We are pleased to announce that the GABA-1 study entitled “Randomized, double-blind, double-dummy, active controlled, multicentre, non-inferiority phase III study to compare the pharmacokinetic, efficacy and safety of gabapentin liquid formulation to tramadol in children from 3 months to less than 18 years of age experiencing moderate to severe chronic neuropathic or mixed pain” has been approved by the Ethics Committee (Comite de Protection des Personnes – Ile de France 1) in France, while the approval of the medicines agency (Agence nationale de sécurité du médicament et des produits de santé – ANSM) is expected within the end of July, if additional questions won’t be raised by the ANSM.
The following four French clinical centres will be formally opened as trial sites and will start recruiting in the very next few weeks:
The GABA-1 study has also received the approval from the Dutch Competent Authority, while the Ethic Committee (IRB) addressed many questions that will be answered in the following weeks, in order that the recruitment process can start also in the following 2 clinical sites:
Moreover, the study is under review by the Ethics Committees and Competent Authorities of the 3 Italian participating sites, while submission in Albania, Germany and Greece is underway.
According to the protocol, at least 94 patients will be enrolled in the study.
A big project milestone is close to be reached!
