Phase 2a, Exploratory, Double-blind, Placebo-controlled Two-part Study to Evaluate the Safety, Efficacy, Tolerability and Pharmacokinetics of Topically Applied XPF-002 (XEN402 8% w/w Ointment) in Patients With Primary/Inherited Erythromelalgia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Average Daily Use of Cooling for Erythromelalgia-Related Pain in Treatment Period 2
研究概览
简要总结
This is a Phase 2a single-center, randomized, double-blind, Placebo-controlled, parallel group study with XPF-002 applied twice daily over 14 or 21 days in patients with Primary/Inherited Erythromelalgia (IEM). The purpose of this study is to determine whether XPF-002 is safe and effective in the treatment of pain caused by IEM.
详细描述
Your role in the study would include:
- Travelling to the clinic (in Anniston, Alabama, USA) for 3 out-patient visits, each lasting approximately 1 day
- Travelling and staying in the clinic for 2 in-patient stays:
- For the first in-patient visit you will have to spend 8 days and 7 nights in the clinic
- For the second in-patient visit you will have to spend 2 days and 1 night in the clinic You can bring books, laptops and DVDs to the clinic.
If you do not live within driving distance to the clinic you will need to stay in the local area (in Anniston, at a local hotel) for 1 to 2 weeks while you use the ointment, in addition to the in-patient portion of the study.
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
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have a Body Mass Index (BMI) of 18-40 kg/m2 (inclusive)
- •Have primary or inherited erythromelalgia (IEM)
- •Experience flares of pain in your feet or hands caused by erythromelalgia
- •Be generally healthy (apart from your pain)
- •Stop taking your usual pain medications and certain other medications for up to 11.5 weeks
- •Not be pregnant or breast-feeding
- •Must be able and willing to provide informed consent and willing to comply with all study procedures and restrictions
排除标准
- •Must not be in constant pain (must not continually be in moderate pain, 3/10 or more)
- •Coexistent source of pain from other conditions that may interfere with the study interpretation
- •HIV, Hepatitis B or C
- •Treatment for significant depression within 6 months of Screening
- •Not willing to use adequate contraception
- •Alcoholism, alcohol or substance abuse
- •Presence or history of major psychiatric disturbance
- •Any other condition or finding that may pose undue risk for participation
- •Use of any other investigational drug in the 30 days prior to dosing
- •Donation or loss of whole blood or plasma prior to dosing as follows: 50 mL to 499 mL within 30 days, or more than 499 mL within 56 days
- •Employee or relative of an employee who is directly involved in the study
研究组 & 干预措施
XPF-002
XEN402 8% w/w ointment for topical application, applied to the skin twice daily for 14 or 21 days
干预措施: XPF-002 (Drug)
Placebo
XEN402 0% w/w ointment for topical application. Identical content and appearance to the XPF-002 ointment but without the active medicine. Applied to the skin twice daily for 14 or 21 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Average Daily Use of Cooling for Erythromelalgia-Related Pain in Treatment Period 2
时间窗: 14-21 Days
Using diary cards, subjects recorded the use of all non-pharmacological cooling methods used to relieve their erythromelalgia (EM) pain each day during Treatment Period 2. A smaller average number of cooling uses each day in Treatment Period 2 indicates that subjects were in less pain/required less use of cooling to relieve their EM pain and vice versa.
次要结局
未报告次要终点