NoTOPain was a randomised, crossover, placebo controlled, double-blind, Phase II study of cetuximab in patients with treatment-refractory, non-malignant severe chronic neuropathic pain. Neuropathic pain is a subtype of pain that can be caused by a variety of pathological processes that directly affect the sensory nervous system.
This trial was a proof of concept study with a single study site at the Sørlandet Sykehus, Kristiansand hospital in Norway. The Kristiansand hospital fulfilled the dual role of Sponsor and Investigator Site for this study.
Frontier Science undertook a wide scope of work for this study including randomisation; data management; collaboration in protocol development; statistical design, analysis and reporting and trial monitoring. Results have been published https://doi.org/10.1093/pm/pnz101.