A Multi-center, Open-label, follow-on Trial to Assess the Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Distal Diabetic Neuropathy Including a Double-blind, Randomized Time Point Withdrawal Subtrial.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 621
- 试验地点
- 101
- 主要终点
- Number of Participants Experiencing the Occurrence of at Least One Treatment-emergent Adverse Event (TEAE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (Approximately 6.5 Years).
研究概览
简要总结
SP746 (NCT00546351) is a multi-center, open-label, follow-on trial. The purpose of this trial is to assess safety and tolerability of long-term exposure of lacosamide (previously referred to as SPM 927) in subjects with painful distal diabetic neuropathy.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who completed Study SP743 (NCT00238524) or SP874 (NCT00350103) and, in the investigator's opinion, might benefit from long-term administration of SP746 (NCT00546351). Exception: subjects who prematurely discontinued
- •SP743 (NCT00238524) or SP874 (NCT00350103) due to lack of efficacy or due to intolerability to trial medication (after Visit 5but prior to entering the Maintenance Phase) may be eligible to participate in SP746 (NCT00546351), after consultation with the medical monitor
排除标准
- •Subject has clinically relevant ECG abnormalities, or a QTc interval ≥500 ms, and/or a QTc interval increase of ≥60 ms from the mean pre-dose QTc value at Visit 2 of SP743 (NCT00238524) or SP874 (NCT00350103)
- •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
- •Subject is a pregnant or nursing female, or is of childbearing potential and is not surgically sterile, 2 years postmenopausal, or does not practice 2 combined methods of contraception
研究组 & 干预措施
Lacosamide
50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
干预措施: Lacosamide (Drug)
结局指标
主要结局
Number of Participants Experiencing the Occurrence of at Least One Treatment-emergent Adverse Event (TEAE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (Approximately 6.5 Years).
时间窗: From entry Visit 1 through end of treatment (approximately 6.5 years)
Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Number of Participants Experiencing the Occurrence of at Least One Serious Adverse Event (SAE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (Approximately 6.5 Years).
时间窗: From entry Visit 1 through end of treatment (approximately 6.5 years)
A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: * Is fatal * Is life-threatening * Results in persistent or significant disability/incapacity * Requires inpatient hospitalization * Prolongs existing inpatient hospitalization * Is a congenital anomaly/birth defect * Is considered to be an important medical event. Such an event may not be immediately life threatening or result in death or hospitalization but may jeopardize the subject or may require intervention to prevent one of the other outcomes listed in the definitions above
次要结局
- Average Daily Pain Score Using an 11-point Likert Scale (0-10) at Baseline Visit.(Baseline)
- Average Pain Score as Measured by a 100 mm Visual Analogue Scale (VAS) at Last Visit.(Last Visit (approximately 2 years))
- Patient's Global Impression of Change (PGIC) at Last Visit.(Last Visit (approximately 2 years))
- Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Intensity at Last Visit.(Baseline Visit; Last Visit (approximately 2 years))
- Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Cold at Last Visit.(Baseline Visit; Last Visit (approximately 2 years))
- Average Daily Pain Score Using an 11-point Likert Scale (0-10) at Last Visit.(Last Visit (approximately 2 years))
- Average Pain Score as Measured by a 100 mm Visual Analog Scale (VAS) at Baseline.(Baseline)
- Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Dullness at Last Visit.(Baseline Visit; Last Visit (approximately 2 years))
- Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Sharpness at Last Visit.(Baseline Visit; Last Visit (approximately 2 years))
- Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Heat at Last Visit.(Baseline Visit; Last Visit (approximately 2 years))
- Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Unpleasantness at Final Visit.(Baseline Visit; Last Visit (approximately 2 years))
- Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Surface Pain at Last Visit.(Baseline Visit; Last Visit (approximately 2 years))
- Average Pain Interference With Sleep (11-point Likert Scale) at Last Visit.(Last Visit)
- Average Pain Interference With Activity (11-point Likert Scale) at Baseline.(Baseline)
- Average Pain Interference With Activity (11-point Likert Scale) at Last Visit.(Last Visit)
- Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Deep Pain at Last Visit.(Baseline Visit; Last Visit (approximately 2 years))
- Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Itchiness at Final Visit.(Baseline Visit; Last Visit (approximately 2 years))
- Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Sensitivity at Last Visit.(Baseline Visit; Last Visit (approximately 2 years))
- Average Pain Interference With Sleep (11-point Likert Scale) at Baseline.(Baseline)
- Average Quality of Life Using the SF-36 Health Survey - Physical Component Summary (PCS) at Last Visit.(Last Visit)
- Average Quality of Life Using the SF-36 Health Survey - Mental Component Summary (MCS) at Baseline.(Baseline)
- Average Quality of Life Using the SF-36 Health Survey - Mental Component Summary (MCS) at Last Visit.(Last Visit)
- Average Quality of Life Using the SF-36 Health Survey - Physical Component Summary (PCS) at Baseline.(Baseline)