The primary objective is to assess the efficacy of gabapentin relative to tramadol for the treatment of moderate to severe chronic neuropathic or mixed pain by comparing the difference in average pain scores (assessed by age-appropriate pain scales) between intervention arms after 15 weeks of treatment. A total of 94 subjects will be randomised to receive gabapentin and tramadol placebo or tramadol and gabapentin placebo throughout 16-19 weeks (including 3 weeks of titration, 12 weeks of treatment at a stable dose and 1-4 weeks of tapering ). Participants aged from 3 months to <18 years of age with moderate to severe (≥4/10 in age-appropriate pain scales) chronic neuropathic or mixed pain will be recruited in 14 clinical sites in eight European countries.
MARIA TRAVERSO TRIAL
The trial is a multicentre, double-blind, double-dummy, randomised, active-controlled, non-inferiority trial. The GABA-1 trial aims to compare the efficacy and safety of gabapentin liquid formulation relative to tramadol and to explore the pharmacokinetics of both drugs in the treatment of chronic, neuropathic or mixed pain in the paediatric population. Gabapentin is currently used 'off-label' in children and adolescents with chronic neuropathic pain, and reliable evidence of its effects and optimal dosing are lacking. 13 Department of Pharmacology and Toxicology, Radboud Universiteit Faculteit der Rechtsgeleerdheid, Nijmegen, The Netherlands.12 Fondazione per la Ricerca Farmacologica Gianni Benzi onlus, Valenzano, Italy.11 Intensive Care and Department of Pediatric Surgery, Erasmus MC Sophia Children's Hospital, Rotterdam, The Netherlands.10 CVBF-Consorzio per le Valutazioni Biologiche e Farmacologiche, Pavia, Italy.9 Clinical Pharmacology and Therapeutics Group, University College London, London, UK.8 Department of Anaesthesia, Erasmus MC Sophia Children's Hospital & Center for Pain Medicine Rotterdam, Rotterdam, The Netherlands.6 PHARM - Pharmaceutical Research Management SRL, Lodi, Italy.5 UMR-1123 ECEVE, Université Paris Diderot, Sorbonne Paris Cité, Paris, France.4 AP-HP, Hôpital Robert Debré, Unité d'Epidémiologie Clinique, Paris, France.2 Université Paris Diderot, Sorbonne Paris Cité, Paris, France.
1 Department of Paediatric Pharmacology and Pharmacogenetics, AP-HP, Hôpital Robert Debré, Paris, France.Donjeta Bali, Alketa Hoxha, Ermira Kola, Inga Talvik, Juliette Andrieu-Galien, Celine Greco, Daniel Annequin, Justine Avez-Couturier, Romy Blanchet, Priscilla Boizeau, Brigitte Charron, Isabelle Desguerre, Sophie Dugue, Elisabeth Fournier-Charrière, Evelyne Jacqz-Aigrain, Cecile Mareau, Ivana Milovanovic, Barbara Tourniaire, Silvia Pontone, Chantal Wood, Antje Neubert, Regina Trollmann, Stefan Wimmer, Eleana Garini, Panagoula Mammi, Marcello Allegretti, Ornella Bellagamba, Franca Benini, Donato Bonifazi, Daniela Caprino, Sabrina Congedi, Francesco Craig, Sandro Dallorso, Antuan Divisic, Mariagrazia Felisi, Marco Gentile, Andrea De Giacomo, Luca Manfredini, Emilia Matera, Lucia Margari, Alessandro Mazza, Virgilio Pace, Chiara Di Pede, Maria Giuseppina Petruzzelli, Pieradelchi Ruffini, Luigina Tagliavacca, Maria Traverso, Anna Szumowska, Maarten O Mensink, Joost M Van Rosmalen, Tjitske Van Der Zanden, Patty Brouwer, Paul Healy, Daniel Howcutt, Helen Neary
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