An Open-Label, Multicenter, Extension Study to Evaluate the Long-Term Safety and Efficacy of Dexpramipexole (BIIB050) in Subjects With Amyotrophic Lateral Sclerosis - ENVISIO

Biogen Idec Research Limited0 个研究点目标入组 850 人开始时间: 2012年6月20日最近更新: 2013年5月27日

研究概览

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•1. Subject has the ability to understand the purpose and risks of the study and provide signed and dated informed consent (or have the consent confirmed by a witness if unable to write) and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
•2. Subject was enrolled in either Study CL211 or Study 223AS302.
•3. Subject has completed their last visit in Study CL211 or Study 223AS302.
•4. Subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 1 month (females) or 3 months (males) after their last dose of study treatment. For further details of contraceptive requirements for this 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 739
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 111

•1. Subject withdrew prematurely from Study CL211 or Study 223AS302.
•2. Subject permanently discontinued study treatment in Study CL211 or Study 223AS302 for any reason other than enrollment into this study.
•3. Subject from Study CL211 or Study 223AS302 has a significant change in medical history (including laboratory tests or a clinically significant condition) that in the opinion of the Investigator would impair the subject’s medical fitness for participation and preclude treatment.
•4. Female subject who is pregnant or breastfeeding.
•5. Subject is currently enrolled in any investigational drug study other than Study CL211 or Study 223AS302.
•6. Subject is taking pramipexole, other dopamine agonists, any other agent with dopaminergic activity, or any other disallowed concomitant medication
•7. Subject is unwilling or unable to comply with the requirements of the protocol including the presence of any condition (physical, mental, or social) that is likely to affect the subject’s ability to comply with the protocol. At a minimum, subjects who are not able to travel to the study site must be willing to agree to remote blood draws for clinical laboratory evaluations and telephone visits to report AEs, concomitant medications, and ALSFRS-R scores.

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