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KOMFORT: Difelikefalin for Notalgia Paresthetica
NCT04706975Phase 2
Key facts
- Status
- Completed
- Start
- Jan 2021
- Primary completion
- May 2022
- Countries
- 2
- Sponsor
- Cara Therapeutics, Inc.
- Modality
- Peptides, Small Molecules
- Drugs
- difelikefalin
- Conditions
- notalgia paresthetica (NP)
01
Overview
Phase 2, randomised, double-blind trial in notalgia paresthetica (NP) comparing Difelikefalin 2.0 mg with Placebo (2 arms). Primary endpoint: Worst Itch-Numeric Rating Scale at 8 weeks. Started Jan 2021; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Difelikefalin 2.0 mg
Oral difelikefalin 2.0 mg BID
Placebo
Oral placebo BID
03
Who it enrols
Adult patients with a clinically confirmed diagnosis of active Notalgia Paresthetica and moderate to severe chronic pruritus.
04
Endpoints
Primary
Worst Itch-Numeric Rating Scale
Secondary
Skindex-10 Scale
Itch Medical Outcomes Study Sleep Disturbance Subscale
05
Results
Primary endpoints met
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