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BIIB033 In Acute Optic Neuritis (AON)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01721161
Recruitment Status : Completed
First Posted : November 4, 2012
Results First Posted : June 30, 2016
Last Update Posted : June 30, 2016
Sponsor:
Information provided by (Responsible Party):
Biogen

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Acute Optic Neuritis
Interventions Biological: BIIB033 (anti-LINGO-1 mAb)
Drug: Placebo
Enrollment 82
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo BIIB033
Hide Arm/Group Description Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses) BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
Period Title: Overall Study
Started 41 41
Completed 37 34
Not Completed 4 7
Reason Not Completed
Adverse Event             2             3
Lost to Follow-up             1             2
Withdrawal by Subject             1             1
Other             0             1
Arm/Group Title Placebo BIIB033 Total
Hide Arm/Group Description Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses) BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses) Total of all reporting groups
Overall Number of Baseline Participants 41 41 82
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 41 participants 41 participants 82 participants
32.4  (8.85) 31.8  (7.17) 32.1  (8.01)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 41 participants 82 participants
Female
31
  75.6%
27
  65.9%
58
  70.7%
Male
10
  24.4%
14
  34.1%
24
  29.3%
Days from first AON symptom to first dose   [1] 
Mean (Standard Deviation)
Unit of measure:  Days
Number Analyzed 41 participants 41 participants 82 participants
24.6  (3.4) 23.6  (4.0) 24.1  (3.7)
[1]
Measure Description: First dose given, on average, 2 weeks after completion of high-dose (1 g daily for 3 to 5 days) IV methylprednisolone treatment.
Days from confirmed AON diagnosis to first dose  
Mean (Standard Deviation)
Unit of measure:  Days
Number Analyzed 41 participants 41 participants 82 participants
19.2  (4.9) 18.7  (4.7) 19.0  (4.8)
Affected eye  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 41 participants 41 participants 82 participants
Right eye 19 25 44
Left eye 22 16 38
Criteria for AON diagnosis  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 41 participants 41 participants 82 participants
Decreased visual acuity 36 41 77
Decreased color vision 30 33 63
Relative afferent pupillary defect 34 31 65
Visual field defect 32 37 69
Ocular pain 31 36 67
Not specified 5 4 9
AON signs and symptoms at screening or baseline   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 41 participants 41 participants 82 participants
Visual field defect 29 34 63
Color desaturation 33 32 65
Uhthoff's symptom 8 18 26
Swollen optic disc 8 12 20
Relative afferent pupillary defect 33 30 63
[1]
Measure Description: Symptoms were not uniformly tested in accordance with a predefined protocol.
FF-VEP conduction block in the affected eye at baseline   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 41 participants 41 participants 82 participants
FF-VEP conduction block 5 10 15
No FF-VEP conduction block 36 31 67
[1]
Measure Description: FF-VEP=full-field visual evoked potentials
FF-VEP latency in the fellow eye at baseline  
Mean (Standard Deviation)
Unit of measure:  Ms
Number Analyzed 41 participants 41 participants 82 participants
101.7  (5.25) 102.7  (6.4) 102.2  (5.8)
RGCL/IPL thickness in the affected eye at baseline   [1] 
Mean (Standard Deviation)
Unit of measure:  Microns
Number Analyzed 41 participants 41 participants 82 participants
66.0  (6.9) 63.8  (7.4) 64.8  (7.2)
[1]
Measure Description: RGCL/IPL=retinal ganglion cell layer/inner plexiform retinal layer. n=38 in the placebo group and n=40 in the anti-LINGO-1 group, total n=78.
Brain Gd+ lesions before first dose   [1] 
Mean (Standard Deviation)
Unit of measure:  Lesions
Number Analyzed 41 participants 41 participants 82 participants
0.5  (1.6) 0.2  (1.0) 0.4  (1.4)
[1]
Measure Description: Gd+=gadolinium-enhancing. n=38 in each group, total n=76.
