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 meeting provided an update on the achievements and difficulties encountered toward the implementations of specific project tasks, the reasons for some delays and the mitigation strategies set into place in order to overcome such obstacles.

The meeting opened with an overview of the pharmaceutical company, Dompè, on the new liquid formulation specifications of Gabapentin as well as with a timeline for the drug production, setting the 3rd week of July as starting point, followed by packaging and final release from Quality Assurance.

Moreover, an update of the clinical studies has been provided, with a particular focus on:

• the description of the finalized GABA-1 protocol design, inclusion-exclusion criteria, study schedule, patient enrolment and eligibility criteria, study drug titration, optimization and end of study tapering;
• the description of the GABA-2 protocol highlighting the specificities of GABA-2 and the potential difficulties due to morphine handling and administration;
• the progression state of every Work Package (WP) and deliverables and a general update of GABA-3 study.

This meeting gave also the chance to discuss the main changes occurred in relation to the project plan and activities’ responsibilities.

The second meeting day provided an update on the GABA-1 Study management procedures, also including a full account about the informative consent set up for the study trials.

After presenting the web-based ICH-Good Clinical Practice Training Course, the organization of the trial infrastructure, that PHARM set in place for the management of GABA-1 and GABA-2, has been described. The meeting ended with the presentation of the e-CRF, created according to the study protocol in order to enable data to be systematically reviewed and analyzed, and a practical simulation on how data can be inserted in the e-CRF.

The meeting represented an excellent opportunity to foster fruitful scientific debates and to exchange information. Advancement in the work packages and partner involvements where discussed in order to build a perfect working basis for the forthcoming activities.

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The meeting provided an update on the achievements and difficulties encountered toward the implementations of specific project tasks, the reasons for some delays and the mitigation strategies set into place in order to overcome such obstacles, and dedicated specific session to the steps necessary for the implementation of the clinical studies.

With this specific aim, divided into six thematic sessions, the meeting allowed to address various aspects and issues of the gabapentin clinical development, such as protocols’ challenges and procedures, data management, clinical operations, dissemination and communication strategies as well as all the ethics and regulatory aspects.

The meeting represented an excellent opportunity to foster fruitful scientific debates and networking and to set project priorities. Indeed, it provided a great opportunity for exchanging information while discussing advancement in the work packages and partners’ involvement, in order to build up a perfect working basis for the forthcoming activities.

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Representatives of the project leader, Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF, Bari, Italy) and project partners from 9 different European and non‐European countries gathered in the kick-off meeting to set the general organisation and communication basis of what is considered to be a scientific challenge within pharmacological research: finding a new drug and its appropriate dosage to improve the lives of children under 18 suffering from chronic pain.

In particular, GAPP aims to study gapapentin, a drug for which a great therapeutic interest has already been demonstrated, and make it available on the market in order to improve the quality of life in children with chronic pain, a widespread but poorly recognised problem that is in most cases treated with drugs which are not approved or used off-label.

Not only requiring high expectations from professionally dedicated clinical trials but also from a social and communication area, as the population to whom it is addressed, it’s a sensitive and vulnerable research subject; the project is seen, according to all involved parties’ statements, as a hopeful, revolutionary endeavor aiming to relieve young patients of one of health dire issues: chronic pain.

Through the development of two appropriately controlled clinical trials (GABA-1 e GABA-2), sponsored by Pharmaceutical Research Management Srl (PHARM), as decided during the General Assembly in June 2014, the project will investigate appropriate dosages, efficacy and safety of this drug in the treatment of paediatric pain. If the results of the studies lead to positive results, gabapentin will be able to respond to an unmet therapeutic need. PHARM is also the Applicant of the PIP (EMEA-001310-PIP01-12) submitted to the PDCO for the development of gabapentin in paediatric chronic pain with neuropathic component and will coordinate the clinical operations for the conduction of the two clinical trials. The new formulation of gabapentin for paediatric use will be developed, produced and distributed to participating clinical centres by Dompé SpA, one of the main biopharmaceutical industries in Italy, that will also coordinate the nonclinical development of the juvenile toxicity study.

