EUCTR2007-005450-23-IT进行中（未招募）不适用
A multinational, multicenter, randomized, parallel-group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of laquinimod over placebo in a double-blind design and of a reference arm of Interferon β-1a (Avonex) in a rater-blinded design - Bravo
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,200
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 [Ann Neurol 2005: 58:840-846], with a relapsing-remitting disease course.
- •2.Subjects must be ambulatory with Converted EDSS score of 0-5.5 in both screening and baseline visits.
- •3.Subjects must be in a stable neurological condition and free of corticosteroid treatment [intravenous (IV), intramuscular (IM) and/or per os (PO)] 30 days prior to screening (month -1) and between screening (month -1) and baseline (month 0) visits.
- •4.Subjects must have had experienced one of the following:
- •At least one documented relapse in the 12 months prior to screening, or
- •At least two documented relapses in the 24 months prior to screening, or
- •One documented relapse between 12 and 24 months prior to screening with at least one documented T1-Gd enhancing lesion in an MRI performed within 12 months prior to screening.
- •5.Subjects must be between 18 and 55 years of age, inclusive.
- •6.Subjects must have disease duration of at least 6 months (from the first symptom) prior to screening.
- •7.Women of child-bearing potential must practice an acceptable method of birth control [acceptable methods of birth control in this study include: surgical sterilization, intrauterine devices, oral contraceptive, contraceptive patch, long-acting injectable contraceptive, partner?s vasectomy or a double-barrier method (condom or diaphragm with spermicide)].
- •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.
- •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.An onset of relapse or any treatment with corticosteroids (intravenous [IV], intramuscular [IM] and/or per os [PO]) or ACTH between month -1 (screening) and 0 (baseline).
- •2.Subjects with progressive forms of MS.
- •3.Use of experimental or investigational drugs, and/or participation in drug clinical studies within the 6 months prior to screening.
- •4.Use of immunosuppressive (including Mitoxantrone (Novantrone) or cytotoxic agents within 6 months prior to the screening visit.
- •5.Previous use of either of the following: natalizumab (Tysabri), cladribine, laquinimod, Interferon beta-1a (Avonex or Rebif), Interferon beta-1b (Betaseron/Betaferon) or any other experimental Interferon-beta for MS.
- •6.Previous treatment with glatiramer acetate (Copaxone) or IVIG within 2 months prior to screening visit.
- •7.Chronic (more than 30 consecutive days) systemic (IV, PO or IM) corticosteroid treatment within 2 months prior to screening visit.
- •8.Previous total body irradiation or total lymphoid irradiation.
- •9.Previous stem-cell treatment, autologous bone marrow transplantation or allogenic bone marrow transplantation.
- •10.A known history of tuberculosis.
- •11.Acute infection within 2 weeks prior to baseline visit.
- •12.Major trauma or surgery within 2 weeks prior to baseline visit.
- •13.A history of vascular thrombosis (excluding catheter-site superficial venous thrombophlebitis).
- •14.A carrier state of factor V Leiden mutation (either homo- or heterozygous) by history or as disclosed at screening.
- •15.Positive screening test for Hepatitis B surface antigen or Hepatitis C antibody as disclosed at screening visit.
- •16.Known human immunodeficiency virus (HIV) positive status.
- •17.Use of inhibitors of CYP3A4 within 2 weeks prior to baseline visit (see Appendix 5).
- •18.Use of amiodarone within 2 years prior to screening visit.
- •19.Pregnancy or breastfeeding.
- •20.Subjects with a clinically significant or unstable medical or surgical condition that, in the Investigator?s opinion, would preclude safe and complete study participation, as determined by medical history, physical examinations, ECG, laboratory tests or chest X-ray. Such conditions may include:
- •A cardiovascular or pulmonary disorder that cannot be well-controlled by standard treatment permitted by the study protocol.
- •A gastrointestinal disorder that may affect the absorption of study medication.
- •Renal, metabolic or hematological diseases.
- •Thyroid disease: A subject with hyperthyroidism is not permitted to participate in the study. A subject with hypothyroidism may be permitted to participate in the study provided that he/she is clinically euthyroid and considered stable.
- •Any form of chronic liver disease, including known non-alcoholic steatohepatitis (fatty liver).
- •A ≥2xULN serum elevation of either of the following at screening: ALT, AST or direct bilirubin.
- •A QTc interval which is ≥ 450 msec, obtained from:
- •Two ECG recordings at screening visit OR
- •The mean value calculated from 3 baseline ECG recordings.
- •A family history of Long-QT syndrome.
- •A history of drug and/or alcohol abuse.
- •A current major psychiatric disorder, including schizophrenia or severe depression, with or without suicidal ideation.
- •A history of seizure disorder, with the last convulsion occurring within 12 months prior to screening visit.
- •21.A known history of sensitivity to Gadolinium.
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