NS-PARK launches Master Trial, France's first clinical trial platform to accelerate the identification of neuroprotective treatments for Parkinson's disease

A pioneering initiative for an urgent need

Parkinson's disease represents a major health issue, affecting over 11 million people worldwide, including more than 270,000 in France. With the aging of the population, this number could reach 360,000 by 2050. This progressive pathology, marked by motor disorders such as slowness, stiffness and tremors, leads to a progressive and significant loss of autonomy. Currently, the only treatments available are limited to relieving symptoms, not slowing the disease's progression.

Bolstered by its recent success in the LixiPark study, the results of which were recently published in The New England Journal of Medicine (NEJM), NS-PARK, an F-CRIN-labeled network, is launching Master Trial, the first French clinical trial platform dedicated to neurodegenerative diseases designed to accelerate the identification of neuroprotective treatments. A true innovation in the medical landscape: developed according to a model already proven in oncology and during the Covid-19 pandemic, this adaptive platform will, from 2026, enable the simultaneous testing of several drug candidates and significantly accelerate the validation of treatments aimed at slowing disease progression, while reducing costs and lead times.

An adaptive model with many benefits

The clinical trial will use a flexible protocol, based on a Bayesian statistical model allowing:

• A simultaneous evaluation of several treatments against a control group;
• Intermediate analyses to quickly integrate or discard molecules according to their efficacy;
• A rigorous follow-up of symptomsand progression markers over an 18-month period.

A major impact for patients, with results expected in 5 years instead of 8-10 years

This innovative model could reduce the time needed to identify effective therapies from 8-10 years to just 5 years. Priority will in fact be given to repositioning already existing drugs, such as lixisenatide, a treatment used in the case of diabetes, in order to bring solutions more quickly to patients, whose selection will be facilitated thanks to the databases and biobank of the NS-PARK network cohort. This cohort currently includes over 25,000 people being monitored in France.

Collaboration at the heart of this major project, with major partners

The set-up of this trial is based on collective work and the contribution of major partners in the healthcare field. It brings together 27 specialized French centers, as well as strategic partners such as Assistance Publique - Hôpitaux de Paris (AP-HP), Inserm, Institut du Cerveau (ICM), Biocluster Brain & Mind, CHU de Toulouse and the France Parkinson association. The collaboration is also part of an International Consortium involving Great Britain, the United States, Norway and Australia, with the formation of an international committee of experts to help select and prioritize the most promising drug candidates.

Patient partners are also stakeholders in this research. Committed alongside the France Parkinson association, which is steering this advisory group, they will be involved at every stage of the protocol. Their participation in the various working groups, as well as the consideration of their experiences, needs and expectations regarding this trial, is a relatively innovative aspect in France.

Investing in a major medical breakthrough

The trial is supported by the public authorities and the F-CRIN clinical research infrastructure; funding of 2.5 million euros has already been secured. The project aims to raise additional funds to expand the scope of the clinical trial, co-finance the comparison arms, and maximize its efficacy.

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