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Papers of the Week


2022 Aug 26


Contemp Clin Trials

Design of a randomized, placebo-controlled, phase 2 study evaluating the safety and efficacy of tanezumab for treatment of schwannomatosis-related pain.

Authors

Da JLW, Merker VL, Jordan JT, Ly IK, Muzikansky A, Parsons M, Wolters PL, Xu L, Styren S, Brown MT, Plotkin SR
Contemp Clin Trials. 2022 Aug 26:106900.
PMID: 36038003.

Abstract

Schwannomatosis (SWN) is a rare tumor suppressor syndrome that predisposes affected individuals to develop multiple schwannomas and, less often, meningiomas. The most common symptom is chronic, severe pain. No medications are broadly effective in treating SWN-associated pain. The clinical trial described in this manuscript is a phase 2, randomized, double-blind, placebo-controlled study investigating the safety and efficacy of tanezumab – a humanized monoclonal antibody that inhibits nerve growth factor – for treatment of SWN-related pain. As the first therapeutic trial for SWN-related pain, it also aims to evaluate trial endpoints, understand recruitment patterns, and improve clinical trial design in this rare disease.