Efficacy and Safety Study of Halneuron in the Treatment of Chemotherapy-Induced Neuropathic Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Halneuron, Placebo, Halneuron (Open Label Extension).
- Who it may be relevant to
- Registry conditions: Chemotherapy Induced Neuropathic Pain, Chemotherapy Induced Pain Neuropathy, Chemotherapy Induced Pain. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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
- Drug Halneuron
Halneuron for Subcutaneous Injection - Drug Placebo
Placebo for Subcutaneous Injection - Drug Halneuron (Open Label Extension)
Halneuron for Subcutaneous Injection
Primary outcome measures
- NRS Pain [Time frame: From enrollment to end of study at 4 weeks]
- Safety Assessments [Time frame: From enrollment to end of study at 4 weeks]
Secondary outcome measures (4)
- Patient Global Impression of Change (PGIC) [Time frame: Enrollment to end of study at week 4]
- PROMIS Fatigue [Time frame: Enrollment to end of study at week 4]
- PROMIS Sleep [Time frame: Enrollment to end of study at week 4]
- PROMIS-29 Quality of Life [Time frame: Enrollment to end of study at week 4]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 25 centers
- Central Recruiting Site — Sheffield
- Central Recruiting Site — Glendale
- Central Recruiting Site — Phoenix
- Central Recruiting Site — Fair Oaks
- Central Recruiting Site — Fountain Valley
- Central Recruiting Site — Los Angeles
- Central Recruiting Site — Santa Rosa
- Central Recruiting Site — Wheat Ridge
- … and 17 more centers
Identifiers
NCT: NCT06848348 · HAL-CINP-203