A Multi-center, Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of 400mg/Day Lacosamide in Subjects With Painful Distal Diabetic Neuropathy Using Two Different Titration Schemes
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 551
- 主要终点
- Change in Average Daily Pain Score From Baseline Week to the Last 4 Weeks of the Maintenance Phase
研究概览
简要总结
The purpose of this trial is to assess whether 400mg/day of lacosamide is effective in reducing pain caused by distal diabetic neuropathy. Two dose-escalation schemes for lacosamide will be used to further determine the efficacy of the "standard" scheme and to evaluate the efficacy and safety of a more rapid titration scheme. Subjects will be randomly assigned to one of three treatment groups. Subjects in two of the groups will receive lacosamide at a dose of 400mg/day, but different dose-escalation schemes will be used to reach this final dose. The third group of subjects will receive a placebo. Subjects will have a 2 in 3 (66 %) chance of getting lacosamide.
The maximum lacosamide dose in this trial will be 400mg/day. The maximum treatment duration will be 18 weeks, including a two-week Pre-Treatment Phase and a 12 weeks period on a stable dose of lacosamide or placebo.
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
- •Subject has had symptoms of painful diabetic neuropathy for at least 6 months and has a diagnosis of diabetes mellitus (Type I or Type II).
排除标准
- •Subject has previously participated in this trial or subject has previously been assigned to treatment in a trial of the drug under investigation in this trial
研究组 & 干预措施
Lacosamide Standard Titration (ST)
Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100 mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.
干预措施: SPM 929 (Drug)
Lacosamide Fast Titration (FT)
Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.
干预措施: SPM 929 (Drug)
Placebo
Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Average Daily Pain Score From Baseline Week to the Last 4 Weeks of the Maintenance Phase
时间窗: Last 4 weeks of Maintenance Phase, compared to the Baseline Week
An 11-point Likert scale is used to assess the subject's average daily pain. This scale is completed by the subject twice daily (once in the morning and once in the evening). The subject rates his/her average pain over the last 12 hours, from 0 (no pain) to 10 (worst pain ever experienced). The daily pain score is defined as the average score of those collected in the morning and evening. The value reported below is calculated as a difference between the average of the last available 28 days of maintenance for participants completing the maintenance phase (or the last 28 days prior to discontinuation for participants who discontinued in the titration or maintenance phase) and the average of the Baseline week.
次要结局
- Percentage of Subjects With >= 30% or >= 2-point Reduction of with-in Subject Change in Average Daily Pain Score From the Baseline Week to the Last 4 Weeks of the Maintenance Phase(Baseline week, last 4 weeks of the Maintenance Phase)
- Within-subject Change in Average Daily Pain Score From the Baseline Week to the Treatment Phase(Treatment Phase (16 weeks), compared to the Baseline Week)
- Within-subject Change From the Baseline Week to Visit 7 in Daily Perception of Pain Interference With Subject's Sleep(Baseline Week, Visit 7)
- Time to Sustainable Pain Relief(From start of trial medication intake (Week 0) up to the last 4 weeks of the Maintenance Phase)
- Within-subject Change in Average Daily Pain Score From the Baseline Week to Visit 3(Baseline week, Visit 3)
- Within-subject Change in Average Daily Pain Score From the Baseline Week to Visit 4(Baseline week, Visit 4)
- Within-subject Change in Average Daily Pain Score From the Baseline Week to Visit 7(Baseline week, Visit 7)
- Within-subject Change in Average Daily Pain Score From the Baseline Week to Visit 8(Baseline week, Visit 8)
- Within-subject Change in Average Daily Pain Score From the Baseline Week to the Titration Phase(Titration Phase (4 weeks), compared to the Baseline Week)
- Within-subject Change in Average Daily Pain Score From the Baseline Week to the Maintenance Phase(Maintenance Phase (12 weeks), compared to the Baseline Week)
