EUCTR2007-005450-23-LT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 ß-1a (Avonex®) in a rater-blinded design - BRAVO
Teva Pharmaceutical Industries Ltd0 个研究点目标入组 1,200 人开始时间: 2008年5月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 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.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-protection method (condom or diaphragm with spermicide)].
- •7.Subjects must be able to sign and date a written informed consent prior to entering the study.
- •8.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. Known human immunodeficiency virus (HIV) positive status.
- •14. Use of inhibitors of CYP3A4 within 2 weeks prior to baseline visit (see Appendix 5)
- •15. Use of amiodarone within 2 years prior to screening visit.
- •16. Pregnancy or breastfeeding.
- •17. A =3xULN serum elevation of either ALT or AST at screening.
- •18. Serum direct bilirubin which is =2xULN at screening
- •19. A QTc interval which is > 450 msec (according to machine output), obtained from:
- •-Two ECG recordings at screening visit OR
- •- The mean value calculated from 3 baseline ECG recordings
- •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.
- •- Liver disease, such as cirrhosis.
- •- 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 convulsive episode occurring within
- •12 months prior to screening visit.
- •21. A known history of sensitivity to Gadolinium.
- •22. Inability to successfully undergo MRI scanning.
- •23. A known drug hypersensitivity that would preclude administration of
- •laquinimod, such as hypersensitivity to: mannitol, meglumine or sodium stearyl
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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 ß-1a (Avonex®) in a rater-blinded design - BRAVOEUCTR2007-005450-23-DETeva Pharmaceutical Industries Ltd1,200