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Clinical Trial Details for PRISM Study-Pruritus Relief Through Itch Scratch Modulation


Trevi Therapeutics
NCT ID: NCT03497975
Last Updated: August 21, 2018

The Study at a Glance

  • Status: Recruiting
  • Phase: 0
  • Gender: male
  • Age: 18 Years - N/A
  • Condition: Prurigo Nodularis
  • Study Type: Interventional
  • Intervention:
  • Lead Sponsor: Trevi Therapeutics
  • Location: Not Provided

Official Title

A Phase 2b/3, Randomized, Double-Blind, Placebo-Controlled, 2-Arm , Efficacy and Safety Study in Prurigo Nodularis (PN) With Nalbuphine ER Tablets for Pruritus Relief Through Itch Scratch Modulation (PRISM Study)

Purpose

To investigate the anti-pruritic efficacy and safety of Nalbuphine ER (NAL ER) tablets in Prurigo Nodularis. Subjects will be randomized to NAL ER (or matching placebo) with the primary endpoint evaluation at Week 14. During the open label extension, subjects who received NAL ER will continue on NAL ER and subjects who received placebo will crossover to NAL ER.

Eligibility

Ages Eligible for Study

18 Years to N/A

Sexes Eligible for Study

male

Accepts Healthy Volunteers

No

Criteria

Inclusion Criteria:

1. Individuals diagnosed with generalized nodular PN

2. Severe itch due to PN

3. Age 18 years and older at the time of consent, and a life expectancy of at least 18
months.

Exclusion Criteria:

1. Pruritus due to localized PN (only one body part affected)

2. Active, uncontrolled, pruritic dermatoses in need of treatment (such as atopic
dermatitis, bullous pemphigoid for example) or other dermatologic conditions that in
the opinion of the Investigator could confound the ability to assess PN related itch..

3. Exposure to any investigational medication, including placebo, within 4 weeks (3
months for biologics).

Additional Information, Locations & Contacts

Sponsors & Collaborators

Trevi Therapeutics

Investigators

Not Provided

Please refer to this study by its ClinicalTrials.gov identifier: NCT03497975

Location

Contacts

Dermatology and Skin Cancer Specialists, LLC dba US Dermatology Partners

Rockville, Maryland 20850

United States

Forest Hills Dermatology Group

Forest Hills, New York 11375

United States

Wake Research Associates, LLC

Raleigh, North Carolina 27612

United States

Central Sooner Research

Norman, Oklahoma 73071

United States

Paddington Testing Company

Philadelphia, Pennsylvania 19103

United States