Aprepitant in Anti-histamine-refractory Chronic Nodular Prurigo: A Multicentre, Randomized, Double-blind, Placebo-controlled, Cross-over, Phase-II trial (APREPRU)
Athanasios Tsianakas, Claudia Zeidler, Claudia Riepe, Matthias Borowski, Caroline Forner, Joachim Gerss, Martin Metz, Petra Staubach, Ulrike Raap, Martin Kaatz, Marc Urban, Thomas A. Luger, Sonja Ständer
The aim of this multicentre, randomized, double-blind, placebo-controlled, cross-over, phase-II study was to determine the antipruritic effect of aprepitant vs. placebo in 58 patients with anti-histamine-refractory chronic pruritus in chronic nodular prurigo. Patients were randomized to receive either first oral aprepitant 80 mg/day or placebo for 4 weeks. Following a 2-week wash-out phase, the patients were crossed-over to receive the other treatment for 4 weeks. Primary efficacy criterion was the intra-individual difference between mean itch intensity (visual analogue scale) at baseline compared with the end of treatment period. Prurigo lesions, pruritus course, quality of life, patient benefits, and safety were secondary parameters. No significant differences were found between aprepitant treatment and placebo for any of the parameters investigated. Under the experimental conditions of the study, aprepitant, 80 mg daily for 4 weeks, did not have an antipruritic effect in patients with chronic prurigo. (DRKS00005594; EudraCT Number: 2013-001601-85).
Chronic nodular prurigo is characterized by multiple highly pruritic cutaneous nodules and a high impact on quality of life. The molecule substance P appears to play a significant role in the pathway of chronic pruritus. This randomized, double-blind, placebo-controlled, cross-over trial aimed to find out if using the drug aprepitant to block the substance P pathway could influence chronic pruritus in chronic nodular prurigo. However, the results showed no significant difference between aprepitant and placebo.