The GABA-1 Clinical Trial is close to start the enrolment, as the official authorization of the GABA-1 protocol has been received from the Dutch Ethics Committee.
The official approval of the Dutch METC Erasmus MC has been issued on July 28th, 2016, after that requests for clarification and some modifications concerning the informative packages for parent/legally authorized representative and protocol features were raised and all satisfied.
It is valid both for Rotterdam and Utrecht two sites “Erasmus Universitair Medisch Centrum Rotterdam-Sophia Kinderziekenhuis” and the “University Medical Center Utrecht, Wilhelmina Kinderziekenhuis”.
Hence, a pre study qualification visit in Rotterdam and in Utrecht is going to be prepared at the beginning of October, and the Site Initiation Visits (SIVs) will be performed as soon as the Investigational Medicinal Products (IMPs) will be available at each site.
The new pharmaceutical liquid formulation of Gabapentin has been produced by Dompè S.P.A., and will be then dispatched to the recruiting centres in the next few weeks.