The GAPP Kick-off Meeting press release entitled “EU FP7 GAPP – GAbapentin in Paediatric Pain Project Kick-off. Toward new therapies to challenge chronic pain in children”, was published on CORDIS – Community Research and Development Information Services (for a list of press releases please visit the dedicated Press Releases section of this website).

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The project, which is financed under the 7th Framework Program for Research and Technological Development and will last 48 months at a total cost of more than 7 million Euro, is led by Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF). Its aims are to improve the quality of life in children affected by chronic pain, who in most cases are treated with drugs that lack commercial authorisation. “GAPP will not simply generate new clinical data, but it will also make a new drug available to everybody and it will do this through a special fund that the European Union has especially dedicated to explore the paediatric application of drugs that so far have only been tested and approved for use in adults.”, said Scientific Coordinator Adriana Ceci. “Among these is gabapentin, to which the GAPP project is dedicated and for which a great therapeutic interest has clearly emerged. An international network of experts to which the European Commission has decided to bestow its trust will cooperate to make this happen.”

Through the development of appropriately controlled clinical trials the project will investigate appropriate dosages, efficacy and safety of this drug in the treatment of paediatric pain thereby responding to a medical need that is currently unmet in the paediatric population. Dompé, one of the main biopharmaceutical industries in Italy, is the industrial project partner and the sponsor of the two clinical trials. Indeed, the group has long been involved  in the Research and Development of therapeutic solutions for rare pathologies, which often lack standard treatment, in such areas as ophthalmology, diabetology, organ transplant and oncology. “We are participating in this research project on paediatric pain with strong conviction”, explained Dompé CEO Eugenio Aringhieri. “It is a challenge of a high ethical value, which a far-reaching public-private partnership in terms of aims and therapeutic ambitions. The GAPP project therefore represents the best synthesis of this virtuous alliance and an innovative work frame, in which this collaboration becomes a true accelerator of the innovation at hand.

“The first problem to be solved when a child has to take a medicine is that an appropriate dosage is administered. The drug might be otherwise ineffective or provoke adverse effects. In GAPP we will identify an optimal dosage for even the smallest children by applying models based on adult or older children dosages (this is why one of the studies to be carried out is called ‘Bridging modelling study’). This way we will be able to minimize the participation of the youngest children in the clinical trial.”, clarified Prof. Oscar Della Pasqua of the University College London.

“The problem of children suffering from chronic pain is widespread, but poorly recognized and often undertreated,” explained Marteen O. Mensink, MD at the University Medical Centre Utrecht. “A specific form of pain in which the nervous system is involved is called neuropathic pain. Usually, normal pain killers have little or no effect on chronic neuropathic pain and doctors often resort to prescribing opioids like morphine in an attempt to reduce pain. The use of opioids, however, is associated with serious side effects. Gabapentin is a drug originally designed to reduce epileptic symptoms, but in adults it has shown to reduce neuropathic pain as well. This study project is aimed at assessing the efficacy of gabapentin in reducing chronic neuropathic pain in children. If children with chronic neuropathic pain meet the inclusion criteria, they will be randomized into receiving either an opioid or gabapentin.”

“Accessibility and information on good pain treatment is fundamental for all children in the world coping with chronic pain”, declared Patty Brouwer, International Services Manager at the International Confederation of Childhood Cancer Parent Organizations (ICCCPO), which will play an important role in the dissemination of the project activities and results.

So far, an assessment questionnaire has examined medical practices in Europe: “Thirteen European medical centres participated in a survey on the diagnosis and treatment of paediatric neuropathic pain for the purposes of the GAPP project. Since therapeutic strategies and potential of recruitment varied widely, a methodological and statistical group will be created to work on the standardisation of definitions and therapeutic schemes for the GABA1 and GABA2 trials.”, said Florentia Kaguelidou and Saskia de Wildt, both experienced paediatricians respectively at Assistance Publique-Hôpitaux de Paris and Erasmus MC Sophia Children’s Hospital.

