The GABA-2 protocol entitled “randomized, double-blind, placebo controlled, multi-centre, superiority phase II study to evaluate the safety, pharmacokinetic, efficacy of gabapentin liquid formulation as add-on to morphine in children from 3 months to less than 18 years of age experiencing severe chronic neuropathic or mixed pain” has been finalised!
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!
