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
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 240
- 试验地点
- 50
- 主要终点
- To explore the efficacy of Halneuron in the treatment of patients with Chemotherapy-Induced Neuropathic Pain
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Halneuron
Halneuron
干预措施: Halneuron (Drug)
Open Label Extension
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.
干预措施: Halneuron (Open Label Extension) (Drug)
Open Label Extension
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.
干预措施: Halneuron (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
To explore the efficacy of Halneuron in the treatment of patients with Chemotherapy-Induced Neuropathic Pain
时间窗: 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
To explore the Safety of Halneuron in the treatment of patients with Chemotherapy-Induced Neuropathic Pain
时间窗: 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)
次要结局
- Responder analyses for patient global impression of change (PGIC)(Enrollment to end of study at week 4)
- Determine benefits of Halneuron treatment on non-pain outcomes including sleep quality, fatigue and mood(Enrollment to end of study at week 4)