A Long-Term International, Extension of Study GNC-003, with GNbAC1 in Patients with Relapsing Remitting Multiple Sclerosis - ANGEL-MS

GeNeuro SA0 个研究点目标入组 240 人开始时间: 2017年9月12日最近更新: 2018年11月6日

研究概览

暂无简介。

•- Patients must have completed Period 2 of study GNC-003 and must meet all eligibility criteria for the GNC-004 study;
•- Patients (male or female with reproductive potential) must agree to use highly effective methods of birth control
•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 240
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- Patients not having completed study GNC-003.
•- Emergence of any disease diagnosis during the course of study GNC-003 that is not MS and could better explain the patient’s neurological signs and symptoms.
•- Any major medical or psychiatric disorder that could put the patient at undue risk during the study, according to the investigator’s opinion, or that would affect the capacity of the patient to fulfill the requirements of the study, including: Schizophrenia, bipolar disorder, or major depressive disorder, History of suicide attempt, or current suicidal ideation, current alcohol or drug abuse.
•- Body weight<40kg
•- Patients not able to follow study instructions, or not able to follow the study assessments defined by the protocol.
•- Forbidden concomitant treatments
•- Legal incapacity or limited legal capacity.
•- Pregnancy.
•- Female patients of childbearing potential (FPCBP) or procreative male patients (PMP), not willing to use highly effective contraceptive methods throughout the study duration and at least until 5 months after the last study treatment.

发起方