Difelikefalin for Itching

Recruiting in Palo Alto (17 mi)

+57 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: Cara Therapeutics, Inc.

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This trial is testing a new oral medication called difelikefalin to see if it can help adults who suffer from severe itching. The medication works by blocking the signals that cause itching. The study will compare different doses to find the most effective one and ensure it is safe for long-term use. Difelikefalin was first approved in the USA for treating severe itching in adults undergoing hemodialysis.

Eligibility Criteria

This trial is for adults with chronic itching due to Notalgia Paresthetica (NP), who experience moderate to severe pruritus. Participants must not be pregnant or nursing and should have a confirmed diagnosis of active NP. Those with medical conditions that could risk their safety or affect the study's results are excluded.

Inclusion Criteria

I have itching on the upper middle part of my back.

I am not pregnant or breastfeeding.

I often have moderate to severe itching.

+2 more

Exclusion Criteria

My itching is not due to Notalgia Paresthetica.

Participant Groups

The study tests three different doses of oral difelikefalin tablets (0.25 mg, 1.0 mg, and 2.0 mg) against placebo tablets to assess their effectiveness and safety in treating itchiness from NP when taken twice daily.

4Treatment groups

Active Control

Placebo Group

Group I: Difelikefalin 0.25 mg tabletsActive Control1 Intervention

Oral difelikefalin 0.25 mg tablet administered twice daily

Group II: Difelikefalin 2.0 mg tabletsActive Control1 Intervention

Oral difelikefalin 2.0 mg tablet administered twice daily

Group III: Difelikefalin 1.0 mg tabletsActive Control1 Intervention

Oral difelikefalin 1.0 mg tablet administered twice daily

Group IV: Placebo tabletsPlacebo Group1 Intervention

Oral placebo tablet administered twice daily