lille, France.
Véronique FoutelInBrain Pharma, Lille, France.
Dominique DeplanqueClinical Studies Pharmacovigilance Department, CHU Lille, Lille, France.
Matthieu FisichellaInBrain Pharma, Lille, France.
David DevosParkinson's Disease Centre of Excellence, Department of Neurology, Univeristy of Lille, CHU Lille, INSERM U1172-Degenerative & Vascular Cognitive Disorders, Lille, France. david.devos@chru-lille.fr.ORCID http://orcid.org/0000-0002-2417-799X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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 .

Indexed as

Antiparkinson AgentsDopamineLevodopaParkinson DiseaseAgedAnaerobiosisCross-Over StudiesFemaleHumansMaleMiddle AgedAntiparkinson AgentsDopamineLevodopa

Identifiers

PMID39775041
PMCPMC11922744

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.