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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Placebo Comparator Placebo |
Placebo |
|
|
Experimental Halneuron |
Halneuron |
|
Recruiting Locations
Sheffield 4089536, Alabama 4829764 35660
Glendale 5295985, Arizona 5551752 85308
Fair Oaks 5347287, California 5332921 95628
Fountain Valley 5350207, California 5332921 92708
Los Angeles 5368361, California 5332921 91307
Santa Rosa 5393287, California 5332921 95403
Wheat Ridge 5443948, Colorado 5417618 80033
Jacksonville 4160021, Florida 4155751 32205
Jacksonville 4160021, Florida 4155751 32256
Lakeland 4161438, Florida 4155751 33812
Orlando 4167147, Florida 4155751 32832
Port Charlotte 4169130, Florida 4155751 33952
Tampa 4174757, Florida 4155751 33613
Atlanta 4180439, Georgia 4197000 30331
Gurnee 4894861, Illinois 4896861 60031
Farmington 4992519, Michigan 5001836 48334
Fenton 4386381, Missouri 4398678 63026
Kansas City 4393217, Missouri 4398678 64111
Las Vegas 5506956, Nevada 5509151 89109
Garden City 5118226, New York 5128638 11530
Williamsville 5144588, New York 5128638 14221
Winston-Salem 4499612, North Carolina 4482348 27103
Salt Lake City 5780993, Utah 5549030 84107
Madison 5261457, Wisconsin 5279468 53715
More Details
- NCT ID
- NCT06848348
- Status
- Recruiting
- Sponsor
- Dogwood Therapeutics Inc.