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A Randomized, Double-Blind, Parallel-Group, Placebo Controlled Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Subjects With First Episode of Acute Optic Neuritis
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.
Details
| Lead sponsor | Biogen |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 82 |
| Start date | 2012-12 |
| Completion | 2014-10 |
Conditions
- Acute Optic Neuritis
Interventions
- BIIB033 (anti-LINGO-1 mAb)
- Placebo
Primary outcomes
- Change in Full-field Visual Evoked Potential (FF-VEP) Latency at Week 24: Intent-to-treat (ITT) Population — Baseline, Week 24
Adjusted mean change in optic nerve conduction velocity (NCV) at Week 24 for the affected eye from the baseline of unaffected fellow eye as determined by FF-VEP. Adjusted for the baseline latency of fellow eye. - Change in FF-VEP Latency at Week 24: Per-protocol Population — Baseline, Week 24
Adjusted mean change in optic nerve conduction velocity (NCV) at Week 24 for the affected eye from the baseline of unaffected fellow eye as determined by FF-VEP. Adjusted for the baseline latency of fellow eye.
Countries
Australia, Belgium, Canada, Czechia, Denmark, Germany, Hungary, Italy, Spain, Sweden, United Kingdom