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Long-Term Assessment of Remyelinating Therapy

NCT02657915 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2019-09-23

Study results available
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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.

Conditions

  • Acute Optic Neuritis

Interventions

DRUG

Placebo

Administered as specified in the treatment arm.

DRUG

BIIB033 100mg/Kg

Administered as specified in the treatment arm.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Biogen

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-10
Primary Completion
2017-01-23
Completion
2017-01-23

Countries

  • Australia
  • Belgium
  • Canada
  • Czechia
  • Denmark
  • Germany
  • Hungary
  • Italy
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02657915 on ClinicalTrials.gov