A Multi-Center, Open-Label, Follow-On Trial to Assess the Long Term Safety and Efficacy of SPM 927 in Subjects With Painful Distal Diabetic Neuropathy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 451
- 主要终点
- Number of Subjects With Adverse Events (AEs) Reported Spontaneously by the Subject or Observed by the Investigator.
研究概览
简要总结
Phase 2/3 open-label trial to assess the safety and tolerability of long-term treatment with lacosamide (SPM 927) in subjects with painful diabetic neuropathy. The safety and tolerability of the different doses of lacosamide will be investigated.
详细描述
This phase 2/3 open-label trial is being conducted at approximately 100 sites in the US to assess the safety and tolerability of long-term treatment with lacosamide (SPM 927) in subjects with painful diabetic neuropathy. Approximately 525 subjects will be enrolled. To qualify for this trial, subjects with symptoms of painful distal diabetic neuropathy ranging in duration from 6 months to 5 years must have completed trials SP665, SP742, or SP768 and, in the investigator's opinion, may benefit from long-term administration of lacosamide. Subjects will be titrated to their optimal dose of lacosamide (up to 600mg/day). The safety and tolerability of the different doses of lacosamide will be investigated throughout the trial. In addition, to determine what effect lacosamide has on diabetic neuropathic pain, subjects will use a diary to record their daily pain intensity and pain interference with sleep and activity. Subjects' quality of life will also be investigated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 32 Years 至 81 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who completed Study SP665, SP742, or SP768 and, in the investigators opinion, might benefit from long-term administration of SPM
- •Exception: subjects who prematurely discontinued Study SP742 or SP768 due to lack of efficacy or due to intolerability to trial medication may be eligible to participate in Study SP745, after consultation with the medical monitor.
排除标准
- •Subject has clinically relevant electrocardiogram (ECG) abnormalities, or QT-corrected (QTc) interval >=500 milliseconds (ms), and/or a QTc interval increase of >=60ms from the mean pre-dose QTc value at Visit 2 of Studies SP665, SP742 or SP
- •Subject has aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >=3 times the upper limit of the normal range (ULN) with total bilirubin >=2 times ULN or transaminases (AST and/or ALT) >=5 times ULN.
- •Subject has a clinically relevant medical condition that, in the opinion of the investigator, jeopardizes or compromises the subject's ability to participate in this trial.
研究组 & 干预措施
1
Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
干预措施: lacosamide (Drug)
结局指标
主要结局
Number of Subjects With Adverse Events (AEs) Reported Spontaneously by the Subject or Observed by the Investigator.
时间窗: Throughout the study up to a maximum study period of 2.8 years
Number of subjects with adverse events (AEs) reported spontaneously by the subject or observed by the investigator (serious and non-serious).
次要结局
- Change From Baseline in Average Daily Pain Score Using an 11-point Likert Scale (0-10).(Baseline to end of entire treatment phase (maximum study period of 2.8 years).)
- Change From Baseline in Quality of Life Using the SF-36 Health Survey - Physical Component Summary (PCS)(Baseline to Termination Visit)
- Change From Baseline in Quality of Life Using the SF-36 Health Survey - Mental Component Summary (MCS)(Baseline to Termination Visit)
- Change From Baseline in Average Pain Score as Measured by a 100mm Visual Analogue Scale (VAS).(Baseline to end of entire treatment phase (maximum study period of 2.8 years).)
- Patient's Global Impression of Change (PGIC) From Baseline in Pain.(Baseline to Termination Visit)
- Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Intensity.(Baseline to Termination Visit)
- Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Sharpness(Baseline to Termination Visit)
- Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Heat(Baseline to Termination Visit)
- Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Dullness(Baseline to Termination Visit)
- Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Cold(Baseline to Termination Visit)
- Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Sensitivity(Baseline to Termination Visit)
- Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Itchiness(Baseline to Termination Visit)
- Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Unpleasantness(Baseline to Termination Visit)
- Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Deep Pain(Baseline to Termination Visit)
- Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Surface Pain(Baseline to Termination Visit)
- Change From Baseline in Average Pain Interference With Sleep (11-point Likert Scale)(Baseline to end of entire treatment phase visit)
- Change From Baseline in Average Pain Interference With Activity (11-point Likert Scale)(Baseline to end of entire treatment phase visit)