Long-Term Assessment of Remyelinating Therapy

Summary

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.

Timeline

Start

2016-03-10

Primary completion

2017-01-23

Completion

2017-01-23

Outcome

Missed primary endpoint

registry analysis (superiority test); Placebo vs BIIB033 (Opicinumab) 100 mg/kg; p =0.165; Mean Difference (Final Values) -6 (95% CI -14.56 to 2.57); ANCOVA NCT02657915 ↗

Drugs

Indications