ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    prism | "Pruritus"
Previous Study | Return to List | Next Study

PRISM Study-Pruritus Relief Through Itch Scratch Modulation (PRISM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03497975
Recruitment Status : Recruiting
First Posted : April 13, 2018
Last Update Posted : August 23, 2018
Sponsor:
Information provided by (Responsible Party):
Trevi Therapeutics

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Prurigo Nodularis Drug: Nalbuphine ER Tablets Phase 2 Phase 3

Detailed Description:
This is a randomized, double-blinded, placebo-controlled, 2-arm study with an open label extension period following double-blind treatment, to investigate the anti-pruritic efficacy and safety of Nalbuphine ER tablets. Subjects will be randomized to NAL ER (2-week titration followed by 162 mg twice daily [BID] for 12 weeks) or matching placebo (14 weeks duration), with the primary endpoint evaluation at Week 14. During the open label extension, subjects who received NAL ER will continue on NAL ER total treatment duration 52 weeks including titration and subjects who received placebo will crossover to Nalbuphine ER Upon discontinuation of investigational product, all subjects will complete a 2-week off treatment Safety Follow-up Period, regardless of when and why the subject discontinued study treatment.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomized, double-blinded, placebo-controlled, 2-arm study with an open label extension period following double-blind treatment.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Matching Placebo
Primary Purpose: Treatment
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)
Actual Study Start Date : August 7, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Itching

Arm Intervention/treatment
Active Comparator: Active
162 mg nalbuphine ER tablets, BID
Drug: Nalbuphine ER Tablets
Active NAL ER Tablets or matching placebo
Other Name: Nalbuphine matching placebo tablets

Placebo Comparator: Placebo
Matching placebo tablets
Drug: Nalbuphine ER Tablets
Active NAL ER Tablets or matching placebo
Other Name: Nalbuphine matching placebo tablets




Primary Outcome Measures :
  1. A 4 point reduction in the Worst Itch Numerical Rating Scale (WINRS) at Week 14. (Responder = at least an improvement of 4 in WINRS score) [ Time Frame: 14 weeks ]
    Comparison of percentage responders by arm;


Secondary Outcome Measures :
  1. The change from baseline up to week 14 for WINRS up to Week 14 [ Time Frame: 14 weeks ]
    assessment of improvement from baseline

  2. The change from baseline up to week 14 for itchyQOL up to Week 14 [ Time Frame: 14 weeks ]
    assessment of improvement from baseline

  3. PBI-P, a simple analysis of covariance (ANCOVA) will be used to assess the change from baseline at Week 14. [ Time Frame: 14 weeks ]
    assessment of a subject's perception of their disease before and after treatment

  4. PAS: 1-category improvement from baseline in lesions with excoriations. [ Time Frame: at week 14 and at week 52 ]
    Assessment of number of subjects with 1-category improvement from baseline in lesions with excoriations.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03497975


Contacts
Contact: Clinical Ops Lead 2033042499 clinicalops.admin@trevitherapeutics.com

Locations
United States, Maryland
Dermatology and Skin Cancer Specialists, LLC dba US Dermatology Partners Not yet recruiting
Rockville, Maryland, United States, 20850
United States, New York
Forest Hills Dermatology Group Recruiting
Forest Hills, New York, United States, 11375
United States, North Carolina
Wake Research Associates, LLC Recruiting
Raleigh, North Carolina, United States, 27612
United States, Oklahoma
Central Sooner Research Not yet recruiting
Norman, Oklahoma, United States, 73071
United States, Pennsylvania
Paddington Testing Company Recruiting
Philadelphia, Pennsylvania, United States, 19103
Sponsors and Collaborators
Trevi Therapeutics

Responsible Party: Trevi Therapeutics
ClinicalTrials.gov Identifier: NCT03497975     History of Changes
Other Study ID Numbers: TR11
First Posted: April 13, 2018    Key Record Dates
Last Update Posted: August 23, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Pruritus
Prurigo
Neurodermatitis
Skin Diseases
Skin Manifestations
Signs and Symptoms
Dermatitis
Skin Diseases, Eczematous
Nalbuphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists