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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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!

The post The GABA-1 study has been approved! appeared first on GAPP.

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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This protocol has proven to be particularly challenging due to the different morphine formulations and practices in the management of pain in the different countries (and even in the different clinical centres). A lot of work has been directed into the harmonisation and definition of a commonly acceptable protocol which now allows the use of both liquid and solid immediate release formulations as well as extended release tablets. We hope that this will maximise the potential for inclusion of children affected by severe chronic pain of neuropathic origin!

The regulatory process for the approval of GABA-2 has initiated!

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