NCT00237458已完成2 期
An Open-label Continuation Trial to Assess the Continued Efficacy and Safety of Ascending Doses of Lacosamide in Subjects With Chronic Refractory Neuropathic Pain
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 7
- 主要终点
- Number of Subjects Reporting At Least 1 Treatment-Emergent Adverse Event (TEAE) During The Treatment Period.
研究概览
简要总结
This trial is the follow-on trial to a preceeding open-label trial which included patients with chronic refractory neuropathic pain. It is conducted at one site in the United Kingdom and the patient enrollment is completed. The patients had successfully completed the above mentioned trial and, in the investigator's opinion, would benefit from long-term administration of Lacosamide. After a 1-week run-in phase the patients were uptitrated to their optimal dose and then continued into the maintenance phase. Different pain qualities are assessed by a patient's diary.
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 is informed and given ample time and opportunity to think about her/his participation in this extension trial and has given her/his written informed consent
- •Subject met all inclusion criteria defined in the SP611 trial with SPM927 at the time of enrollment into trial SP611
- •Subject has successfully completed trial SP611 and, in the investigator's opinion, would benefit from long-term administration of SPM927
- •Subject is willing and able to comply with all trial requirements, including the ability to complete trial questionnaires
排除标准
- •Subject previously participated in this trial
- •Subject has participated in another trial of an investigational drug within the last 3 months (excluding trial SP611) or is currently participating in another trial of an investigational drug
- •Subject has had prior therapy with a Nonsteroidal Anti-inflammatory Drug (NSAID) or Anti-epileptic Drug (AED) within 28 days prior to the Eligibility Visit
- •Subject has evidence or history of significant Cardiovascular Disease within 12 months prior to the Eligibility Visit
- •Subject has laboratory values, which are outside the normal range and judged by the Investigator to be clinically significant
- •Subject has abnormal Renal or Hepatic function
- •Subject has a history of Malignancies with the exception of subjects with a documented disease-free interval of 5 years or more
- •Subject has a history of chronic alcohol or drug abuse within the last 12 months
- •Subject has any medical or psychiatric condition which, in the opinion of the Investigator, could jeopardize or compromise the subject's ability to participate in this continuation trial
- •Subject with a known history of severe Anaphylactic Reaction and/or serious or life threatening Blood Dyscrasias
研究组 & 干预措施
Lacosamide
Experimental
Open-label active treatment
干预措施: Lacosamide (Drug)
结局指标
主要结局
Number of Subjects Reporting At Least 1 Treatment-Emergent Adverse Event (TEAE) During The Treatment Period.
时间窗: From Baseline Visit to Final Week of Treatment (approximately 10 years)
Number of Subjects Withdrawing From Study Due To A Treatment-Emergent Adverse Event (TEAE) During The Treatment Period.
时间窗: From Baseline Visit to Final Week of Treatment (approximately 10 years)
次要结局
- Within-Subject Change In Average Daily Pain Score During the Treatment Period.(From Baseline Visit to Final Week of Treatment (approximately 9 years))
- Within-Subject Change In The Perception Of Each Of The Individual Cardinal Symptoms of Pain During The Treatment Period - Burning.(From Baseline Visit to Final Week of Treatment (approximately 9 years))
- Within-Subject Change In The Perception Of Each Of The Individual Cardinal Symptoms of Pain During The Treatment Period - Numbness.(From Baseline Visit to Final Week of Treatment (approximately 9 years))
- Within-Subject Change In The Perception Of Each Of The Individual Cardinal Symptoms of Pain During The Treatment Period - Allodynia.(From Baseline Visit to Final Week of Treatment (approximately 9 years))
- Within-Subject Change In The Perception Of Each Of The Individual Cardinal Symptoms of Pain During The Treatment Period - Shooting.(From Baseline Visit to Final Week of Treatment (approximately 9 years))
- Subject's Global Impression of Change In Pain During The Treatment Period.(From Baseline Visit to Final Week of Treatment (approximately 9 years))
- Investigator's Global Impression of Change In Pain During The Treatment Period.(From Baseline Visit to Final Week of Treatment (approximately 9 years))
- Within-Subject Change In The Perception Of Each Of The Individual Cardinal Symptoms of Pain During The Treatment Period - Paraesthesiae.(From Baseline Visit to Final Week of Treatment (approximately 9 years))
- Percentage of Days With Concomitant Pain ("Rescue") Medications Taken During Baseline Phase.(Baseline Period (approximately 1 week))
- Percentage of Days With Concomitant Pain ("Rescue") Medications Taken During Titration Phase.(Titration Period (approximately 6 weeks))
- Percentage of Days With Concomitant Pain ("Rescue") Medications Taken During Titration and Treatment Phases.(From Titration Phase through Treatment Phase (approximately 9 years))
研究者
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