Our family is running up… New centres have been involved in the study!

Mariangela — Fri, 22 Jul 2016 14:09:04 +0000

We are pleased to announce that two other French clinical centres have been involved in the GABA-1 study. The GABA-1 study has already 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 very soon, as all the questions raised by the ANSM will be satisfied within the first week of August 2016.

We warmly welcome the two Principal Investigators of the following centres, that will start screening patients in the very next few months:

Assistance Publique Hôpitaux de Paris – APHP, Hôpital d’enfants Armand Trousseau. Principal Investigator: Prof. Daniel Annequin

Assistance Publique Hôpitaux de Paris – APHP , Hôpital Bicêtre. Principal Investigator : Dr. Elisabeth Fournier-Charrière

Their patients will be enrolled at the Center of Clinical Investigations of the Hôpital Robert Debré Assistance Publique Hôpitaux de Paris – APHP.

We take this occasion to wish all of you happy summer holidays!

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Site Initiation Visits

Mariangela — Mon, 06 Jun 2016 17:29:06 +0000

The patients recruitment is close to start in France and in the Netherlands, where the 6 clinical sites (Hopital Robert Debré in Paris, Hopital Necker in Paris, Hopital La Timone in Marseille, Hopital Roger Salengro in Lille, Erasmus Universitair Medisch Centrum Rotterdam-Sophia Kinderziekenhuis in Rotterdam and University Medical Center Utrecht, Wilhelmina Kinderziekenhuis in Utrecht) will receive the SIV (Site Initiation Visit) in September 2016. The other 6 participating sites in Albania (Qendra Spitalore Universitare Nene Tereza), in Germany (Universitaetsklinikum Erlangen), in Greece (Geniko Nosokomeido Paidon I Agia Sofia) and in Italy (Azienda Ospedaliero – Universitaria Consorziale Policlinico di Bari, Azienda Ospedaliera di Padova and Istituto Giannina Gaslini) will receive the SIV in October 2016.

The site initiation visit (SIV) will be attended by the site principle investigator and his/her team of co-investigators and study nurses. During the SIV, the study staff will be trained in study conduct in accordance with Good Clinical Practice (GCP). With the release of the Investigational Medicinal Product (IMP), expected in August 2016, all the sites will be able to start recruitment of first eligible patients.

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recruiting centres – GAPP

Our family is running up… New centres have been involved in the study!

Site Initiation Visits