EUCTR2004-003943-28-CZ进行中（未招募）不适用
A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the efficacy, tolerability and safety of two doses 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 264 人开始时间: 2005年2月9日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 264
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 a confirmed MS diagnosis as defined by the McDonald criteria (Ann Neurol, July 2001).
- •2. Subjects must have an R-R MS disease course.
- •3. Subjects must have at least one documented relapse in the 12 months prior to screening.
- •4. Subjects must have at least one gadolinium-enhanced (Gd; gadopentetic acid) lesion on their screening MRI scan.
- •5. Subjects must be ambulatory with a Kurtzke EDSS score of 1.0-5.0 (converted).
- •6. Subjects must be between 18-50 years of age, inclusive.
- •7. Subjects must be relapse-free and off corticosteroids or ACTH for at least 30 days prior to the MRI scan at screening.
- •8. Subjects must be relapse-free and off corticosteroids between screening and randomization (baseline V0).
- •9. Women of child-bearing potential must practice a reliable method of birth control. (Acceptable methods of birth control in this study include: surgical sterilization, intrauterine devices and diaphragms with spermicide; oral contraception must be accompanied by an additional method of birth control.)
- •10. Subjects must be willing and able to comply with the protocol requirements for the duration of the study.
- •11. Subjects must be able to give signed, written, informed consent prior to entering the 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. Subjects who suffer from any form of progressive MS.
- •2. Use of immunosuppressive or cytotoxic treatments within 6 months prior to the screening visit (including azathioprine, cyclophosphamide methotrexate).
- •3. Use of experimental drugs, and/or participation in drug clinical studies within the 6 months prior to screening.
- •4. Previous treatment with immunomodulators (including IFNß 1a and 1b glatiramer acetate, laquinimod and IVIG) within the 2 months prior to screening.
- •5. Use of potent inhibitors of CYP3A4, such as oral ketoconazole or erythromycin within 2 weeks prior to baseline visit (see full list in Appendix 6).
- •6. Previous use of amiodarone.
- •7. Use of fluoxetine one month prior to baseline visit.
- •8. Use of the following substrates of CYP1A2: theophylline and warfarin within 2 weeks prior to screening.
- •9. Previous treatment with cladribine within the last 2 years prior to screening visit.
- •10. Subjects for whom potential immunosuppression would be contraindicated, for example: Hepatitis B/C or HIV.
- •11. Previous total body irradiation or total lymphoid irradiation.
- •12. Chronic corticosteroid treatment (30 or more consecutive days) within the 2 months prior to screening.
- •13. Pregnancy or breastfeeding.
- •14. Subjects with a clinically significant or unstable medical or surgical condition that would preclude safe and complete study participation, as determined by medical history, physical exams, ECG, abnormal laboratory tests, chest X-ray.
- •15. The subject's inability to give informed consent, or to complete the study, or if the subject is considered by the investigator to be, for any reason, an unsuitable candidate for this study.
- •16. A known history of sensitivity to Gd.
- •17. Inability to successfully undergo MRI scanning.
研究者
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