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

NCT06848348 · tracked via the Priya Life Science USA tracker

Sponsor

Dogwood Therapeutics Inc.

Phase

Phase 2

Started

2025-02-21

Last updated

2026-09-16

Condition(s) studied

Chemotherapy Induced Neuropathic PainChemotherapy Induced Pain NeuropathyChemotherapy Induced Pain

Investigational drug(s) / intervention(s)

HalneuronPlaceboHalneuron (Open Label Extension)

Halneuron: Halneuron for Subcutaneous Injection

Placebo: Placebo for Subcutaneous Injection

Halneuron (Open Label Extension): Halneuron for Subcutaneous Injection

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

NRS Pain — From enrollment to end of study at 4 weeks
Change from Baseline in the weekly average of daily 24-hour pain intensity scores analyzed by percentage of responders among patients treated with Halneuron compared to Placebo
Safety Assessments — From enrollment to end of study at 4 weeks
Incidence of serious adverse events (SAEs), adverse events (AEs) and Adverse Events of Special Interests (AESIs)

Trial sites (25)

Facility	City	Region
Central Recruiting Site	Sheffield	Alabama
Central Recruiting Site	Glendale	Arizona
Central Recruiting Site	Phoenix	Arizona
Central Recruiting Site	Fair Oaks	California
Central Recruiting Site	Fountain Valley	California
Central Recruiting Site	Los Angeles	California
Central Recruiting Site	Santa Rosa	California
Central Recruiting Site	Wheat Ridge	Colorado
Central Recruiting Site	Jacksonville	Florida
Central Recruiting Site	Jacksonville	Florida
Central Recruiting Site	Lakeland	Florida
Central Recruiting Site	Orlando	Florida
Central Recruiting Site	Port Charlotte	Florida
Central Recruiting Site	Tampa	Florida
Central Recruiting Site	Gurnee	Illinois
Central Recruiting Site	Lake Charles	Louisiana
Central Recruiting Site	Fenton	Missouri
Central Recruiting Site	Las Vegas	Nevada
Central Recruiting Site	Garden City	New York
Central Recruiting Site	Williamsville	New York
Central Recruiting Site	Winston-Salem	North Carolina
Central Recruiting Site	Houston	Texas
Central Recruiting Site	McAllen	Texas
Central Recruiting Site	Salt Lake City	Utah
Central Recruiting Site	Madison	Wisconsin

Other trials for the same condition

Helping Cancer Patients Manage Neuropathy Symptoms From Chemotherapy With a Low-Intensity, Low-Risk Cranial PEMF Device Enrolling by invitation

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06848348 on ClinicalTrials.gov ↗ ← All trials in the USA