EUCTR2012-003647-30-BE进行中（未招募）1 期
A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by an active treatment period, to evaluate the efficacy, safety and tolerability of two doses of oral administration of laquinimod (0.6 mg/day or 1.2 mg/day) in subjects with relapsing remitting multiple sclerosis (RRMS) - CONCERTO
Teva Pharmaceutical Industries Ltd0 个研究点目标入组 2,199 人开始时间: 2012年10月8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
- 2,199
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 and documented MS diagnosis as defined by the Revised McDonald criteria, with relapse onset disease or a relapsing-remitting disease course.
- •2. Subjects must be ambulatory with Kurtzke EDSS score of 0-5.5 in both screening and randomization visits.
- •3.Subjects must be in a stable neurological condition, relapse-free and free of any corticosteroid treatment [intravenous (IV), intramuscular (IM) and/or per os (PO)] or adrenocorticotrophic hormone (ACTH), 60 days prior to randomization.
- •4. Subjects must have experienced at least one documented relapse in the 12 months prior to randomization.
- •5. Subjects must be between 18 and 55 years of age at screening, inclusive.
- •6. Subjects must have disease duration of not more than 15 years.
- •7. Women of child-bearing potential must practice an acceptable method of birth control until 30 days after the last dose of treatment was administered.
- •8. Subjects must be able to sign and date a written informed consent prior to entering the study.
- •9. Subjects must be willing and able to comply with the protocol requirements for the duration of the study.
- •10. Subjects must meet one or more of the following conditions:
- •- Patients who cannot receive other treatments for RRMS;
- •- Patients who have been unresponsive to their RRMS treatments;
- •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 1800
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Subjects with progressive forms of MS.
- •2. Subjects with Neuromyelitis Optica (NMO).
- •3. Use of experimental or investigational drugs (including dimethyl fumarate and Teriflunomide)and/or participation in drug clinical studies within 6 months prior to randomization.
- •4. Use of immunosuppressive agents, including fingolimod (Gilenya®) or cytotoxic agents, including Cyclophosphamide within 6 months prior to randomization.
- •5. Use of either of the following within 2 years prior to randomization: natalizumab (Tysabri®), rituximab, ocrelizumab, atacicept, belimumab, or ofatumumab.
- •6. Previous treatment with glatiramer acetate (Copaxone®) Interferon-ß (either 1a or 1b) or intravenous immunoglobulin (IVIG) within 2 months prior to randomization.
- •7. Chronic (more than 30 consecutive days) systemic (IV, IM or PO) corticosteroid treatment within 2 months prior to randomization.
- •8. Previous use of Mitoxantrone (Novantrone®), Cladribine, or alemtuzumab (CAMPATH-1H).
- •9. Previous use of laquinimod.
- •10. Previous total body irradiation or total lymphoid irradiation.
- •11. Previous stem cell treatment, autologous bone marrow transplantation or allogenic bone marrow transplantation.
- •12. Use of moderate/strong inhibitors of CYP3A4 within 2 weeks prior to randomization.
- •13. Use of inducers of CYP3A4 within 2 weeks prior to randomization.
- •14. Pregnancy or breastfeeding.
- •15. Serum levels =3xULN of either ALT or AST at screening.
- •16. Serum direct bilirubin which is =2xULN at screening.
- •17. Subjects with a clinically significant or unstable medical or surgical condition or any other condition that cannot be well-controlled by the allowed medications permitted in the study protocol that would preclude safe and complete study participation, as determined by medical history, physical examinations, ECG, laboratory tests MRI or chest X-ray.
- •18. A known history of sensitivity to gadolinium (Gd).
- •19. GFR = 60 mL/min at the screening visit.
- •20. Inability to successfully undergo MRI scanning.
- •21. Subjects who underwent endovascular treatment for Chronic Cerebrospinal Venous Insufficiency (CCSVI) within 3 months prior to randomization.
- •22. Known hypersensitivity that would preclude administration of laquinimod capsule, such as hypersensitivity to: mannitol, meglumine or sodium stearyl fumarate.
研究者
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