Study to Evaluate the Efficacy and Safety of Oral Difelikefalin for Moderate to Severe Pruritus in Subjects With Notalgia Paresthetica
Public ClinicalTrials.gov record NCT05978063. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A 2-part, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Oral Difelikefalin for Moderate-to-Severe Pruritus in Adult Subjects With Notalgia Paresthetica
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a 2-part, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of twice-daily (BID) oral difelikefalin for moderate-to-severe pruritus in adult subjects with NP.
Study identification
- NCT ID
- NCT05978063
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 214 participants
Conditions and interventions
Conditions
Interventions
- difelikefalin 2.0 mg tablets Drug
- difelikefalin 1.0 mg tablets Drug
- difelikefalin 0.25 mg tablets Drug
- Placebo tablets Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 1, 2023 (Actual)
- Primary completion
- Apr 22, 2024 (Actual)
- Completion
- May 7, 2024 (Actual)
- Last update posted
- Jun 21, 2024
2023 – 2024
United States locations
- U.S. sites
- 38
- U.S. states
- 19
- U.S. cities
- 37
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cara Therapeutics Study Site | Birmingham | Alabama | 35244 | — |
| Cara Therapeutics Study Site | Phoenix | Arizona | 85032 | — |
| Cara Therapeutics Study Site | Fayetteville | Arkansas | 72703 | — |
| Cara Therapeutics Study Site | Hot Springs | Arkansas | 71913 | — |
| Cara Therapeutics Study Site | Encino | California | 91436 | — |
| Cara Therapeutics Study Site | Fountain Valley | California | 92708 | — |
| Cara Therapeutics Study Site | Los Angeles | California | 90045 | — |
| Cara Therapeutics Study Site | Northridge | California | 91324 | — |
| Cara Therapeutics Study Site | Valencia | California | 91355 | — |
| Cara Therapeutics Study Site | Coral Gables | Florida | 33134 | — |
| Cara Therapeutics Study Site | Hollywood | Florida | 33021 | — |
| Cara Therapeutics Study Site | Lutz | Florida | 33558 | — |
| Cara Therapeutics Study Site | Margate | Florida | 33063 | — |
| Cara Therapeutics Study Site | Tampa | Florida | 33607 | — |
| Cara Therapeutics Study Site | Indianapolis | Indiana | 46250 | — |
| Cara Therapeutics Study Site | Plainfield | Indiana | 46168 | — |
| Cara Therapeutics Study Site | West Lafayette | Indiana | 47906 | — |
| Cara Therapeutics Study Site | Baton Rouge | Louisiana | 70808 | — |
| Cara Therapeutics Study Site | Baton Rouge | Louisiana | 70809 | — |
| Cara Therapeutics Study Site | Metairie | Louisiana | 70006 | — |
| Cara Therapeutics Study Site | New Orleans | Louisiana | 70115 | — |
| Cara Therapeutics Study Site | Rockville | Maryland | 20850 | — |
| Cara Therapeutics Study Site | Fort Gratiot | Michigan | 48059 | — |
| Cara Therapeutics Study Site | Reno | Nevada | 89509 | — |
| Cara Therapeutics Study Site | Portsmouth | New Hampshire | 03801 | — |
| Cara Therapeutics Study Site | Verona | New Jersey | 07044 | — |
| Cara Therapeutics Study Site | Fargo | North Dakota | 58103 | — |
| Cara Therapeutics Study Site | Boardman | Ohio | 44512 | — |
| Cara Therapeutics Study Site | Mason | Ohio | 45040 | — |
| Cara Therapeutics Study Site | Pittsburgh | Pennsylvania | 15213 | — |
| Cara Therapeutics Study Site | Charleston | South Carolina | 29425 | — |
| Cara Therapeutics Study Site | Thompson's Station | Tennessee | 37179 | — |
| Cara Therapeutics Study Site | Dallas | Texas | 75230 | — |
| Cara Therapeutics Study Site | Houston | Texas | 77056 | — |
| Cara Therapeutics Study Site | Pflugerville | Texas | 78660 | — |
| Cara Therapeutics Study Site | San Antonio | Texas | 78213 | — |
| Cara Therapeutics Study Site | Webster | Texas | 77598 | — |
| Cara Therapeutics Study Site | Spokane | Washington | 99202 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 20 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05978063, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 21, 2024 · Synced Oct 24, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05978063 live on ClinicalTrials.gov.