Chemotherapy Induced Neuropathic Pain, Chemotherapy Induced Pain, Chemotherapy Induced Pain Neuropathy
Conditions
Keywords
Chemotherapy, Pain, Neuropathy, Cancer, CIPN, CINP, Chemotherapy Induced, Neuropathic Pain, Breast Cancer, Colorectal Cancer, Cancer Pain, Peripheral Neuropathy
Brief summary
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.
Interventions
DRUGHalneuron
Halneuron for Subcutaneous Injection
DRUGPlacebo
Placebo for Subcutaneous Injection
DRUGHalneuron (Open Label Extension)
Halneuron for Subcutaneous Injection
Sponsors
Dogwood Therapeutics Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NRS Pain | From enrollment to end of study at 4 weeks | Change from Baseline in the weekly average of daily 24-hour pain intensity scores analyzed by percentage of responders among patients treated with Halneuron compared to Placebo |
| Safety Assessments | From enrollment to end of study at 4 weeks | Incidence of serious adverse events (SAEs), adverse events (AEs) and Adverse Events of Special Interests (AESIs) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Global Impression of Change (PGIC) | Enrollment to end of study at week 4 | Patient Global Impression of Change (PGIC) |
| PROMIS Fatigue | Enrollment to end of study at week 4 | Change from baseline to week 4 on the PROMIS Fatigue instrument |
| PROMIS Sleep | Enrollment to end of study at week 4 | Change from baseline to week 4 on PROMIS Sleep instrument |
| PROMIS-29 Quality of Life | Enrollment to end of study at week 4 | Change from baseline to week 4 on the domains of the PROMIS-29 instrument |
Countries
United States
Outcome results
None listed