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A Follow-On Trial to Assess the Long Term Safety and Efficacy of SPM 927 in Painful Distal Diabetic Neuropathy

2018年6月20日 更新者：UCB Pharma

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

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.

研究概览

地位

完全的

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (实际的)

451

阶段

  • 阶段2
  • 第三阶段

扩展访问

不再可用 查看扩展访问记录。

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • Alabama
      • Anniston、Alabama、美国
      • Hoover、Alabama、美国
      • Huntsville、Alabama、美国
      • Northport、Alabama、美国
      • Tuscaloosa、Alabama、美国
    • Arizona
      • Peoria、Arizona、美国
      • Phoenix、Arizona、美国
      • Tucson、Arizona、美国
    • Arkansas
      • Hot Springs、Arkansas、美国
      • Jonesboro、Arkansas、美国
      • Little Rock、Arkansas、美国
    • California
      • Irvine、California、美国
      • Los Angeles、California、美国
      • San Diego、California、美国
      • Santa Monica、California、美国
      • Spring Valley、California、美国
      • Tustin、California、美国
      • Walnut Creek、California、美国
    • Colorado
      • Denver、Colorado、美国
    • Connecticut
      • Stratford、Connecticut、美国
    • Delaware
      • Newark、Delaware、美国
      • Wilmington、Delaware、美国
    • Florida
      • Bradenton、Florida、美国
      • Clearwater、Florida、美国
      • Fort Myers、Florida、美国
      • New Port Richey、Florida、美国
      • Ocala、Florida、美国
      • Pembroke Pines、Florida、美国
      • Pinellas Park、Florida、美国
      • Saint Petersburg、Florida、美国
      • South Miami、Florida、美国
      • Sunrise、Florida、美国
      • Tallahassee、Florida、美国
    • Georgia
      • Marietta、Georgia、美国
    • Illinois
      • Chicago、Illinois、美国
      • Elk Grove Village、Illinois、美国
      • North Chicago、Illinois、美国
    • Indiana
      • Evansville、Indiana、美国
    • Iowa
      • West Des Moines、Iowa、美国
    • Kentucky
      • Crestview Hills、Kentucky、美国
      • Louisville、Kentucky、美国
      • Madisonville、Kentucky、美国
      • Paducah、Kentucky、美国
    • Maryland
      • Owings Mills、Maryland、美国
      • Towson、Maryland、美国
    • Massachusetts
      • Brockton、Massachusetts、美国
    • Michigan
      • Ann Arbor、Michigan、美国
    • Missouri
      • Saint Louis、Missouri、美国
    • Montana
      • Great Falls、Montana、美国
    • Nebraska
      • Omaha、Nebraska、美国
    • Nevada
      • Las Vegas、Nevada、美国
    • New Jersey
      • Lawrenceville、New Jersey、美国
      • Voorhees、New Jersey、美国
    • New York
      • Albany、New York、美国
      • Mineola、New York、美国
      • White Plains、New York、美国
    • North Carolina
      • Charlotte、North Carolina、美国
      • Greensboro、North Carolina、美国
      • Greenville、North Carolina、美国
      • Raleigh、North Carolina、美国
      • Winston-Salem、North Carolina、美国
    • Ohio
      • Cincinnati、Ohio、美国
      • Toledo、Ohio、美国
    • Oklahoma
      • Oklahoma City、Oklahoma、美国
      • Tulsa、Oklahoma、美国
    • Oregon
      • Medford、Oregon、美国
      • Portland、Oregon、美国
    • Pennsylvania
      • Upland、Pennsylvania、美国
    • South Carolina
      • Greer、South Carolina、美国
    • Tennessee
      • Bristol、Tennessee、美国
      • Nashville、Tennessee、美国
    • Texas
      • Amarillo、Texas、美国
      • Dallas、Texas、美国
      • Fort Worth、Texas、美国
      • Houston、Texas、美国
      • Richardson、Texas、美国
      • San Antonio、Texas、美国
    • Vermont
      • Bennington、Vermont、美国
    • Virginia
      • Richmond、Virginia、美国
      • Salem、Virginia、美国
      • Virginia Beach、Virginia、美国
    • Washington
      • Spokane、Washington、美国
      • Tacoma、Washington、美国
      • Wenatchee、Washington、美国

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

32年 至 81年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Subjects who completed Study SP665, SP742, or SP768 and, in the investigators opinion, might benefit from long-term administration of SPM 927. 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.

