EUCTR2009-012989-30-IT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 - ND
Teva Pharmaceutical Industries Ltd0 个研究点目标入组 1,000 人开始时间: 2009年9月11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
- 1,000
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 must practice an acceptable method of birth control [acceptable methods of birth control in this open label extension phase include: surgical sterilization, intrauterine devices, oral contraceptive, contraceptive patch (or hormone-releasing vaginal ring), long-acting injectable contraceptive, partners vasectomy or double-barrier method (condom or diaphragm with spermicide)] during the study and up to 30 days after the last dose of the 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-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
- •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 the MS-LAQ-301 study, for any reason. 2. Pregnancy [according to urine dipstick β-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
相似试验
进行中（未招募）
1 期
A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-302 (BRAVO) 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 -aquinimod is developed for the treatment of relapsing remitting multiple sclerosis.MedDRA version: 9.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisEUCTR2009-015815-42-SKTeva Pharmaceutical Industries Ltd1,245
进行中（未招募）
1 期
A clinical study in subjects with multiple sclerosis who successfullycompleted the MS-LAQ-301 (ALLEGRO) study, to assess the safety oflaquinimod (experimental drug) when taken for a long period of time andhow it affects the course of the disease.aquinimod is developed for the treatment of relapsing remitting multiple sclerosis.MedDRA version: 19.0Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersEUCTR2009-012989-30-EETeva Pharmaceutical Industries Ltd542
进行中（未招募）
1 期
A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-302 (BRAVO) 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 - NDaquinimod is developed for the treatment of relapsing remitting multiple sclerosis.MedDRA version: 9.1Level: PTClassification code 10063399EUCTR2009-015815-42-ITTeva Pharmaceutical Industries Ltd1,245
进行中（未招募）
1 期
A clinical study in subjects with multiple sclerosis who successfullycompleted the MS-LAQ-301 (ALLEGRO) study, to assess the safety oflaquinimod (experimental drug) when taken for a long period of time andhow it affects the course of the disease.aquinimod is developed for the treatment of relapsing remitting multiple sclerosis.MedDRA version: 19.0Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersEUCTR2009-012989-30-CZTeva Pharmaceutical Industries Ltd542
进行中（未招募）
1 期
A clinical study in subjects with multiple sclerosis who successfullycompleted the MS-LAQ-301 (ALLEGRO) study, to assess the safety oflaquinimod (experimental drug) when taken for a long period of time andhow it affects the course of the disease.EUCTR2009-012989-30-NLTeva Pharmaceutical Industries Ltd632