Treatment of neuropathic pain caused by chemotherapy with Halneuron
A Randomized, Double-Blind, Placebo Controlled, Multicenter, Efficacy and Safety Study of Halneuron in the Treatment of Chemotherapy-Induced Neuropathic Pain
This study is testing if a single injection of Halneuron can help relieve neuropathic pain caused by chemotherapy in patients who have experienced this type of pain.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Dogwood Therapeutics Inc. Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 24 sites (Sheffield, Alabama and 23 other locations) |
| Trial ID | NCT06848348 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of a single subcutaneous administration of Halneuron in patients suffering from chemotherapy-induced neuropathic pain (CINP). It is a randomized, interventional Phase 2 trial that aims to determine how well Halneuron alleviates pain compared to a placebo. Participants must have a history of neuropathic pain linked to specific chemotherapy agents, namely platinum and/or taxanes, and must not have active disease progression. The study will help assess whether Halneuron can provide relief for patients experiencing this type of pain.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have neuropathic pain attributed to platinum or taxane chemotherapy.
Not a fit: Patients with neuropathic pain from causes other than platinum or taxane chemotherapy will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce neuropathic pain for patients undergoing chemotherapy.
How similar studies have performed: While this approach is being tested in this specific context, similar studies have shown promise in treating neuropathic pain with other interventions.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Sheffield, Alabama and 23 other locations
- Central Recruiting Site — Sheffield, Alabama, United States (Recruiting)
- Central Recruiting Site — Glendale, Arizona, United States (Recruiting)
- Central Recruiting Site — Fair Oaks, California, United States (Recruiting)
- Central Recruiting Site — Fountain Valley, California, United States (Recruiting)
- Central Recruiting Site — Los Angeles, California, United States (Recruiting)
- Central Recruiting Site — Santa Rosa, California, United States (Recruiting)
- Central Recruiting Site — Wheat Ridge, Colorado, United States (Recruiting)
- Central Recruiting Site — Jacksonville, Florida, United States (Recruiting)
- Central Recruiting Site — Jacksonville, Florida, United States (Recruiting)
- Central Recruiting Site — Lakeland, Florida, United States (Recruiting)
- Central Recruiting Site — Orlando, Florida, United States (Recruiting)
- Central Recruiting Site — Port Charlotte, Florida, United States (Recruiting)
- Central Recruiting Site — Tampa, Florida, United States (Recruiting)
- Central Recruiting Site — Atlanta, Georgia, United States (Recruiting)
- Central Recruiting Site — Gurnee, Illinois, United States (Recruiting)
- Central Recruiting Site — Farmington, Michigan, United States (Recruiting)
- Central Recruiting Site — Fenton, Missouri, United States (Recruiting)
- Central Recruiting Site — Kansas City, Missouri, United States (Recruiting)
- Central Recruiting Site — Las Vegas, Nevada, United States (Recruiting)
- Central Recruiting Site — Garden City, New York, United States (Recruiting)
- Central Recruiting Site — Williamsville, New York, United States (Recruiting)
- Central Recruiting Site — Winston-Salem, North Carolina, United States (Recruiting)
- Central Recruiting Site — Salt Lake City, Utah, United States (Recruiting)
- Central Recruiting Site — Madison, Wisconsin, United States (Recruiting)
Study contacts
- Study coordinator: Dogwood Therapeutics
- Email: Mehran@dwtx.com
- Phone: 866-620-9255
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.