News

Although the phase III clinical trial was a failure, Neurochlore was able to retrieve data that could be promising. Indeed, we are convinced that Bumetanide works on sub-populations, defined by more specific criteria that were not considered in the selection of the initial trial.

We have entered into a partnership with the company Quinten Health in order to re-analyze these clinical data using artificial intelligence in order to detect and define these sub-populations.

As part of this collaboration, and the GDPR law, we inform you that your health data will be reused.

Please find below the legal information note on this subject.

Information note on the re-use of your health data

“Bumetanide Phase 3 Rescue

Head of the study : Neurochlore

Scientific Director: Pr. Ben-Ari

Dear Sir or Madam,

Neurochlore will reuse the health data collected in the framework of the clinical study entitled SIGN 1&2 between September 24^th 2018 and October 26^th 2021. The purpose of the re-use of your health data is identical to that of the conduct of the study to which you have consented to evaluate the efficacity and the safety of bumetanide/S95008 in the improvement of Autism Spectrum Disorder core symptoms.

1) What is the purpose of this re-use and what does it involve?

The purpose of the re-use of your data is to perform a detailed analysis of the data collected in the Phase 3 study on Bumetanide. Neurochlore has therefore called upon Quinten Health (SAS, located at 08 rue Vernier in Paris (France) – 75017) in order to identify and characterize the profiles of patients showing the best response rates versus placebo and more generally to identify the causes of failure of the phase 3 study.

This project is based exclusively on the reuse and processing of medical information collected during the SIGN 1&2 study. The reuse of your data does not therefore involve any further examination or intervention on your part.

The data collected will not include your name. Your data will be identified by a confidentiality code and then analysed in an aggregate manner so that it will no longer be possible to identify you, either directly or indirectly. 

The results of this study may also be presented at scientific conferences and/or published in a scientific journal. 

In all cases, your anonymity will be preserved. You may be informed of the overall results of this study through Neurochlore at the following address: contact@neurochlore.fr.

2) What are your rights?

In accordance with the General Data Protection Regulation (RGPD-2016/679) and the provisions of the amended law on data processing, files and freedoms, you have the right to access, rectify, delete and limit your personal data. 

You also have the right to object. You may therefore, at any time and without justification, object to the re-use of your medical data in the context of this project. An objection will have no consequences in the structure you are consulting. 

You can exercise all your rights by writing to Neurochlore’s data protection officer at :

• by email to the adress  : ben-ari@neurochlore.fr ; 
• by post to :

Neurochlore – A l’attention de Yehezkel Ben-Ari,
Campus scientifique de Luminy
Bâtiment Beret-Delaage
Zone Luminy Entreprises Biotech
Case 922
163 Route de Luminy
13288 Marseille Cedex 09
FRANCE

You also have the right to lodge a complaint with the Commission Nationale de l’Informatique et des Libertés (CNIL), on the CNIL website or by post. 

Do not hesitate to ask any questions you may have by post to the following address: contact@neurochlore.fr.