Peripheral KV7 Activation for Pain Relief

Summary

The goal of this clinical trial is to learn if the drug Flupirtine can safely lower pain when used in tiny amounts directly in the skin. The study will test whether Flupirtine works by activating specific nerve channels in the skin called KV7 potassium channels. These channels help control how pain signals travel to the brain. The main questions the study aims to answer are: * Does Flupirtine lower pain caused by capsaicin, the active ingredient in chili peppers? * Does Flupirtine lower pain caused by heat? Researchers will compare Flupirtine to a placebo (a look-alike injection that does not contain any drug) to see if Flupirtine lowers pain better than the placebo. Participants will: * Receive tiny skin injections that contain either Flupirtine, capsaicin, heat, or placebo * Rate their pain on a scale from 0 (no pain) to 100 (worst pain imaginable) * Complete all study procedures during one visit that lasts about 1 hour Only a small amount of Flupirtine will be used in this study-less than 1/800 of the usual dose. The drug is injected into the skin, not taken by mouth. Because of this, the risk of side effects is extremely low. This study includes healthy adults between the ages of 18 and 70. It does not include people who are pregnant, taking medications, or who have skin or nerve problems. The goal is to find out if Flupirtine can be used in the future to treat pain in a new way-by working directly in the skin and not in the brain. This could help avoid side effects like tiredness or dizziness. The study is sponsored by the Medical University of Vienna and follows all safety and ethical rules.

Timeline

Start

2025-05-08

Primary completion

2025-05-28

Completion

2025-05-28

Publications

• Background Heber S, Resch F, Ciotu CI, Gleiss A, Heber UM, Macher-Beer A, Bhuiyan S, Gold-Binder M, Kain R, Sator S, Fischer MJM. Human heat sensation: A randomized crossover trial. Sci Adv. 2024 Sep 6;10(36):eado3498. doi: 10.1126/sciadv.ado3498. Epub 2024 Sep 4.
• Background Heber S, Gold-Binder M, Ciotu CI, Witek M, Ninidze N, Kress HG, Fischer MJM. A Human TRPA1-Specific Pain Model. J Neurosci. 2019 May 15;39(20):3845-3855. doi: 10.1523/JNEUROSCI.3048-18.2019. Epub 2019 Mar 12.
• Background Heber S, Ciotu CI, Hartner G, Gold-Binder M, Ninidze N, Gleiss A, Kress HG, Fischer MJM. TRPV1 antagonist BCTC inhibits pH 6.0-induced pain in human skin. Pain. 2020 Jul;161(7):1532-1541. doi: 10.1097/j.pain.0000000000001848.

Drugs

Indications

No indication recorded.