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
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 1,047
- 试验地点
- 144
- 主要终点
- Participants With Treatment-Emergent Adverse Events (TEAEs)
研究概览
简要总结
To make laquinimod 0.6 mg available for all subjects who completed the placebo-controlled MS-LAQ-302 study according to the protocol and 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must have completed the Termination visit of MS-LAQ-302 (completion of all Termination visit activities) according to the MS-LAQ-302 protocol.
- •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, partner's 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..
- •Subjects must be willing and able to comply with the protocol requirements for the duration of the study.
- •Subjects must be able to comprehend, sign and date a written informed consent prior to entering the MS-LAQ-302E study.
排除标准
- •Premature discontinuation from the MS-LAQ-302 study, for any reason.
- •Pregnancy [according to urine dipstick β-HCG test performed at Baseline (Month 0E) visit] or breastfeeding.
- •Subjects with clinically significant or unstable medical or surgical condition detected or worsened during the MS-LAQ-302 study, which preclude safe participation and completion of the MS-LAQ-302E study. Acute exacerbation of MS will not exclude participation in the MS-LAQ-302E study.
- •Use of inhibitors of CYP3A4 within 2 weeks prior to baseline visit (V0E, Month 0E).
研究组 & 干预措施
Experimental: Laquinimod
One capsule containing 0.6 mg laquinimod to be administered orally once daily.
干预措施: Laquinimod (Drug)
结局指标
主要结局
Participants With Treatment-Emergent Adverse Events (TEAEs)
时间窗: Day 1 up to 7.13 years
A treatment-emergent adverse event was defined as any untoward medical occurrence that develops or worsens in severity following start of treatment and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator. Serious AEs (SAE) include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes. TEAEs associated with cancer, ischemic heart disease, cerebrovascular events, and arthritis were considered to be of special interest.
次要结局
- Participants With Potentially Clinically Significant Abnormal Vital Signs(Baseline (Day 0 for extension), Day 1 up to 7.13 years)
- Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study(Baseline (Day 0), Day 1 to 7.13 years)
- Participants With Electrocardiogram (ECG) Fiindings That Shifted From Baseline to Any Time During the Study(Baseline (Day 0), Day 1 to 7.13 years)
- Participants With Serum Hematology Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study(Baseline (Day 0), Day 1 to 7.13 years)