PRISM Study-Pruritus Relief Through Itch Scratch Modulation (PRISM)
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| ClinicalTrials.gov Identifier: NCT03497975 |
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Recruitment Status :
Completed
First Posted : April 13, 2018
Last Update Posted : May 6, 2023
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Sponsor:
Trevi Therapeutics
Information provided by (Responsible Party):
Trevi Therapeutics
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Brief Summary:
To investigate the anti-pruritic efficacy and safety of Nalbuphine Extended Release (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 Other: Matching Placebo Tablets | Phase 2 Phase 3 |
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 Extended Release (ER) (NAL 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) |
| Actual Enrollment : | 353 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 |
| Actual Primary Completion Date : | May 10, 2022 |
| Actual Study Completion Date : | February 24, 2023 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Active
162 mg nalbuphine ER tablets, BID
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Drug: Nalbuphine ER Tablets
Active Nalbuphine ER Tablets
Other Name: NAL ER Tablets |
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Placebo Comparator: Placebo
Matching placebo tablets
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Other: Matching Placebo Tablets
Matching Tablets with no active substance |
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Experimental: Open Label Extension
162 mg nalbuphine ER tablets, BID
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Drug: Nalbuphine ER Tablets
Open Label Extension
Other Name: NAL ER Tablets |
Primary Outcome Measures :
- Comparison of percentage of responders by arm [ Time Frame: 14 weeks ]To evaluate the effect of NAL ER on itch as assessed by the percentage of Responders ('response' is defined as a ≥ 4-point reduction in the 7-day average Worst Itch - Numerical Rating Scale [WI-NRS])
Secondary Outcome Measures :
- Change from baseline for itch-related quality of life: ItchyQoL total score [ Time Frame: 14 weeks ]To evaluate the effect of NAL ER on itch-related quality of life as assessed by the ItchyQoL total score
- Change from baseline for Prurigo Nodularis skin lesions [ Time Frame: 14 weeks ]To evaluate the effect of NAL ER on Prurigo Nodularis (PN) skin lesions as assessed by the Prurigo Activity Score (PAS) Question 5a
- Change from baseline for sleep disturbance [ Time Frame: at week 14 ]To evaluate the effect of NAL ER on sleep as assessed by the PROMIS Sleep Disturbance Short Form 8a
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Individuals diagnosed with generalized nodular PN, covering 2 separate body parts, and 10 or more pruriginous nodules
- Severe itch due to PN
- Age 18 years and older at the time of consent, and a life expectancy of at least 18 months.
- Individuals using antidepressants must be on a stable dose for a minimum of 4 weeks prior to screening.
Exclusion Criteria:
- Pruritus due to localized PN (only one body part affected), or less than 10 nodules
- Active, uncontrolled, pruritic dermatoses in need of treatment (such as atopic dermatitis or bullous pemphigoid for example).
- Unresolved acute secondary dermatoses active (unresolved) in the last (a) 4 weeks: localized contact dermatitis, environmental exposures, superficial burns, or viral exanthems; (b) 8 weeks: skin or environmental infestations, such as scabies, lice, or bed bugs.
- Other non-dermatologic diseases that could be a potential cause of concomitant pruritus (e.g., thyroid disease, celiac disease, hepatitis C virus [HCV]) must either have resolved, been successfully treated (i.e., HCV RNA negative) or must be successfully managed with stable, optimized treatment (e.g., thyroid replacement, dietary management with resolution of symptoms, respectively) for at least 3 months prior to screening
- History of a major psychiatric disorder such as bipolar disorder or schizophrenia. History of active substance abuse in the last 3 years.
- Known intolerance (GI, CNS symptoms) or hypersensitivity/drug allergy to opioids.
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Use of certain concomitant medications and treatments within a period prior to the study, or requirement for these medications during the study:
- Potential subjects taking opiates, gabapentin, pregabalin, calcineurin inhibitors, cannabinoid agonists, capsaicin, cryosurgery, topical doxepin, thalidomide or methotrexate, topical antihistamines or topical corticosteroids require a 14-day washout.
- Within 4 weeks prior to screening: ultraviolet (UV)-therapy, exposure to any investigational medication, including placebo
- Within 3 months prior to screening: Non-insulin biologics (including monoclonal antibodies) that modify the immune system,
- Individuals taking monoamine oxidase inhibitors are excluded, as concomitant opiate use may increase the risk for serotonin syndrome.
- Myocardial infarction or acute coronary syndrome within the previous 3 months, as reported by the subject.
- Individuals with prolonged QTcF
Individuals with HIV can be included if they meet the following criteria: (a) currently on a stable (> 6 months stable use) and well tolerated highly active antiretroviral therapy regimen; (b) CD4 count > 500 cells/mL; and (c) HIV ribonucleic acid (RNA) < 50 copies/mL documented for at least 6 months prior to enrollment.
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
Locations
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Sponsors and Collaborators
Trevi Therapeutics
Investigators
| Study Director: | David Clark, MD | Trevi Therapeutics |
| Responsible Party: | Trevi Therapeutics |
| ClinicalTrials.gov Identifier: | NCT03497975 |
| Other Study ID Numbers: |
TR11 |
| First Posted: | April 13, 2018 Key Record Dates |
| Last Update Posted: | May 6, 2023 |
| Last Verified: | January 2023 |
| 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:
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Pruritus Prurigo Skin Diseases Skin Manifestations Nalbuphine Analgesics, Opioid |
Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents |