Clinical Trial on children and adolescents with autism spectrum disorders
We understand your desire to have as fast as possible a treatment which could improve your child’s autism spectrum disorder. However, the compound that we are currently developing does not at present have the marketing authorization for this indication. Thus, we have to conduct clinical trials so as to submit an application for a marketing authorization. In order to show the efficacy and tolerance of this new treatment, we have just completed a phase II clinical trial held in 6 centers across France (Brest, Limoges, Lyon, Marseille, Nice and Rouen). Preliminary results are promising and final results of the study are expected in June 2016. This study will be followed by a phase III clinical trial that, if successful, will allow to submit a registration application to the European health authorities.
As is the case in this type of studies, patients’ participation will follow a strict selection criteria defined in a clinical study protocol approved by regulatory authorities and which received a favorable opinion from an ethics committee. Such selection criteria might be, for example, the medical history or the severity of autism spectrum disorder. Therefore all patients will not be eligible for the clinical trial. This study will be a placebo randomized double blind study, meaning that some patients will receive an inactive compound (placebo) without them being aware of such information. The treatment duration will be 1 year, and all patients will receive the active treatment at least for 6 months. For the trial, between 150 and 200 patients (children and adolescents) will be recruited in France and in two other European countries.
If you want your child to take part in the next clinical trial, you can provide your personal details using the form below. With this information, Neurochlore will be able to put you in touch with the participating centers if you live near them.
Please be assured that we are doing our best to move forward as quickly as possible. We also want to take the opportunity to thank you for your support through all the emails we receive.
The Neurochlore team