EUCTR2009-012989-30-LT进行中（未招募）1 期
A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-301 (ALLEGRO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis -
Teva Pharmaceutical Industries Ltd0 个研究点目标入组 542 人开始时间: 2009年10月2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
- 542
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 the Termination visit of MS-LAQ-301 (completion of all Termination visit activities) according to the MS-LAQ-301 protocol.
- •2. Women of child-bearing potential (for example women who are not
- •postmenopausal or surgically sterilized) must practice two acceptable
- •methods of birth control for the duration of the study and until 30 days
- •after the last dose of study medication [acceptable methods of birth
- •control in this open label extension phase include: intrauterine devices,
- •barrier methods (condom or diaphragm with spermicide), and hormonal
- •methods of birth control (e.g. oral contraceptive, contraceptive patch,
- •and long-acting injectable contraceptive)].
- •3.Subjects must be willing and able to comply with the protocol requirements for the duration of the study.
- •4.Subjects must be able to comprehend, sign and date a written informed consent prior to entering the MS-LAQ-301E 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 542
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion Criteria:
- •1.Premature discontinuation from the MS-LAQ-301 study, for any reason.
- •2.Pregnancy [according to urine dipstick ß-HCG test performed at Baseline (Month 0E) visit] or breastfeeding.
- •3.Subjects with clinically significant or unstable medical or surgical condition detected or worsened during the MS-LAQ-301 study, which preclude safe participation and completion of the MS-LAQ-301E study. Acute exacerbation of MS will not exclude participation in the MS-LAQ-301E study.
- •4.Use of inhibitors of CYP3A4 within 2 weeks prior to baseline visit (V0E, Month 0E).
研究者
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