RENEWed 215ON203
Research type
Research Study
Full title
A Multicenter, Follow-Up Study to Assess Long-Term Electrophysiologic and Clinical Outcomes in Subjects Previously Enrolled in Study 215ON201.
IRAS ID
193218
Contact name
Gordon Plant
Contact email
Sponsor organisation
Biogen Idec Research Limited
Eudract number
2015-003618-26
Duration of Study in the UK
0 years, 9 months, 17 days
Research summary
The purpose of this follow-up study is to determine the long term electrophysiologic and clinical outcomes in subjects previously enrolled in Study 215ON201 for Acute Optic Neuritis (AON), which looked at whether the drug BIIB033 could help to repair the nerves of the affected eye.
One group is planned, with eligible subjects who have participated in and received at least 1 dose of BIIB033 or placebo in Study 215ON201. Dosing was completed 2 years (+ 4 months) prior to enrollment in this follow-up study. No additional drug or placebo will be administered.This study will assess the electrical conduction of the visual pathway. This is done with the use of a visual stimulus, which leads to an electrical potential firing. Eligible subjects will be enrolled at 2 years after their last study visit (Week 32) or projected Week 32 (+ 4 months) visit if the subject did not complete all visits in Study 215ON201. The study period will consist of an approximately 1-day visit.
This study is sponsored by Biogen. A maximum of 82 research participants in approximately 33 study centres globally, will take part in this study.
REC name
West of Scotland REC 1
REC reference
16/WS/0054
Date of REC Opinion
18 Apr 2016
REC opinion
Further Information Favourable Opinion