Clinical trial · Interventional
Efficacy and Safety Study of Halneuron in the Treatment of Chemotherapy-Induced Neuropathic Pain
A Randomized, Double-Blind, Placebo Controlled, Multicenter Study With Optional Open-Label Extension to Evaluate the Efficacy and Safety Study of Halneuron in the Treatment of Chemotherapy-Induced Neuropathic Pain
NCT06848348CI-TRIAL-00112892active not recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 17, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260917-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy Induced Neuropathic Pain | — | UNRESOLVED | — |
| Chemotherapy Induced Pain | — | UNRESOLVED | — |
| Chemotherapy Induced Pain Neuropathy | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Halneuron | Drug | — | UNRESOLVED |
| Halneuron (Open Label Extension) | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo
- interventionNames
- Drug: Placebo
- type
- EXPERIMENTAL
- label
- Halneuron
- description
- Halneuron
- interventionNames
- Drug: Halneuron
- type
- ACTIVE_COMPARATOR
- label
- Open Label Extension
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.