← Back to Search

Open Label Extension for Prurigo Nodularis (PRISM Trial)

Phase 2 & 3
Waitlist Available
Research Sponsored by Trevi Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 weeks
Awards & highlights

PRISM Trial Summary

This trial is testing a new drug to see if it helps with a skin condition called Prurigo Nodularis.

Eligible Conditions
  • Prurigo Nodularis

PRISM Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Comparison of percentage of responders by arm
Secondary outcome measures
Change from baseline for Prurigo Nodularis skin lesions
Change from baseline for itch-related quality of life: ItchyQoL total score
Change from baseline for sleep disturbance

PRISM Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Open Label ExtensionExperimental Treatment1 Intervention
162 mg nalbuphine ER tablets, BID
Group II: ActiveExperimental Treatment1 Intervention
162 mg nalbuphine ER tablets, BID
Group III: PlaceboPlacebo Group1 Intervention
Matching placebo tablets
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nalbuphine ER Tablets
2018
Completed Phase 3
~360

Find a Location

Who is running the clinical trial?

Trevi TherapeuticsLead Sponsor
10 Previous Clinical Trials
1,034 Total Patients Enrolled
2 Trials studying Prurigo Nodularis
98 Patients Enrolled for Prurigo Nodularis
David Clark, MDStudy DirectorTrevi Therapeutics
4 Previous Clinical Trials
327 Total Patients Enrolled
William Forbes, PharmDStudy DirectorTrevi Therapeutics

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What other medical studies have utilized Active as a treatment?

"Active was first researched in 2008 at Tri-Service General Hospital. So far, there have been 36 completed studies with 6 more ongoing. A large portion of these studies are based in West Jordan, Utah."

Answered by AI

Could you please list all of the sites where this research is being conducted?

"This trial has 37 active recruitment sites, including Study Site 150 in West Jordan, Study Site 118 in Saint Joseph, and Study Site 159 in Hackensack, as well as other locations."

Answered by AI

How many people are receiving care as a part of this research project?

"This particular trial is not currently seeking new patients, as the last update to the posting was on November 1st, 2022. However, there are other trials (38 for pruritus and 6 for Active) that are still recruiting."

Answered by AI

What are the typical conditions that Active is used to alleviate?

"Active can provide pain relief for those going through childbirth, as well as for women in labor and during their post-operative recovery."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
PRISM Study-Pruritus Relief Through Itch Scratch Modulation
2018. "PRISM Study-Pruritus Relief Through Itch Scratch Modulation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03497975.
~53 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top