The Project kick-off gathered a consortium of 15 partners to launch project activities and discuss the four-year scope of work. In particular, it was aimed to give all participants a better understanding of the project tasks and goals, illustrate the key elements of the clinical studies and related open issues, explore regulatory aspects specific to each country involved, and start the debates over the possible methodology and coordination structure in which the cooperation may evolve in the most beneficial and effective way. Intended joint actions and work packages of the project were fruitfully discussed in order to plan future actions.

_______________

Press enquiries:
Alessia Fabbri
e-mail: [email protected]
tel: +39.080.9751974

GAPP Project Partners:
1 CONSORZIO PER VALUTAZIONI BIOLOGICHE E FARMACOLOGICHE – CVBF, Italy
2 ERASMUS UNIVERSITAIR MEDISCH CENTRUM ROTTERDAM, The Netherlands
3 FONDAZIONE PENTA-FOR THE TREATMENT AND CARE OF CHILDREN WITH HIV-ONLUS, Italy
4 SOCIETA SERVIZI TELEMATICI SRL – PEDIANET Italy
5 AZIENDA OSPEDALIERO UNIVERSITARIA CONSORZIALE POLICLINICO DI BARI, Italy
6 PHARM – PHARMACEUTICAL RESEARCH MANAGEMENT SRL, Italy
7 SIHTASUTUS TARTU UELIKOOLI KLIINIKUM, Estonia
8 DOMPÉ SPA, Italy
9 UNIVERSITY COLLEGE LONDON, United Kingdom
10 UNIVERSITÄTSKLINIKUM ERLANGEN, Germany
11 QENDER SPITALORE UNIVERSITARE NENEA TIRANE, Albania
12 ASSISTANCE PUBLIQUE – HOPITAUX DE PARIS, France
13 CONFEDERACION INTERNACIONAL DE ORGANIZACIONES DE PADRES DE NINOS CON CANCER ASOCIACION, Spain
14 ISTITUTO GIANNINA GASLINI, Italy
15 GENIKO NOSOKOMEIO PAIDON ΑTHINON I AGIA SOPHIA – PAIDON PENTELIS,  Greece

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Introducing the meeting, Prof. Ceci underlined the importance of the project in the context of European funding and paediatric research, while Dr. Aringhieri outlined that the GAPP Project is very challenging and Dompé will provide its contribution.

The GAPP non-clinical studies covered the topics of the first session, while two other sessions dealt exclusively with the implementation of the clinical study. A clear working framework for the project was provided by the appointment of the GAPP project bodies.

This first Project Assembly saw the appointment of the GAPP Project Scientific Committee as well as of the Scientific Coordination Body composed by the Chair Dr. Dick Tibboel, Dr. Laura Mangiarini, Dr. Mariagrazia Felisi, Dr. Rebecca Lundin, Dr. Tijtske Van der Zanden.

Dr. Donato Bonifazi, Managing Director of the Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF) also informed the GA that the GAPP Ethics Board (EB), coordinated by CVBF through its Third Party Gianni Benzi Pharmacological Research Foundation (FGB), was appointed, with members Dr. Helen Sammons, Prof. Annagrazia Altavilla, Dr. Anouk Nijenhuis.

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The paediatric conference kicked-off with a confrontation between a group of young specialists and two important experts on oncohaematology (A. Biondi) and endocrinology (M. Maghnie). Many other important experts in the field took part in the debates. PEDIANET was among the exhibitors and handed out over 400 leaflets (Italian version and English version) to the paediatricians attending the event.

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As Prof. Adriana Ceci pointed out during the meeting, GAPP is a peculiar project, having to be compliant with two important reference documents: the Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and the rules and regulations of FP7 financed actions. She also underlined the requirement of completing a PIP (Paediatric Investigation Plan) for every new drug to be put on the market and the special Paediatric Use Marketing Authorisation (PUMA) which is GAPP’s final objective.

The meeting ended in the afternoon with a session on management and organizational issues, establishing timelines and clarifying responsibilities. The Managing Director of the Coordinator also underlined that the Project has been approved and hopefully the Grant Agreement with the European Commission will be subscribed soon. Starting date of the GAPP Project could be 01/07/2014, that is the first available date to ensure an optimum start of a hopeful, encouraging crusade against chronic pain.

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