Recruiting

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

NCT06848348 · Dogwood Therapeutics Inc.

Recruiting

In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

Official title

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

About this study

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 criteria

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.

Study design

Enrollment target: 240 participants

Allocation: randomized

Masking: quadruple

Age groups: adult, older_adult

Timeline

Starts: 2025-02-21

Estimated completion: 2026-08

Last updated: 2026-05-29

Interventions

Drug: HalneuronDrug: PlaceboDrug: Halneuron (Open Label Extension)

Primary outcomes

• NRS Pain (From enrollment to end of study at 4 weeks)
• Safety Assessments (From enrollment to end of study at 4 weeks)

Sponsor

Dogwood Therapeutics Inc. · industry