Work Plan

WP 1 – Project Management

WP1 aims at providing, coordinating and managing the global framework for conduction of the Consortium involving 15 beneficiaries from 9 Countries. It is aimed at:

providing the project with a transparent and effective management structure to support efficient and timely implementation of the work plan;
supporting and facilitating collaboration and communication among partners;
providing resources, procedures and tools to facilitate monitoring of project milestones, objectives and results (financial and operative);
securing timely submission of reports and deliverables and effective communication with the European Commission.

WP Leader: CVBF

Involved Partner: CVBF

WP 2 – Scientific Coordination

This WP is aimed at:

providing the overall scientific coordination of the project across different countries and continuously assessing the degree of fulfilment of the studies’ scientific objectives;
establishing the independent bodies.

WP Leader: Rebecca Lundin, PENTA

Involved Partners: CVBF, EMC, PENTA, PB, PHARM, TUH, DOMPÉ, UCL, UKER, QSUNT, APHP, CCI, IGG, ASCH

WP 3 – Regulatory activities

WP3 entails:

the coordination and management of all activities aimed at obtaining the approval of the clinical trials in each recruitment site;
the setting up and management of pharmacovigilance activities;
the follow-up of the PIP procedure in view of a PUMA application.

WP Leader: Laura Mangiarini, CVBF

Involved Partners: CVBF, EMC, PENTA, PB, PHARM, TUH, DOMPÉ, UKER, QSUNT, APHP, IGG, ASCH

WP 4 – Trial Management

This WP deals with the management of the two clinical trials of the project GABA-1 and GABA-2, including activities such as drug management, data management, study monitoring and quality assurance.

WP Leader: Donato Bonifazi, PHARM

Involved Partners: CVBF, EMC, PENTA, PB, PHARM, TUH, DOMPÉ, UKER, QSUNT, APHP, IGG, ASCH

WP 5 – Development and preparation of the paediatric formulation

The aim of the present WP is:

to develop an oral liquid formulation of gabapentin to support the use of the product in the target paediatric patient population;
to develop placebo formulations for the conduction of GABA-1 and GABA-2 studies;
to perform a market analysis and an HTA.

WP Leader: Marco Gentile, DOMPÉ

Involved Partners: CVBF, PENTA, PEDIANET, PHARM, DOMPÉ

WP 6 – Juvenile toxicity study

The preGABA study is a juvenile repeated rat toxicity study to be conducted with the objective to investigate effects of gabapentin on the central nervous system development.

WP Leader: Marcello Allegretti, DOMPÉ

Involved Partners: PENTA, DOMPÉ

WP 7 – Efficacy and safety trial with gabapentin in moderate pain

The primary objective of this WP is to implement the GABA-1 clinical trial in order to evaluate the efficacy of gabapentin in the treatment of moderate chronic pain.
Secondary objectives are the evaluation of the safety and tolerability, the efficacy in improving the patient global assessment, the differences in maintaining efficacy between the two 15-week treatment periods, the PKPD relationship and the recommendation of the paediatric dose.

WP Leader: Florentia Kaguelidou, APHP

Involved Partners: CVBF, EMC, PENTA, PB, PHARM, TUH, DOMPÉ, UKER, QSUNT, APHP, CCI, IGG, ASCH

WP 8 – Efficacy and safety trial with gabapentin in severe pain

The primary objective of this WP is to evaluate the efficacy of gabapentin as adjunctive therapy to morphine in the treatment of severe chronic pain.
Secondary objectives are the assessment of the safety of gabapentin combined with morphine compared to morphine and of drug exposure in both arms using sparse sampling techniques.

WP Leaders: Saskia de Wildt, EMC

Involved Partners: CVBF, EMC, PENTA, PB, PHARM, TUH, DOMPÉ, UKER, QSUNT, APHP, CCI, IGG, ASCH

WP 9 – Bridging modelling study

WP9 deals with a bridging modelling study (GABA-3) and aims at demonstrating that the age subset 3 months – 3 years does not show significant differences in the underlying PKPD relationship, as compared to the source population.

WP Leader: Oscar Della Pasqua, UCL

Involved Partners: CVBF, EMC, PENTA, PB, PHARM, TUH, UCL, UKER, QSUNT, APHP, IGG, ASCH

WP 10 – Dissemination and knowledge management

The following objectives are addressed in the present WP:

Ensure efficient communication with stakeholders outside the project in order to raise awareness about activities and results.
Use the results of the project for a PUMA application and for market exploitation.

WP Leader: Luigi Comacchio, PEDIANET

Involved Partners: CVBF, PEDIANET, PHARM, CCI