We are glad to inform you that the GABA-2 study entitled “Randomized, double-blind, placebo controlled, multi-centre, superiority phase II study to evaluate the safety, pharmacokinetic, efficacy of gabapentin liquid formulation as add-on to morphine in children from 3 months to less than 18 years of age experiencing severe chronic neuropathic or mixed pain” has been submitted through the Voluntary Harmonization Procedure (VHP) to the National Competent Authorities and Ethics Committee of the participating Member States (France, Germany, Italy and The Netherlands) and we received the Central Committee on Research Involving Human Subjects (CCMO) approval on April 4th, 2017. We will proceed with separate submission of the study protocol in Albania and Greece.
The Clinical Trial Authorisation has already been obtained in France by the Competent Authority, Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) and we are waiting for the approval of the Ethics Committee.
We are confident that the study will be quickly approved also in the other participating countries, according to the VHP procedure!
Another great result has been achieved!
The study aims to assess the efficacy of gabapentin combined with morphine compared to morphine alone and the drug exposure using sparse sampling techniques in children with severe chronic neuropathic or mixed pain persisting for at least 3 months.
According to the protocol, 66 patients will be enrolled in the study.
