CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 52 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
BIIB033 100mg/Kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02657915
NCT02657915Phase 2Completed
CompareCT.gov

A Multicenter, Follow-Up Study to Assess Long-Term Electrophysiologic and Clinical Outcomes in Subjects Previously Enrolled in Study 215ON201

Biogen·interventional·Posted Jan 18, 2016·Updated Sep 23, 2019

In Brief

A Phase 2 clinical trial evaluating Placebo and BIIB033 100mg/Kg for Acute Optic Neuritis. Completed, enrolled 52 participants across 23 sites in 11 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Optic Neuritis
CountriesAustralia, Belgium, Canada, Czechia, Denmark, Germany, Hungary, Italy, Spain, Sweden, United Kingdom
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 18, 2016
Enrollment StartMar 10, 2016
Primary CompletionJan 23, 2017
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 10.5 years ago

Interventions

Placebodrug

Administered as specified in the treatment arm.

BIIB033 100mg/Kgdrug

Administered as specified in the treatment arm.