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NCT Number: NCT06848348

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.

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Key information

Conditions

Chemotherapy Induced Neuropathic Pain Breast Diseases Breast Neoplasms Cancer Pain Chemotherapy Induced Pain Chemotherapy Induced Pain Neuropathy Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Rectal Diseases Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Central Recruiting Site, Sheffield, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Halneuron

Drug

Halneuron for Subcutaneous Injection

Placebo

Drug

Placebo for Subcutaneous Injection

Halneuron (Open Label Extension)

Drug

Halneuron for Subcutaneous Injection

Primary outcomes

  1. 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

  2. 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)

Secondary outcomes

  1. Patient Global Impression of Change (PGIC)

    Time frame: Enrollment to end of study at week 4

    Patient Global Impression of Change (PGIC)

  2. PROMIS Fatigue

    Time frame: Enrollment to end of study at week 4

    Change from baseline to week 4 on the PROMIS Fatigue instrument

  3. PROMIS Sleep

    Time frame: Enrollment to end of study at week 4

    Change from baseline to week 4 on PROMIS Sleep instrument

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Dogwood Therapeutics

CONTACT

[email protected]

866-620-9255

Sponsors and collaborators

Lead sponsor

Dogwood Therapeutics Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 27, 2025
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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