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.
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.
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.
Parallel
Halneuron
DrugHalneuron for Subcutaneous Injection
Placebo
DrugPlacebo for Subcutaneous Injection
Halneuron (Open Label Extension)
DrugHalneuron for Subcutaneous Injection
NRS Pain
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
Incidence of serious adverse events (SAEs), adverse events (AEs) and Adverse Events of Special Interests (AESIs)
Patient Global Impression of Change (PGIC)
Patient Global Impression of Change (PGIC)
PROMIS Fatigue
Change from baseline to week 4 on the PROMIS Fatigue instrument
PROMIS Sleep
Change from baseline to week 4 on PROMIS Sleep instrument
PROMIS-29 Quality of Life
Change from baseline to week 4 on the domains of the PROMIS-29 instrument
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