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

NCT ID: NCT06848348

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-21

Study Completion Date

2026-08-31

Brief Summary

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A randomized study to determine safety and efficacy of single subcutaneous (SC) administration of HAL treatment in patients with CINP.

Detailed Description

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Conditions

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Chemotherapy Induced Neuropathic Pain

Keywords

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Neuropathic Pain Chemotherapy Pain Neuropathy Cancer CIPN CINP

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo for Subcutaneous Injection

Halneuron

Halneuron

Group Type EXPERIMENTAL

Halneuron

Intervention Type DRUG

Halneuron for Subcutaneous Injection

Interventions

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Halneuron

Halneuron for Subcutaneous Injection

Intervention Type DRUG

Placebo

Placebo for Subcutaneous Injection

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dogwood Therapeutics Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Central Recruiting Site

Sheffield, Alabama, United States

Site Status RECRUITING

Central Recruiting Site

Glendale, Arizona, United States

Site Status RECRUITING

Central Recruiting Site

Fair Oaks, California, United States

Site Status RECRUITING

Central Recruiting Site

Fountain Valley, California, United States

Site Status RECRUITING

Central Recruiting Site

Los Angeles, California, United States

Site Status RECRUITING

Central Recruiting Site

Santa Rosa, California, United States

Site Status RECRUITING

Central Recruiting Site

Wheat Ridge, Colorado, United States

Site Status RECRUITING

Central Recruiting Site

Jacksonville, Florida, United States

Site Status RECRUITING

Central Recruiting Site

Jacksonville, Florida, United States

Site Status RECRUITING

Central Recruiting Site

Lakeland, Florida, United States

Site Status RECRUITING

Central Recruiting Site

Orlando, Florida, United States

Site Status RECRUITING

Central Recruiting Site

Port Charlotte, Florida, United States

Site Status RECRUITING

Central Recruiting Site

Tampa, Florida, United States

Site Status RECRUITING

Central Recruiting Site

Atlanta, Georgia, United States

Site Status RECRUITING

Central Recruiting Site

Gurnee, Illinois, United States

Site Status RECRUITING

Central Recruiting Site

Farmington, Michigan, United States

Site Status RECRUITING

Central Recruiting Site

Fenton, Missouri, United States

Site Status RECRUITING

Central Recruiting Site

Kansas City, Missouri, United States

Site Status RECRUITING

Central Recruiting Site

Las Vegas, Nevada, United States

Site Status RECRUITING

Central Recruiting Site

Garden City, New York, United States

Site Status RECRUITING

Central Recruiting Site

Williamsville, New York, United States

Site Status RECRUITING

Central Recruiting Site

Winston-Salem, North Carolina, United States

Site Status RECRUITING

Central Recruiting Site

Salt Lake City, Utah, United States

Site Status RECRUITING

Central Recruiting Site

Madison, Wisconsin, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Dogwood Therapeutics

Role: CONTACT

Phone: 866-620-9255

Email: [email protected]

Other Identifiers

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HAL-CINP-203

Identifier Type: -

Identifier Source: org_study_id