An Open-Label Safety Extension Study of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzole.

TROPHOS SA0 个研究点开始时间: 2010年11月12日最近更新: 2012年10月22日

适应症

试验速览

暂无简介。

•- 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 theopen-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,
•- 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.
•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) yes
•F.1.3.1 Number of subjects for this age range

•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.

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