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BIIB033 In Acute Optic Neuritis (AON)

NCT01721161 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2016-06-30

Study results available
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Summary

The primary objective of the study is to evaluate the efficacy of BIIB033 in subjects with their first episode of unilateral acute optic neuritis (AON). The secondary objective of this study is to assess the safety, tolerability, and pharmacokinetics (PK) of BIIB033 in this study population.

Conditions

  • Acute Optic Neuritis

Interventions

BIOLOGICAL

BIIB033 (anti-LINGO-1 mAb)

100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses).

DRUG

Placebo

via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Biogen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2014-10-31
Completion
2014-10-31

Countries

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

Study Locations

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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 NCT01721161 on ClinicalTrials.gov