GABA-1 – GAPP

Green light in the Netherlands

user — Wed, 14 Sep 2016 12:24:08 +0000

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.

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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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The GABA-1 study has been approved!

Mariangela — Tue, 07 Jun 2016 17:08:41 +0000

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:

Hopital Robert Debré in Paris
Hopital Necker in Paris
Hopital La Timone in Marseille
Hopital Roger Salengro in Lille.

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:

Erasmus Universitair Medisch Centrum Rotterdam-Sophia Kinderziekenhuis in Rotterdam
University Medical Center Utrecht, Wilhelmina Kinderziekenhuis in Utrecht.

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!

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