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NCT05978063 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate the Efficacy and Safety of Oral Difelikefalin for Moderate to Severe Pruritus in Subjects With Notalgia Paresthetica
A Phase 2 study, sponsored by Cara Therapeutics.
- Terminated
- Registry status
- Phase 2
- Development phase
- 214
- Enrollment target
NCT05978063: Clinical Trial Phase 2 study, sponsored by Cara Therapeutics.
NCT05978063 is a Phase 2 study that was terminated before completion, run by Cara Therapeutics. The registered enrollment target is 214 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (61% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05978063, a Phase 2 study, was terminated before completion, sponsored by Cara Therapeutics.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 214 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Placebo tablets
- DRUG difelikefalin 2.0 mg tablets
- DRUG difelikefalin 1.0 mg tablets
- DRUG difelikefalin 0.25 mg tablets
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 214 participants |
| Start Date | 2023-08-01 |
| Est. Completion | 2024-05-07 |
| Phase | Phase 2 |
Why NCT05978063 stopped before completion
NCT05978063 is an interventional study that assigns participants to a tested intervention. The registered 214 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (61% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo tablets is the first listed.
NCT05978063 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05978063 about?
NCT05978063 is a clinical study titled "Study to Evaluate the Efficacy and Safety of Oral Difelikefalin for Moderate to Severe Pruritus in Subjects With Notalgia Paresthetica". 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.
What is the current status of trial NCT05978063?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 214 participants. The study started on 2023-08-01. Estimated completion is 2024-05-07.
What interventions are being tested in trial NCT05978063?
The interventions under investigation include: Placebo tablets (DRUG), difelikefalin 2.0 mg tablets (DRUG), difelikefalin 1.0 mg tablets (DRUG), difelikefalin 0.25 mg tablets (DRUG).
Who is sponsoring clinical trial NCT05978063?
This trial is sponsored by Cara Therapeutics, which has 23 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05978063's enrollment target sits among peer trials
214 290th of 2000 higher than 1,711 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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