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PRISM Study-Pruritus Relief Through Itch Scratch Modulation

NCT03497975 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 353

Last updated 2025-06-24

Study results available
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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.

Conditions

  • Prurigo Nodularis

Interventions

DRUG

Nalbuphine ER Tablets

Active Nalbuphine ER Tablets

DRUG

Placebo Tablets

Placebo matching NAL ER with no active substance

Sponsors & Collaborators

  • Trevi Therapeutics

    lead INDUSTRY

Principal Investigators

  • Chief Development Officer · Trevi Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-07
Primary Completion
2022-05-10
Completion
2023-02-24
FDA Drug
Yes

Countries

  • United States
  • Austria
  • France
  • Germany
  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03497975 on ClinicalTrials.gov