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

May 27, 2026 updated by: Dogwood Therapeutics Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

240

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Dogwood Therapeutics
  • Phone Number: 866-620-9255
  • Email: Mehran@dwtx.com

Study Locations

  • United States
    • Alabama
      • Sheffield, Alabama, United States, 35660
        • Recruiting
        • Central Recruiting Site
    • Arizona
      • Glendale, Arizona, United States, 85308
        • Recruiting
        • Central Recruiting Site
      • Phoenix, Arizona, United States, 85022
        • Recruiting
        • Central Recruiting Site
    • California
      • Fair Oaks, California, United States, 95628
        • Recruiting
        • Central Recruiting Site
      • Fountain Valley, California, United States, 92708
        • Recruiting
        • Central Recruiting Site
      • Los Angeles, California, United States, 91307
        • Recruiting
        • Central Recruiting Site
      • Santa Rosa, California, United States, 95403
        • Recruiting
        • Central Recruiting Site
    • Colorado
      • Wheat Ridge, Colorado, United States, 80033
        • Recruiting
        • Central Recruiting Site
    • Florida
      • Jacksonville, Florida, United States, 32205
        • Recruiting
        • Central Recruiting Site
      • Jacksonville, Florida, United States, 32256
        • Recruiting
        • Central Recruiting Site
      • Lakeland, Florida, United States, 33812
        • Recruiting
        • Central Recruiting Site
      • Orlando, Florida, United States, 32832
        • Recruiting
        • Central Recruiting Site
      • Port Charlotte, Florida, United States, 33952
        • Recruiting
        • Central Recruiting Site
      • Tampa, Florida, United States, 33613
        • Recruiting
        • Central Recruiting Site
    • Illinois
      • Gurnee, Illinois, United States, 60031
        • Recruiting
        • Central Recruiting Site
    • Louisiana
      • Lake Charles, Louisiana, United States, 70605
        • Recruiting
        • Central Recruiting Site
    • Missouri
      • Fenton, Missouri, United States, 63026
        • Recruiting
        • Central Recruiting Site
    • Nevada
      • Las Vegas, Nevada, United States, 89109
        • Recruiting
        • Central Recruiting Site
    • New York
      • Garden City, New York, United States, 11530
        • Recruiting
        • Central Recruiting Site
      • Williamsville, New York, United States, 14221
        • Recruiting
        • Central Recruiting Site
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • Recruiting
        • Central Recruiting Site
    • Texas
      • Houston, Texas, United States, 77346
        • Recruiting
        • Central Recruiting Site
      • McAllen, Texas, United States, 78504
        • Recruiting
        • Central Recruiting Site
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Recruiting
        • Central Recruiting Site
    • Wisconsin
      • Madison, Wisconsin, United States, 53715
        • Recruiting
        • Central Recruiting Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo for Subcutaneous Injection
Experimental: Halneuron
Drug: Halneuron
Halneuron for Subcutaneous Injection
Active Comparator: Open Label Extension
Subjects may choose to continue in an Open Label Extension (OLE) phase if they complete the randomized phase. All subjects regardless of treatment assignment in the randomized phase will receive Halneuron, during the OLE phase of the study, if offered by the clinical site.
Drug: Halneuron
Halneuron for Subcutaneous Injection
Drug: Halneuron (Open Label Extension)
Halneuron for Subcutaneous Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NRS Pain
Time Frame: 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
From enrollment to end of study at 4 weeks
Safety Assessments
Time Frame: 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)
From enrollment to end of study at 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Global Impression of Change (PGIC)
Time Frame: Enrollment to end of study at week 4
Patient Global Impression of Change (PGIC)
Enrollment to end of study at week 4
PROMIS Fatigue
Time Frame: Enrollment to end of study at week 4
Change from baseline to week 4 on the PROMIS Fatigue instrument
Enrollment to end of study at week 4
PROMIS Sleep
Time Frame: Enrollment to end of study at week 4
Change from baseline to week 4 on PROMIS Sleep instrument
Enrollment to end of study at week 4
PROMIS-29 Quality of Life
Time Frame: Enrollment to end of study at week 4
Change from baseline to week 4 on the domains of the PROMIS-29 instrument
Enrollment to end of study at week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dogwood Therapeutics Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 21, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

February 3, 2025

First Submitted That Met QC Criteria

February 21, 2025

First Posted (Actual)

February 27, 2025

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 27, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HAL-CINP-203

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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