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A Multicenter, Follow-Up Study to Assess Long-Term Electrophysiologic and Clinical Outcomes in Subjects Previously Enrolled in Study 215ON201
The primary objective of the study is to assess full-field visual evoked potential (FF-VEP) latency in subjects who were enrolled in Study NCT01721161 2 years (+ up to 12 months) after the last study visit. The secondary objective is to assess clinical progression and severity of central nervous system (CNS) demyelinating disease in subjects who were enrolled in Study NCT01721161 2 years (+ up to 12 months) after the last study visit. Intervention was administered in the previous study. The participants, investigator and outcome assessors remain blinded in this follow-up study.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Research Site
Sydney, New South Wales, Australia
Research Site
Parkville, Victoria, Australia
Research Site
Bruges, Belgium
Research Site
Ottawa, Ontario, Canada
Research Site
Olomouc, Czechia
Research Site
Prague, Czechia
Research Site
Glostrup Municipality, Denmark
Research Site
Bamberg, Germany
Research Site
Berlin, Germany
Research Site
Dresden, Germany
Start Date
March 10, 2016
Primary Completion Date
January 23, 2017
Completion Date
January 23, 2017
Last Updated
September 23, 2019
52
ACTUAL participants
Placebo
DRUG
BIIB033 100mg/Kg
DRUG
Lead Sponsor
Biogen
Data Source & Attribution
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