In short
Currently, there is one ongoing clinical trial investigating treatments for notalgia paraesthetica, a chronic condition that causes intense itching on the upper back. The trial is testing an oral medication called difelikefalin and is being conducted across three European countries: Germany, Poland, and Spain.
Clinical trial locations
- Germany
- Poland
- Spain
Study on the Effectiveness and Safety of Difelikefalin for Adults with Moderate-to-Severe Itching from Notalgia Paresthetica
This clinical trial is investigating a potential treatment for adults experiencing moderate to severe itching caused by notalgia paraesthetica. The study focuses on testing difelikefalin, an oral medication that works as a kappa-opioid receptor agonist, meaning it interacts with specific receptors in the body to help reduce the sensation of itching.
Main inclusion criteria:
- Patients must experience moderate to severe itching (known medically as pruritus)
- The chronic itching must have been present for at least six months due to notalgia paraesthetica
- Patients must have visible skin changes in the middle to upper back area near the shoulder blades, which may include darker or lighter spots, thickened skin, hardened skin, or scratches
- The itching must be suitable for systemic therapy, meaning treatment that affects the whole body rather than just applying creams to one area
- Female patients must not be pregnant or nursing during the study period
Main exclusion criteria:
- History of severe allergic reactions to the study medication or similar drugs
- Currently participating in another clinical trial
- Medical conditions that study doctors believe could interfere with the results
- Pregnancy or breastfeeding
- History of drug or alcohol abuse within the past year
- Significant mental health disorder that is not well controlled
- Serious infection or illness requiring hospitalization
- Major surgery within the past month
- Inability to follow study procedures or instructions
Focus and goals of the trial:
The study is divided into two main parts. In Part A, researchers will compare three different doses of difelikefalin against a placebo to determine which dose is most effective at reducing itching. The medication is taken orally as a tablet.
In Part B, the dose selected from the first part will be tested further over an eight-week period to evaluate how well it reduces itch intensity. Researchers will monitor various factors including improvements in itching symptoms and any changes in other skin sensations such as burning or tingling.
Throughout the study, participants will take the medication daily, and regular assessments will be conducted to monitor itch intensity, skin condition, and any adverse effects. The goal is to identify a safe and effective dose of difelikefalin that can help alleviate the discomfort caused by this chronic condition. At the end of the eight-week treatment period, researchers will evaluate the medication's effectiveness based on improvements in itch scores and skin condition, followed by a follow-up period to assess any effects after treatment stops.
Investigational drug: Difelikefalin is the medication being tested in this trial. It is administered orally in tablet form and is designed to reduce moderate to severe itching in adults with notalgia paraesthetica.
Summary
There is currently one active clinical trial for notalgia paraesthetica, taking place across three European countries: Germany, Poland, and Spain. The trial focuses on testing difelikefalin, an oral medication that targets specific receptors to reduce itching sensations. The study aims to determine the optimal dose of this medication and evaluate its safety and effectiveness over an eight-week treatment period.
Notalgia paraesthetica is a chronic condition that causes persistent itching, typically on the upper back, often accompanied by burning or tingling sensations. The condition can significantly impact quality of life, and this trial represents an important step in exploring new treatment options for those affected. Participants in the study must have experienced moderate to severe symptoms for at least six months and show visible skin changes in the affected area.
The trial's two-part design allows researchers to carefully evaluate different doses before conducting a more extensive effectiveness assessment, demonstrating a methodical approach to understanding how this new medication might help patients manage their symptoms.
