drugset / Trial / NCT03497975

PRISM Study-Pruritus Relief Through Itch Scratch Modulation

NCT03497975

Phase 2/3 Completed 353 enrolled Trevi Therapeutics
RandomizedParallel-groupQuadruple-blindTreatment

Summary

To investigate the anti-pruritic efficacy and safety of Nalbuphine Extended Release (ER) (NAL ER) tablets in Prurigo Nodularis. Participants were randomized to NAL ER (or matching placebo) with the primary endpoint evaluation at Week 14. During the open label extension, participants who received NAL ER were continued on NAL ER and participants who received placebo would then shift to NALER.

Timeline

Start
2018-08-07
Primary completion
2022-05-10
Completion
2023-02-24

Drugs

EvaluationDrugModalityDoseRoute
Subject Nalbuphine Small molecule 162 mg Oral

Indications