Clinical Trial: BIIB033 In Acute Optic Neuritis (AON)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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

  • Change in Full-field Visual Evoked Potential (FF-VEP) Latency at Week 24: Intent-to-treat (ITT) Population [ Time Frame: 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 [ Time Frame: 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.


    • Original Primary Outcome: Change of latency of conduction velocity at 24 weeks from the baseline of unaffected fellow eye as measured by the Visual Evoked Potential p100 in milliseconds [ Time Frame: 24 weeks ]

    Current Secondary Outcome:

    • Percentage Change in Spectral-domain Optical Coherence Tomography (SD-OCT) Average Retinal Nerve Fiber Layer (RNFL) Thickness at Week 24: ITT Population [ Time Frame: Baseline, Week 24 ]
      Adjusted mean percentage change in thickness of the RNFL at Week 24 for the affected eye from the baseline of unaffected fellow eye as determined by SD-OCT. Percentage change is calculated as (affected eye - baseline of fellow eye)/baseline of fellow eye*100. Adjusted for the baseline RNFL thickness.
    • Percentage Change in SD-OCT Average RNFL Thickness at Week 24: Per-protocol Population [ Time Frame: Baseline, Week 24 ]
      Adjusted mean percentage change in thickness of the RNFL at Week 24 for the affected eye from the baseline of unaffected fellow eye as determined by SD-OCT. Percentage change is calculated as (affected eye - baseline of fellow eye)/baseline of fellow eye*100. Adjusted for the baseline RNFL thickness.
    • Change in SD-OCT Average Retinal Ganglion Cell Layer/Inner Plexiform Retinal Layer (RGCL/IPL) at Week 24: ITT Population [ Time Frame: Baseline, Week 24 ]
      Adjusted mean change in thicknesses of the RGCL/IPL at Week 24 for the affected eye from the baseline of unaffected fellow eye as determined by segmentation of SD-OCT. Adjusted for the baseline RGCL/IPL thickness.
    • Change in SD-OCT Average RGCL/IPL at Week 24: Per-protocol Population [ Time Frame: Baseline, Week 24 ]
      Adjusted mean change in thicknesses of the RGCL/IPL at Week 24 for the affected eye from the baseline of unaffected fellow eye as determined by segmentation of SD-OCT. Adjusted for the baseline RGCL/IPL thickness.
    • Change in Low-contrast Letter Acuity (LCLA) at Week 24: ITT Population [ Time Frame: Baseline, Week 24 ]
      Adjusted mean change in LCLA at Week 24 from baseline as determined by 1.25% and 2.5% low contrast Sloan letter charts, adjusted for the baseline LCLA value. The fellow eye is the reference eye for the inter-eye asymmetry. The range for LCLA assessment is 0-60.
    • Change in LCLA at Week 24: Per-protocol Population [ Time Frame: Baseline, Week 24 ]
      Adjusted mean change in LCLA at Week 24 from baseline as determined by 1.25% and 2.5% low contrast Sloan letter charts, adjusted for the baseline LCLA value. The fellow eye is the reference eye for the inter-eye asymmetry. The range for LCLA assessment is 0-60.
    • Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: 32 weeks ]
      An AE was any untoward medical occurrence that did not necessarily have a causal relationship with this treatment. An SAE was any untoward medical occurrence that at any dose: resulted in death; in the view of the Investigators, placed the subject at immediate risk of death (a life-threatening event); however, this did not include an event that, had it occurred in a more severe form, might have caused death; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigators, could have jeopardized the subject or may have required intervention to prevent one of the other outcomes listed in the definition above.
    • Summary of BIIB033 Concentration [ Time Frame: Up to 32 weeks ]
      One pre-dose pharmacokinetic (PK) sample and 1 post-dose PK sample (approximately between 1 and 3 hours after the end of IV infusion) were collected for all participants on Day 1 and at Weeks 4 through 20 (every 4 weeks). Additionally, only 1 PK sample was collected at Week 24 and Week 32. (There was no dosing on Week 24 and Week 32, so only one blood sample for BIIB033 concentration was taken.) Samples collected at early termination visits were treated as predose samples for the next scheduled visit.


    Original Secondary Outcome: Change of thickness of the retinal nerve fiber layer at Week 24 from the baseline of unaffected fellow eye as measured by spectral-domain optical coherence tomography in microns. [ Time Frame: 24 weeks ]

    Information By: Biogen

    Dates:
    Date Received: October 25, 2012
    Date Started: December 2012
    Date Completion:
    Last Updated: May 24, 2016
    Last Verified: May 2016