- Within-subject Change in Average Daily Pain Score From the Baseline Week to Visit 5(Baseline week, Visit 5)
- Within-subject Change in Average Daily Pain Score From the Baseline Week to Visit 6(Baseline week, Visit 6)
- Within-subject Change From the Baseline Week to Visit 3 in Daily Perception of Pain Interference With Subject's Sleep(Baseline Week, Visit 3)
- Within-subject Change in Average Daily Pain Score From the Baseline Week to the Last 4 Weeks of Maintenance Phase(Last 4 weeks of Maintenance Phase, compared to the Baseline Week)
- Within-subject Change From the Baseline Week to Visit 6 in Daily Perception of Pain Interference With Subject's Sleep(Baseline Week, Visit 6)
- Within-subject Change From the Baseline Week to Visit 4 in Daily Perception of Pain Interference With Subject's Sleep(Baseline Week, Visit 4)
- Within-subject Change From the Baseline Week to Visit 5 in Daily Perception of Pain Interference With Subject's Sleep(Baseline Week, Visit 5)
- Within-subject Change From the Baseline Week to Visit 8 in Daily Perception of Pain Interference With Subject's Sleep(Baseline Week, Visit 8)
- Within-subject Change From the Baseline Week to the Titration Phase in Daily Perception of Pain Interference With Subject's Sleep(Titration Phase (4 weeks), compared to the Baseline Week)
- Within-subject Change From the Baseline Week to the Last 4 Weeks of Maintenance Phase in Daily Perception of Pain Interference With Subject's Sleep(Last 4 weeks of Maintenance Phase, compared to the Baseline Week)
- Within-subject Change From the Baseline Week to Visit 5 in Daily Perception of Pain Interference With Subject's General Activity(Baseline Week, Visit 5)
- Within-subject Change From the Baseline Week to Visit 6 in Daily Perception of Pain Interference With Subject's General Activity(Baseline Week, Visit 6)
- Within-subject Change From the Baseline Week to the Maintenance Phase in Daily Perception of Pain Interference With Subject's Sleep(Maintenance Phase (12 weeks), compared to the Baseline Week)
- Within-subject Change From the Baseline Week to the Treatment Phase in Daily Perception of Pain Interference With Subject's Sleep(Treatment Phase (16 weeks), compared to the Baseline Week)
- Within-subject Change From the Baseline Week to Visit 3 in Daily Perception of Pain Interference With Subject's General Activity(Baseline Week, Visit 3)
- Within-subject Change From the Baseline Week to Visit 4 in Daily Perception of Pain Interference With Subject's General Activity(Baseline Week, Visit 4)
- Within-subject Change From the Baseline Week to Visit 7 in Daily Perception of Pain Interference With Subject's General Activity(Baseline Week, Visit 7)
- Within-subject Change From Baseline to Visit 8 in Subject's Quality of Life(Baseline, Visit 8)
- Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 8(Visit 8)
- Percentage of Patients With Categorized Satisfaction With Medications at Visit 8(Visit 8)
- Within-subject Change From the Baseline Week to Visit 8 in Daily Perception of Pain Interference With Subject's General Activity(Baseline Week, Visit 8)
- Within-subject Change From the Baseline Week to the Last 4 Weeks of the Maintenance Phase in Daily Perception of Pain Interference With Subject's General Activity(Last 4 weeks of Maintenance Phase, compared to the Baseline Week)
- Percentage of Days of Rescue Medication Use During the Treatment Phase(During the Treatment Phase (up to 16 weeks))
- Within-subject Change From the Baseline Week to the Titration Phase in Daily Perception of Pain Interference With Subject's General Activity(Titration Phase (4 weeks), compared to the Baseline Week)
- Within-subject Change From the Baseline Week to the Maintenance Phase in Daily Perception of Pain Interference With Subject's General Activity(Maintenance Phase (12 weeks), compared to the Baseline Week)
- Within-subject Change From the Baseline Week to the Treatment Phase in Daily Perception of Pain Interference With Subject's General Activity(Treatment Phase (16 weeks), compared to the Baseline Week)
- Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale Scores at Visit 8(Baseline, Visit 8)