An Open-label follow-on Trial to Assess the Long-term Safety and Efficacy of Oral SPM 927 in Subjects With Diabetic Neuropathy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 69
- 主要终点
- Subject withdrawal due to adverse events
研究概览
简要总结
The primary objective of the trial is to assess the tolerability and safety of long-term SPM 927 administration in subjects with 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
- •Subject has successfully completed a previous trial with SPM 927 in diabetic neuropathy and, in the investigator's opinion, would benefit from long-term administration of SPM
- •Subject has stable, good or fair diabetic control (HbA1c ≤10% ).
排除标准
- •Subject has other conditions that cause neuropathic pain at least as severe as the diabetic pain, i.e. peripheral arterio-vascular disease.
- •Subject receives treatment for seizures.
- •Subject has had an amputation related to diabetes, other than toe amputation.
- •Subject has major skin ulcers.
- •Subject has clinically significant ECG abnormalities.
- •Subject expects to take during the study: TCAs, mexiletine hydrochloride, lidoderm patch, tramadol, AEDs, dextromethorphan, opioids, capsaicin, skeletal muscle relaxants, benzodiazepines or over-the-counter medications with centrally acting properties.
- •Subject has laboratory values which are outside the normal range and judged by the investigator to be clinically significant.
- •Subject has liver function tests (AST, ALT, alkaline phosphatase, total bilirubin, or GGT) ≥ 2x ULN at Visit
- •At Visit 1, subject has impaired renal function, i.e., creatinine clearance (ClCr) is lower than 60 mL/min.
研究组 & 干预措施
1
干预措施: SPM927/Lacosamide (Drug)
结局指标
主要结局
Subject withdrawal due to adverse events
时间窗: Assessments during whole course of the trial: spontaneously by the subject and observed by the investigators during site visits.
Assess the tolerability and safety of long-term SPM 927 administration in subjects with diabetic neuropathy
时间窗: Assessments during whole course of the trial: spontaneously by the subject and observed by the investigators during site visits
Changes laboratory, ECG and vital signs parameters.
时间窗: Assessments during whole course of the trial: spontaneously by the subject and observed by the investigators during site visits.
Changes in physical or neurological examination findings
时间窗: Assessments during whole course of the trial: spontaneously by the subject and observed by the investigators during site visits.
Adverse events reported spontaneously by the subject or observed by the investigator
时间窗: Assessments during whole course of the trial: spontaneously by the subject and observed by the investigators during site visits.
次要结局
- The secondary objective is to gather further information on the efficacy of SPM 927 in this indication.(Daily assessment during entire trial participation including assessments at site visits)
- Change in subject's perception of different neuropathic pain qualities during specific site visit(Daily assessment during entire trial participation including assessments at site visits)
- Time to exit (days) de to lack of efficacy of treatment(Daily assessment during entire trial participation including assessments at site visits)
- Within-subject change in average pain score: Daily assessments throughout the trial(Daily assessment during entire trial participation including assessments at site visits)
- Change in subject's perception of sleep and activity throughout the trial, daily assessments(Daily assessment during entire trial participation including assessments at site visits)
- Patient's Global Impression of Change in Pain (PGIC) during specific site visit(Daily assessment during entire trial participation including assessments at site visits)
- Clinical Global Impression of Change in Pain (CGIC): Assessments during specific site visit(Daily assessment during entire trial participation including assessments at site visits)
- Quality of life assessments during specific site visits(Daily assessment during entire trial participation including assessments at site visits)