Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06848348 | Efficacy and Safety Study of Halneuron in the Treatment of Chemotherapy-Induced Neuropathic Pain | PHASE2 | RECRUITING | 240 | — | — | Feb 21, 2025 | Aug 1, 2026 | May 29, 2026 | 25 | United States |
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
Incidence of serious adverse events (SAEs), adverse events (AEs) and Adverse Events of Special Interests (AESIs)
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Halneuron | EXPERIMENTAL | Halneuron |
| Open Label Extension | ACTIVE_COMPARATOR | Subjects may choose to continue in an Open Label Extension (OLE) phase if they complete the randomized phase. All subjects regardless of treatment assignment in the randomized phase will receive Halneuron, during the OLE phase of the study, if offered by the clinical site. |
| Name | Type | Description |
|---|---|---|
| Halneuron | DRUG | Halneuron for Subcutaneous Injection |
| Placebo | DRUG | Placebo for Subcutaneous Injection |
| Halneuron (Open Label Extension) | DRUG | Halneuron for Subcutaneous Injection |
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...