A Randomized Double-Blind Study to Test Halneuron Injections for Treating Neuropathic Pain Caused by Chemotherapy with an Optional Open-Label Extension

What this Trial Is About

Researchers are evaluating the safety and effectiveness of Halneuron, given as a series of subcutaneous injections, for patients experiencing chemotherapy-induced neuropathic pain CINP. This randomized, double-blind, placebo-controlled Phase 2 study aims to compare Halneuron with placebo injections in managing pain caused by chemotherapy drugs such as platinum and taxane. Participants may have the option to continue in an open-label extension phase where all will receive Halneuron. Participants will be randomly assigned to receive either Halneuron or placebo by subcutaneous injection. After completing the randomized phase, those who choose to continue may enter an open-label extension where every participant receives Halneuron. The study includes careful monitoring during both phases to evaluate the treatments effects and safety. Throughout the study, participants will be closely monitored for pain levels using the Numeric Rating Scale NRS and safety assessments over a four-week period. Additional measurements include patient impressions of change, fatigue, sleep quality, and overall quality of life using standardized questionnaires. The total participation time includes the randomized phase and optional extension, providing ongoing evaluation of Halneurons impact on chemotherapy-induced neuropathic pain.

Efficacy and Safety Study of Halneuron in the Treatment of Chemotherapy-Induced Neuropathic Pain