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

Purpose

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

Condition

  • Chemotherapy Induced Neuropathic Pain

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
Placebo 		Placebo
  • Drug: Placebo
    Placebo for Subcutaneous Injection
Experimental
Halneuron 		Halneuron
  • Drug: Halneuron
    Halneuron for Subcutaneous Injection

Recruiting Locations

Central Recruiting Site
Sheffield 4089536, Alabama 4829764 35660

Central Recruiting Site
Glendale 5295985, Arizona 5551752 85308

Central Recruiting Site
Fair Oaks 5347287, California 5332921 95628

Central Recruiting Site
Fountain Valley 5350207, California 5332921 92708

Central Recruiting Site
Los Angeles 5368361, California 5332921 91307

Central Recruiting Site
Santa Rosa 5393287, California 5332921 95403

Central Recruiting Site
Wheat Ridge 5443948, Colorado 5417618 80033

Central Recruiting Site
Jacksonville 4160021, Florida 4155751 32205

Central Recruiting Site
Jacksonville 4160021, Florida 4155751 32256

Central Recruiting Site
Lakeland 4161438, Florida 4155751 33812

Central Recruiting Site
Orlando 4167147, Florida 4155751 32832

Central Recruiting Site
Port Charlotte 4169130, Florida 4155751 33952

Central Recruiting Site
Tampa 4174757, Florida 4155751 33613

Central Recruiting Site
Atlanta 4180439, Georgia 4197000 30331

Central Recruiting Site
Gurnee 4894861, Illinois 4896861 60031

Central Recruiting Site
Farmington 4992519, Michigan 5001836 48334

Central Recruiting Site
Fenton 4386381, Missouri 4398678 63026

Central Recruiting Site
Kansas City 4393217, Missouri 4398678 64111

Central Recruiting Site
Las Vegas 5506956, Nevada 5509151 89109

Central Recruiting Site
Garden City 5118226, New York 5128638 11530

Central Recruiting Site
Williamsville 5144588, New York 5128638 14221

Central Recruiting Site
Winston-Salem 4499612, North Carolina 4482348 27103

Central Recruiting Site
Salt Lake City 5780993, Utah 5549030 84107

Central Recruiting Site
Madison 5261457, Wisconsin 5279468 53715

More Details

NCT ID
NCT06848348
Status
Recruiting
Sponsor
Dogwood Therapeutics Inc.

Study Contact

Dogwood Therapeutics
866-620-9255
Mehran@dwtx.com

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center