Exclusion Criteria:

  • 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 SP768.
  • 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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：1
Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
药品：lacosamide
Open-label treatment (two times per day) with film-coated tablets include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, and 600mg/day throughout individual study period.
其他名称：
  • SPM927

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Number of Subjects With Adverse Events (AEs) Reported Spontaneously by the Subject or Observed by the Investigator.
大体时间：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).
Throughout the study up to a maximum study period of 2.8 years

次要结果测量

结果测量
措施说明
大体时间
Change From Baseline in Average Daily Pain Score Using an 11-point Likert Scale (0-10).
大体时间：Baseline to end of entire treatment phase (maximum study period of 2.8 years).
Change from Baseline in average daily pain score using an 11-point Likert scale (0-10). On Likert scale, 0=no pain and 10=worst possible pain.
Baseline to end of entire treatment phase (maximum study period of 2.8 years).
Change From Baseline in Average Pain Score as Measured by a 100mm Visual Analogue Scale (VAS).
大体时间：Baseline to end of entire treatment phase (maximum study period of 2.8 years).
Change from Baseline in average pain score as measured by a 100mm Visual Analogue Scale (VAS). On VAS 0mm=no pain and 100mm=worst possible pain.
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.
大体时间：Baseline to Termination Visit
Patient's Global Impression of Change (PGIC) from Baseline in Pain. Original categorical responses are much worse, moderately worse, mildly worst, no change, mildly better, moderately better, and much better. Reported results are presented as Better (sum of mildly, moderately, or much better), No Change, or Worse (sum of mildly, moderately, or much worse).
Baseline to Termination Visit
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Intensity.
大体时间：Baseline to Termination Visit
Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) for intensity of pain where 0=no pain and 10=most intense pain sensation imaginable.
Baseline to Termination Visit
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Sharpness
大体时间：Baseline to Termination Visit
Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) for sharpness of pain where 0=not sharp and 10=most sharp sensation imaginable ("like a knife").
Baseline to Termination Visit
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Heat
大体时间：Baseline to Termination Visit
Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with heat sensation where 0=not hot and 10=the most hot sensation imaginable ("on fire").
Baseline to Termination Visit
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Dullness
大体时间：Baseline to Termination Visit
Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with dullness of pain where 0=not dull and 10=most dull sensation imaginable.
Baseline to Termination Visit
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Cold
大体时间：Baseline to Termination Visit
Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with cold sensation where 0=not cold and 10=most cold sensation imaginable ("freezing").
Baseline to Termination Visit
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Sensitivity
大体时间：Baseline to Termination Visit
Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with sensitivity of pain where 0=not sensitive and 10=most sensitive sensation imaginable ("raw skin").
Baseline to Termination Visit
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Itchiness
大体时间：Baseline to Termination Visit
Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with itchiness where 0=not itchy and 10=most itchy sensation imaginable ("like poison oak").
Baseline to Termination Visit
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Unpleasantness
大体时间：Baseline to Termination Visit
Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with unpleasantness where 0=not pleasant and 10=most unpleasant sensation imaginable ("intolerable").
Baseline to Termination Visit
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Deep Pain
大体时间：Baseline to Termination Visit
Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with deep pain where 0=no deep pain and 10=most intense deep pain sensation imaginable.
Baseline to Termination Visit
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Surface Pain
大体时间：Baseline to Termination Visit
Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with surface pain where 0=no surface pain and 10=most intense surface pain imaginable.
Baseline to Termination Visit
Change From Baseline in Average Pain Interference With Sleep (11-point Likert Scale)
大体时间：Baseline to end of entire treatment phase visit
Change from Baseline in average pain interference with sleep (11-point Likert scale) where 0=no interference with sleep and 10=worst possible interference with sleep.
Baseline to end of entire treatment phase visit
Change From Baseline in Average Pain Interference With Activity (11-point Likert Scale)
大体时间：Baseline to end of entire treatment phase visit
Change from Baseline in average pain interference with activity (11-point Likert scale) where 0=no interfence with activity and 10=worst possible interference with activity.
Baseline to end of entire treatment phase visit
Change From Baseline in Quality of Life Using the SF-36 Health Survey - Physical Component Summary (PCS)
大体时间：Baseline to Termination Visit
Change from Baseline in quality of life using the SF-36 Health Survey - Physical Component Summary (PCS). Values range from 0 to 100 with high values indicating a good condition. Positive change in baseline values indicate improvement in quality of life.
Baseline to Termination Visit
Change From Baseline in Quality of Life Using the SF-36 Health Survey - Mental Component Summary (MCS)
大体时间：Baseline to Termination Visit
Change from Baseline in quality of life using the SF-36 Health Survey - Mental Component Summary (MCS). Values range from 0 to 100 with high values indicating a good condition. Positive change in baseline values indicate improvement in quality of life.
Baseline to Termination Visit

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

UCB Pharma

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2004年9月1日

初级完成 (实际的)

2008年7月1日

研究完成 (实际的)

2008年7月1日

研究注册日期

首次提交

2005年10月6日

首先提交符合 QC 标准的

2005年10月6日

首次发布 (估计)

2005年10月10日

研究记录更新

最后更新发布 (实际的)

2018年7月17日

上次提交的符合 QC 标准的更新

2018年6月20日

最后验证

2017年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • SP0745

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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赞助者和合作者

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药物干预

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条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
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