Efficacy and Safety Study of Halneuron in the Treatment of Chemotherapy-Induced Neuropathic Pain
Recruiting · NCT06848348 · Interventional (participants receive a specific treatment) · Lead sponsor: Dogwood Therapeutics Inc.
View the official record on ClinicalTrials.gov →Interventions studied
HalneuronHalneuron (Open Label Extension)Placebo
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
25 locations listed across 14 US states.
- 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