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
APEX Research Group, LLC
Fair Oaks, California 95628
Fair Oaks, California 95628
Ark Clinical Research
Fountain Valley, California 92708
Fountain Valley, California 92708
Profound Research LLC
Pasadena, California 91105
Pasadena, California 91105
Providence Medical Foundation
Santa Rosa, California 95403
Santa Rosa, California 95403
Paradigm Clinical Research
Wheat Ridge, Colorado 80033
Wheat Ridge, Colorado 80033
TOI Clinical Research
Lakeland, Florida 33812
Lakeland, Florida 33812
Conquest Research LLC
Orlando, Florida 32832
Orlando, Florida 32832
Medsol Clinical Research Center, Inc
Port Charlotte, Florida 33952
Port Charlotte, Florida 33952
CenExel FCR
Tampa, Florida 33613
Tampa, Florida 33613
CenExel ACMR
Atlanta, Georgia 30331
Atlanta, Georgia 30331
Profound Research at OMG Division of Clinical Hematology and Medical Oncology
Farmington, Michigan 48334
Farmington, Michigan 48334
Circuit Clinical/ SSM St. Clare Cancer Care
Fenton, Missouri 63026
Fenton, Missouri 63026
Saint Lukes Hospital
Kansas City, Missouri 64111
Kansas City, Missouri 64111
Exel Clinical Research
Las Vegas, Nevada 89109
Las Vegas, Nevada 89109
Rubin MD
Garden City, New York 11530
Garden City, New York 11530
Upstate Clinical Research Associates LLC
Williamsville, New York 14221
Williamsville, New York 14221
Center for Oncology and Blood Disorders
Houston, Texas 77030
Houston, Texas 77030
CenExel JBR
Salt Lake City, Utah 84107
Salt Lake City, Utah 84107
SSM Health Dean Medical Group
Madison, Wisconsin 53715
Madison, Wisconsin 53715
More Details
- NCT ID
- NCT06848348
- Status
- Recruiting
- Sponsor
- Dogwood Therapeutics Inc.