EUCTR2005-004334-41-ES进行中（未招募）1 期
An active extension of LAQ/5062 study. A multinational, multicenter, randomized, double-blind, parallel-group study, to evaluate the efficacy, tolerability and safety of two doses (0.3 mg and 0.6 mg) of laquinimod, orally administered in relapsing remitting (R-R) multiple sclerosis (MS) subjects
Teva Pharmaceutical Industries Ltd0 个研究点目标入组 257 人开始时间: 2005年11月10日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 257
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Subjects must have completed 36 weeks of treatment in the LAQ/5062 study and all its activities in accordance with the protocol.
- •2. Women of child- bearing potential must practice a reliable method of birth control. (Acceptable methods of birth control in this study include: double barrier methods such as diaphragms with spermicide, condoms and spermicide. Also intrauterine devices; hormonal contraception must be accompanied by an additional method of birth control.).
- •3. Subjects must be willing and able to comply with the protocol requirements for the duration of the study
- •4. Subjects must give signed, written informed consent prior to entering this extension study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Premature discontinuation from core study LAQ/5062 for any reason.
- •2. Pregnancy or breastfeeding.
- •3. Subjects with clinically significant or unstable medical or surgical condition, detected or worsened during the core study, which would preclude safe and complete study participation.
研究者
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