Aprepitant in Anti-histamine-refractory Chronic Nodular Prurigo: A Multicentre, Randomized, Double-blind, Placebo-controlled, Cross-over, Phase-II trial (APREPRU)

Acta Derm Venereol. 2019 Apr 1;99(4):379-385. doi: 10.2340/00015555-3120.

Abstract

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).

Keywords: NK1 antagonist; chronic nodular prurigo; itch; neurokinin receptor 1; pruritus; substance P.

Publication types

  • Clinical Trial, Phase II
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Antipruritics / adverse effects
  • Antipruritics / therapeutic use*
  • Aprepitant / adverse effects
  • Aprepitant / therapeutic use*
  • Cross-Over Studies
  • Double-Blind Method
  • Drug Resistance
  • Female
  • Germany
  • Histamine Antagonists / therapeutic use*
  • Humans
  • Male
  • Middle Aged
  • Neurokinin-1 Receptor Antagonists / adverse effects
  • Neurokinin-1 Receptor Antagonists / therapeutic use*
  • Prurigo / diagnosis
  • Prurigo / drug therapy*
  • Prurigo / immunology
  • Quality of Life
  • Severity of Illness Index
  • Time Factors
  • Treatment Outcome
  • Young Adult

Substances

  • Antipruritics
  • Histamine Antagonists
  • Neurokinin-1 Receptor Antagonists
  • Aprepitant