A Randomized, Double-Blind, Placebo Controlled, Multicenter Study With Optional Open-Label Extension to Evaluate the Efficacy and Safety Study of Halneuron in the Treatment of Chemotherapy-Induced Neuropathic Pain
Dogwood Therapeutics Inc.
Summary
A randomized study to determine safety and efficacy of a series of subcutaneous (SC) injections of HAL in patients with CINP, compared to matching placebo injections. After that, subjects may have the option to enter an Open Label extension phase, where available, in which all subjects will receive Halneuron.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Male or female patients aged ≥18 years. * Neuropathic pain has been present and is attributed to platinum and/or taxane chemotherapy. * Patient has received a cancer chemotherapy regimen that included taxanes and/or platinum and has no active or discernible disease progression. Exclusion Criteria: * Current neuropathic pain with symptoms similar to CINP but attributed to causes other than platinum or taxane chemotherapy. * Patients who have received HAL at any time prior to screening.