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临床试验/NCT00210652
NCT00210652已完成2 期

A Double-Blind, Placebo-Controlled, Dose-Titration Study to Determine Safety, Tolerability and Preliminary Efficacy of RWJ-333369 as Adjunctive Therapy in Subjects With Treatment-Resistant Partial Seizures (With or Without Secondary Generalization) or Primarily Generalized Tonic-Clonic Seizures

SK Life Science, Inc.0 个研究点目标入组 47 人开始时间: 2004年7月最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
47
主要终点
Adverse events as a measure of safety and tolerability

研究概览

简要总结

The purpose of this study is to evaluate the safety and preliminary effectiveness of the novel compound RWJ-333369 in patients with partial onset seizures who are currently being treated with 1 or 2 concomitant antiepileptic drugs.

详细描述

333369EPY2002 is the open-label extension study that follows the double-blind study 333369EPY2001. In an open label study such as 333369EPY2002, both the physician and the patient know the name of the assigned study medication. In a double blind study such as 333369EPY2001, neither the physician nor the patient knows the name of the assigned study medication. Patients who complete the double-blind treatment phase of study 333369EPY2001 will be eligible to enter the open-label extension study during which patients will transition through a blinded period to an open-label period with carisbamate (also referred to as RWJ-333369). RWJ-333369 is a new chemical compound with anticonvulsant activity that is currently under investigation as a treatment for epilepsy. Patients electing to enter the open-label extension phase will be supplied with both open-label carisbamate (RWJ-333369) and blinded study medication for the transition phase. During this transition phase (up to 21 days in length), the patient's dose of double-blind study drug will be gradually reduced and stopped and treatment with open-label RWJ-333369 will be started. Throughout the remainder of the open label extension phase, investigators will be allowed to make further adjustments of the dosage and schedule of carisbamate, including independent adjustment of the morning and evening doses, but a dosage of 1,200 mg/day may not be exceeded and increases in dosage must be in increments of no more than 200 mg/day. Patients who, in the judgment of the investigator, continue to benefit from treatment with RWJ-333369 may continue to receive the drug with follow up clinic visits every 3 months until RWJ 333369 is available by prescription or the program is terminated by the sponsor. Initial dose RWJ-333369 is 1 capsule (250 milligram (mg) taken twice daily. Dosage may be changed at weekly intervals. The maximum permitted dose will be 4 capsules (1000 mg), twice daily during dose titration. Double blind-treatment duration is up to 71 days with the option to continue treatment in an open-label study. Maximum dose in open-label study is 1200 mg/day

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
17 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • In order to enter the open label extension, the patient must have completed Study 333369EPY-2001.

排除标准

  • Patients who have seizures that cannot be quantitated accurately
  • patients with a history of nonepileptic seizures, serious systemic disease, progressive neurologic disorder, a major psychiatric disorder, status epilepticus in the past 3 months, vagal nerve stimulation discontinuation within the past 3 months
  • patients with a history of drug or alcohol abuse within the past 2 years
  • patients currently taking felbamate, vigabatrin, or tricyclic antidepressants
  • and female patients who are pregnant or nursing.

结局指标

主要结局

Adverse events as a measure of safety and tolerability

时间窗: At followup visits every 3 months up to the time RWJ-333369 is available by prescription or study is terminated by sponsor

次要结局

  • Seizure counts(Up to 3 months)

研究者

申办方类型
Industry
责任方
Sponsor

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