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Efficacy and Safety Study of Halneuron in the Treatment of Chemotherapy-Induced Neuropathic Pain
NCT06848348 · Dogwood Therapeutics Inc.
In plain English
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Official 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
About this study
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
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
Enrollment target: 240 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2025-02-21
Estimated completion: 2026-12
Last updated: 2026-09-16
Interventions
Drug: HalneuronDrug: PlaceboDrug: Halneuron (Open Label Extension)
Primary outcomes
- • NRS Pain (From enrollment to end of study at 4 weeks)
- • Safety Assessments (From enrollment to end of study at 4 weeks)
Sponsor
Dogwood Therapeutics Inc. · industry
All locations (25)
Central Recruiting Site
Sheffield, Alabama, United States
Central Recruiting Site
Glendale, Arizona, United States
Central Recruiting Site
Phoenix, Arizona, United States
Central Recruiting Site
Fair Oaks, California, United States
Central Recruiting Site
Fountain Valley, California, United States
Central Recruiting Site
Los Angeles, California, United States
Central Recruiting Site
Santa Rosa, California, United States
Central Recruiting Site
Wheat Ridge, Colorado, United States
Central Recruiting Site
Jacksonville, Florida, United States
Central Recruiting Site
Jacksonville, Florida, United States
Central Recruiting Site
Lakeland, Florida, United States
Central Recruiting Site
Orlando, Florida, United States
Central Recruiting Site
Port Charlotte, Florida, United States
Central Recruiting Site
Tampa, Florida, United States
Central Recruiting Site
Gurnee, Illinois, United States
Central Recruiting Site
Lake Charles, Louisiana, United States
Central Recruiting Site
Fenton, Missouri, United States
Central Recruiting Site
Las Vegas, Nevada, United States
Central Recruiting Site
Garden City, New York, United States
Central Recruiting Site
Williamsville, New York, United States
Central Recruiting Site
Winston-Salem, North Carolina, United States
Central Recruiting Site
Houston, Texas, United States
Central Recruiting Site
McAllen, Texas, United States
Central Recruiting Site
Salt Lake City, Utah, United States
Central Recruiting Site
Madison, Wisconsin, United States