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This is a clinical trial (study), to be conducted in several clinical sites worldwide, of an oral study drug which will be investigated in adult patients with moderate to severe pruritus (itching) associated with Notalgia Paresthetica to assess if it's effective and safe.
EU CTIS ID: 2023-503957-36-00
What this study is testing
Part A: To evaluate three different doses of oral difelikefalin compared to placebo and select one dose for further investigation. Part B: To evaluate the efficacy of the selected dose of oral difelikefalin in reducing the intensity of itch after 8 weeks of treatment.
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- To be eligible for inclusion into the study, a patient must meet the following criteria: Has moderate to severe pruritus;
- Has at least a 6-month history of chronic pruritus due to NP;
- Presence of hyper- or hypopigmented macules, hyperkeratosis, lichenification, and/or excoriation in the middle to upper back in the vicinity of the scapula;
- Has NP-related pruritus that is considered appropriate for systemic therapy;
- Female subject is not pregnant or nursing during any period of the study.
You likely can't join if
- A patient will be excluded from the study if any of the following criteria are met: Subject has pruritus attributed to a cause other than NP;
- Has a history of skin disease or presence of skin condition other than those related to NP that, in the opinion of the Investigator, would interfere with the study assessments;
- Subject has any clinically significant medical condition or physical/laboratory/ECG/vital signs abnormality that would, in the opinion of the investigator, put the subject at undue risk or interfere with interpretation of study results.
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.