An Open-label Safety Extension Study of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) Patients Treated With Riluzole
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 271
- 试验地点
- 15
- 主要终点
- The primary outcome measure will be the safety assessment.
研究概览
简要总结
The purpose of the assay is to assess the safety of TRO19622 330 mg QD as add-on therapy to riluzole 50 mg bid in the treatment of patients suffering from ALS, after completion of the preceding clinical trial (TRO19622 CL E Q 1015-1) in an open label extension.
详细描述
Entry of a patient into this safety study is intended to occur immediately after the patient has finished participating in the preceding efficacy study (Protocol TRO19622 CL E Q 1015-1).
The Investigator will explain to the patients the nature of this open-label safety study, its procedures, requirements and restrictions so as to obtain their written informed consent.
Each patient will be treated with olesoxime (TRO19622) until the results of the double-blind trial become available with a maximum of 15 months.
Follow-up visits will take place every 3 months (+/- 2 weeks).
Safety assessments will be performed at all visits (every 3 months).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have completed the 18-month safety and efficacy study of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzole (Protocol TRO19622 CL E Q 1015-1).
- •Both the investigator and the patient will decide based on previous good tolerance and other clinical grounds whether or not to participate to the open-label extension.
- •If patients were on anti-vitamin K during the double-blind period, when entering the open-label extension, coagulation tests should be monitored in exactly the same conditions as if a new anticoagulant treatment was initiated and the dose of anti-vitamin K should be adjusted accordingly.
- •Patients enrolling from this prior safety and efficacy study must:
- •If female of childbearing age of potential, continue to use adequate birth control methods and have a negative serum pregnancy test at the preceding double-blind protocol termination visit. Male and female partners must agree to use an effective method of birth control during their participation in the trial and for at least 15 days after the last IMP dose. Both partners must use reliable methods of contraception with 2 independent methods. The following measures are acceptable: Hormone contraceptives (e.g. oral contraceptives or comparable methods), intrauterine device, condoms with spermicidal coating or in combination with spermicidal creams, total abstinence or sterilisation performed in the past.
- •Be able to follow the investigator's instructions and be able to comply with the visit schedule and visit requirements; and
- •Sign a written informed consent.
排除标准
- •Patients may not participate in this study if they have an ongoing, unresolved, clinically significant medical problem (including patients having experienced serious adverse events or non-serious, but medically significant adverse events during the preceding safety and efficacy study that was assessed to be related to the study medication by the investigator) that in the judgment of the investigator would make it unsafe for the patient to participate in the trial.
研究组 & 干预措施
Olesoxime
All patients will receive the IMP as add-on to riluzole 50 mg bid orally, 50 mg morning and evening on an empty stomach ie at least 20 min before the meal.
干预措施: TRO19622 (Drug)
结局指标
主要结局
The primary outcome measure will be the safety assessment.
时间窗: Safety assessment will be calculated from the date of enrollment for a maximum of 15 months.
safety criteria will be: * Occurrence of AEs, * Physical examination, * Laboratory tests, * Vital signs and ECG,
次要结局
- Secondary Outcome Measures(Every 3 month, from the date of enrollment for a maximum of 15 months.)