NL-OMON43625已完成3 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 - Allegro Extension
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- TEVA Pharma
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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 must practice an acceptable method of birth control during the study and up to 30 days after the last dose of study drug.
- •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-301 study
排除标准
- •1)Premature discontinuation from the MS-LAQ-301 study, for any reason
- •2)Pregancy [according to urine dipstick β-HCG test perfomed at Baseline (Month 0E) visit] or breastfeeding.
- •3)Subjects with clinically significant or unstable medical or surgical condition detected or worsened during MS-LAQ-301 study, which preclude safe partcipation 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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