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NCT06848348PHASE2Recruiting

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

Dogwood Therapeutics Inc.

Start Date

2/21/2025

Completion Date

8/1/2026

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 Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

Halneuron

DRUG

Placebo

DRUG

Halneuron (Open Label Extension)

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Conditions

Chemotherapy Induced Neuropathic PainChemotherapy Induced Pain NeuropathyChemotherapy Induced Pain

Locations

Central Recruiting Site

Sheffield, Alabama 35660

United States

Central Recruiting Site

Glendale, Arizona 85308

United States

Central Recruiting Site

Phoenix, Arizona 85022

United States

Central Recruiting Site

Fair Oaks, California 95628

United States

Central Recruiting Site

Fountain Valley, California 92708

United States

Central Recruiting Site

Los Angeles, California 91307

United States

Central Recruiting Site

Santa Rosa, California 95403

United States

Central Recruiting Site

Wheat Ridge, Colorado 80033

United States

Central Recruiting Site

Jacksonville, Florida 32205

United States

Central Recruiting Site

Jacksonville, Florida 32256

United States

Central Recruiting Site

Lakeland, Florida 33812

United States

Central Recruiting Site

Orlando, Florida 32832

United States

Central Recruiting Site

Port Charlotte, Florida 33952

United States

Central Recruiting Site

Tampa, Florida 33613

United States

Central Recruiting Site

Gurnee, Illinois 60031

United States

Central Recruiting Site

Lake Charles, Louisiana 70605

United States

Central Recruiting Site

Fenton, Missouri 63026

United States

Central Recruiting Site

Las Vegas, Nevada 89109

United States

Central Recruiting Site

Garden City, New York 11530

United States

Central Recruiting Site

Williamsville, New York 14221

United States

Central Recruiting Site

Winston-Salem, North Carolina 27103

United States

Central Recruiting Site

Houston, Texas 77346

United States

Central Recruiting Site

McAllen, Texas 78504

United States

Central Recruiting Site

Salt Lake City, Utah 84107

United States

Central Recruiting Site

Madison, Wisconsin 53715

United States