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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01721161
Registration number
NCT01721161
Ethics application status
Date submitted
25/10/2012
Date registered
4/11/2012
Date last updated
30/06/2016
Titles & IDs
Public title
BIIB033 In Acute Optic Neuritis (AON)
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Scientific 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 Optic Neuritis
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Secondary ID [1]
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215ON201
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Acute Optic Neuritis
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Condition category
Condition code
Neurological
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Other neurological disorders
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Eye
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Diseases / disorders of the eye
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - BIIB033 (anti-LINGO-1 mAb)
Treatment: Drugs - Placebo
Experimental: BIIB033 - Participants will receive BIIB033 once every 4 weeks for 20 weeks (a total of 6 doses).
Placebo Comparator: Placebo - Participants will receive Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses).
Other interventions: BIIB033 (anti-LINGO-1 mAb)
100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses).
Treatment: Drugs: Placebo
via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
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Intervention code [1]
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Other interventions
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in Full-field Visual Evoked Potential (FF-VEP) Latency at Week 24: Intent-to-treat (ITT) Population
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline, Week 24
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Primary outcome [2]
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Change in FF-VEP Latency at Week 24: Per-protocol Population
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline, Week 24
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Secondary outcome [1]
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Percentage Change in Spectral-domain Optical Coherence Tomography (SD-OCT) Average Retinal Nerve Fiber Layer (RNFL) Thickness at Week 24: ITT Population
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline, Week 24
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Secondary outcome [2]
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Percentage Change in SD-OCT Average RNFL Thickness at Week 24: Per-protocol Population
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline, Week 24
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Secondary outcome [3]
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Change in SD-OCT Average Retinal Ganglion Cell Layer/Inner Plexiform Retinal Layer (RGCL/IPL) at Week 24: ITT Population
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline, Week 24
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Secondary outcome [4]
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Change in SD-OCT Average RGCL/IPL at Week 24: Per-protocol Population
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Assessment method [4]
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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.
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Timepoint [4]
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Baseline, Week 24
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Secondary outcome [5]
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Change in Low-contrast Letter Acuity (LCLA) at Week 24: ITT Population
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Assessment method [5]
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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.
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Timepoint [5]
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Baseline, Week 24
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Secondary outcome [6]
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Change in LCLA at Week 24: Per-protocol Population
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Assessment method [6]
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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.
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Timepoint [6]
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Baseline, Week 24
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Secondary outcome [7]
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Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
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Assessment method [7]
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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.
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Timepoint [7]
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32 weeks
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Secondary outcome [8]
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Summary of BIIB033 Concentration
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Assessment method [8]
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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.
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Timepoint [8]
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Up to 32 weeks
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Eligibility
Key inclusion criteria
Key
- Ability to provide written consent and any authorization required by law.
- Confirmed diagnosis of AON
- All male or female subjects of childbearing potential must practice effective
contraception during the study and be willing and able to continue contraception for
at least 6 months after their last dose of study treatment.
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Minimum age
18
Years
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Maximum age
55
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Prior episode(s) of optic neuritis or loss of vision not due to AON.
- Subjects with an established diagnosis of multiple sclerosis are excluded except if
newly diagnosed based on the current episode of AON and positive brain magnetic
resonance imaging results consistent with the 2010 revisions to the McDonald's
criteria.
- Previous history of a clinically significant disease.
- Females who have a positive pregnancy test result, or who are pregnant, breastfeeding,
or planning to conceive during the study.
- History of human immunodeficiency virus (HIV), hepatitis C virus antibody, or
hepatitis B virus.
- History or evidence of drug or alcohol abuse within 2 years prior to Screening.
- Current enrollment in any other study treatment or disease study within 3 months prior
to Day 1/Baseline.
NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/12/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/10/2014
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Sample size
Target
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Accrual to date
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Final
82
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Research Site - Parkville
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Recruitment hospital [2]
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Research Site - Sidney
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Recruitment postcode(s) [1]
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- Parkville
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Recruitment postcode(s) [2]
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- Sidney
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Recruitment outside Australia
Country [1]
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Belgium
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State/province [1]
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Brugge
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Country [2]
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Belgium
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State/province [2]
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Brussels
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Country [3]
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Belgium
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State/province [3]
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Ghent
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Country [4]
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Belgium
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State/province [4]
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Limburg
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Country [5]
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Canada
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State/province [5]
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Halifax
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Country [6]
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Canada
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State/province [6]
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Ottawa
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Country [7]
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Czech Republic
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State/province [7]
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Olomouc
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Country [8]
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Czech Republic
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State/province [8]
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Prague
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Country [9]
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Denmark
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State/province [9]
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Glostrup
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Country [10]
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Germany
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State/province [10]
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Bamberg
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Country [11]
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Germany
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State/province [11]
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Berlin
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Country [12]
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Germany
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State/province [12]
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Dresden
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Country [13]
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Germany
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State/province [13]
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Dusseldorf
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Country [14]
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Germany
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State/province [14]
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Tubingen
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Country [15]
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Hungary
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State/province [15]
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Budapest
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Country [16]
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Italy
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State/province [16]
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Fidenza
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Country [17]
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Italy
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State/province [17]
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Firenze
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Country [18]
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Italy
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State/province [18]
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Milano
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Country [19]
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Italy
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State/province [19]
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Roma
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Country [20]
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Spain
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State/province [20]
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Barcelona
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Country [21]
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Spain
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State/province [21]
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Cordoba
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Country [22]
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Spain
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State/province [22]
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Palmar
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Country [23]
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Spain
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State/province [23]
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Sevilla
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Country [24]
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Spain
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State/province [24]
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Valencia
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Country [25]
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Sweden
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State/province [25]
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Lund
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Country [26]
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Sweden
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State/province [26]
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Stockholm
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Country [27]
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United Kingdom
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State/province [27]
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Birmingham
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Country [28]
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United Kingdom
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State/province [28]
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Glasgow
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Country [29]
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United Kingdom
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State/province [29]
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Leicester
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Country [30]
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United Kingdom
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State/province [30]
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Biogen
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01721161
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Medical Director
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Address
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Biogen
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01721161
Download to PDF