A Phase IIa Study of the Efficacy and Safety of Oral LAT8881 in Neuropathic Pain
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 6
- 主要终点
- Absolute Change in Mean Pain Score, Using an 11 Point Numeric Pain Rating Scale (NPRS)
研究概览
简要总结
This is a randomised, placebo-controlled, double-blind, crossover, phase IIa study to investigate the efficacy and safety of oral LAT8881 in neuropathic pain.
详细描述
This is a randomised, placebo-controlled, double-blind, crossover, phase IIa study to investigate the efficacy and safety of oral LAT8881 in neuropathic pain. After a one week baseline period, subjects entered into the study will be randomised to receive Investigational Medicinal Product (IMP) (LAT8881 or placebo) twice daily for four weeks.
The first treatment period will be followed by a washout period of two weeks and then a second baseline period of one week. Subjects will not take any IMP over these three weeks.
After the second baseline period, subjects will cross over to receive the second treatment (either LAT8881 or placebo, whichever treatment was not received in the first treatment period) twice daily for four weeks.
The pharmacokinetics (PK) of LAT8881 will be investigated in 15 subjects (PK subjects) at selected Australian sites.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of post herpetic neuralgia, with pain persisting for at least 3 months after the onset of herpes zoster rash OR
- •Clinical diagnosis of distal painful polyneuropathy due to Type I or Type II diabetes mellitus with:
- •symmetrical, bilateral pain in the lower extremities for at least 3 months and
- •diabetes under control for at least 3 months prior to randomisation, as indicated by a glycated haemoglobin level (HbA1c) of ≤ 11% (97 mmol/mol) and on a stable dose of insulin or oral diabetic medication for 3 months prior to screening, and
- •no change in diabetic medication planned for the duration of the study
- •Positive sensory symptoms (mechanical or thermal) associated with neuropathic pain, confirmed by:
- •painDETECT questionnaire (PD-Q) and
- •Clinical assessment, showing signs of neuropathic pain in either a dermatomal (PHN) or distal symmetrical distribution (DPN)
- •An average daily pain score on the numeric pain rating scale (NPRS) of at least 4 and no more than 8 in the last five diary entries before randomisation
排除标准
- •Presence of moderate to severe pain from other causes that may confound assessment or self-evaluation of NP.
- •Subjects with both DPN and PHN
研究组 & 干预措施
Placebo
1 x 30 mg capsule of placebo, taken by mouth, twice daily (morning and evening) during the four-week treatment period.
干预措施: Placebo (Drug)
LAT8881
1 x 30 mg capsule of LAT8881 taken by mouth, twice daily (morning and evening) during the four-week treatment period.
干预措施: LAT8881 (Drug)
结局指标
主要结局
Absolute Change in Mean Pain Score, Using an 11 Point Numeric Pain Rating Scale (NPRS)
时间窗: Baseline to Week 4
The 11-point numeric pain rating scale (NPRS) ranges from 0 ("no pain") to 10 ("worst pain imaginable"). A larger negative number represents a greater reduction in pain. The efficacy of oral LAT8881 in neuropathic pain was compared with placebo, when assessed by change in mean pain intensity scores, using this 11 point numeric pain rating scale.
次要结局
- Change in NPRS Score After the First and Last Dose of LAT8881 and Placebo(Pre-dose, 0.5,1,2,4 and 6 hours after the first and last dose of LAT8881 and placebo)
- Change in Mean Pain Scores After 1, 2 and 3 Weeks of Treatment, Using NPRS(1,2 and 3 weeks)
- Change in Pain Characteristics and Intensity, as Assessed by the Short Form McGill Pain Questionnaire (SF-MPQ-2)(4 weeks)
- 30% Responder Rate in Oral LAT8881 Compared With Placebo, as Assessed by the Numeric Pain Rating Scale.(4 weeks)
- Change in Neuropathic Pain Symptoms, as Assessed by Neuropathic Pain Symptom Inventory (NPSI)(4 weeks)
- Change in Emotional Functioning, as Assessed by the Beck Depression Inventory-II(4 weeks)
- Patient Global Impression of Change Score(4 weeks)
- Rescue Medication Use(Weekly over four-week treatment)
- Time to Maximum Plasma Concentration of LAT8881 (Tmax)(Day 1 and day 28)
- 50% Responder Rate in Oral LAT8881 Compared With Placebo, as Assessed by the Numeric Pain Rating Scale.(4 weeks)
- Maximum Change in Mean NPRS(1,2,3 or 4 weeks)
- Area Under the Concentration Time Curve From Zero to Infinity (AUC0-inf)(Day 1 and Day 28)
- Change in Functioning as Assessed by the Brief Pain Inventory Interference Scale (BPI)(4 weeks)
- Maximum Plasma Concentration of LAT8881 (Cmax) After Oral LAT8881(Day 1 and Day 28)