Volume of brain T2 lesions before first dose   [1] 
Mean (Standard Deviation)
Unit of measure:  mL
Number Analyzed 41 participants 41 participants 82 participants
1.09  (1.32) 1.09  (1.90) 1.09  (1.63)
[1]
Measure Description: n=38 in each group, total n=76.
1.Primary Outcome
Title Change in Full-field Visual Evoked Potential (FF-VEP) Latency at Week 24: Intent-to-treat (ITT) Population
Hide Description 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.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: all randomized subjects who received at least 1 dose of study treatment (BIIB033 or placebo). Last observation carried forward (LOCF) imputation was used if Week 24 data were missing.
Arm/Group Title Placebo BIIB033
Hide Arm/Group Description:
Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
Overall Number of Participants Analyzed 41 41
Mean (Standard Error)
Unit of Measure: msec
20.83  (2.53) 17.34  (2.53)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, BIIB033
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3337
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value -3.48
Confidence Interval (2-Sided) 95%
-10.61 to 3.65
Estimation Comments Difference is calculated as BIIB033 100 mg/kg - placebo.
2.Primary Outcome
Title Change in FF-VEP Latency at Week 24: Per-protocol Population
Hide Description 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.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol Population: participants from the ITT population who completed the study, did not miss more than 1 dose of BIIB033 or placebo, and did not receive multiple sclerosis (MS)-modifying therapies during the study period, which were prohibited per protocol. LOCF imputation was used if Week 24 data were missing.
Arm/Group Title Placebo BIIB033
Hide Arm/Group Description:
Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
Overall Number of Participants Analyzed 36 33
Mean (Standard Error)
Unit of Measure: msec
22.24  (2.61) 14.69  (2.72)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, BIIB033
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0504
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value -7.55
Confidence Interval (2-Sided) 95%
-15.12 to 0.01
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage Change in Spectral-domain Optical Coherence Tomography (SD-OCT) Average Retinal Nerve Fiber Layer (RNFL) Thickness at Week 24: ITT Population
Hide Description 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.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: all randomized subjects who received at least 1 dose of study treatment (BIIB033 or placebo) and a valid RNFL assessment at Baseline. LOCF imputation was used if Week 24 data were missing.
Arm/Group Title Placebo BIIB033
Hide Arm/Group Description:
Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
Overall Number of Participants Analyzed 39 41
Mean (Standard Error)
Unit of Measure: percentage change
-11.77  (2.08) -15.66  (2.03)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, BIIB033
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1868
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value -3.89
Confidence Interval (2-Sided) 95%
-9.70 to 1.92
Estimation Comments Difference is calculated as BIIB033 100 mg/kg - placebo.
4.Secondary Outcome
Title Percentage Change in SD-OCT Average RNFL Thickness at Week 24: Per-protocol Population
Hide Description 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.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol Population: participants from the ITT population who completed the study, did not miss more than 1 dose of BIIB033 or placebo, and did not receive MS-modifying therapies during the study period, which were prohibited per protocol. LOCF imputation was used if Week 24 data were missing.
Arm/Group Title Placebo BIIB033
Hide Arm/Group Description:
Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
Overall Number of Participants Analyzed 35 33
Mean (Standard Error)
Unit of Measure: percentage change
-12.22  (2.26) -16.98  (2.33)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, BIIB033
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1488
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value -4.76
Confidence Interval (2-Sided) 95%
-11.26 to 1.74
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change in SD-OCT Average Retinal Ganglion Cell Layer/Inner Plexiform Retinal Layer (RGCL/IPL) at Week 24: ITT Population
Hide Description 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.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: all randomized subjects who received at least 1 dose of study treatment (BIIB033 or placebo) with a valid RGCL/IPL assessment at Baseline. LOCF imputation was used if Week 24 data were missing.
Arm/Group Title Placebo BIIB033
Hide Arm/Group Description:
Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
Overall Number of Participants Analyzed 40 41
Mean (Standard Deviation)
Unit of Measure: µm
-9.90  (1.20) -11.05  (1.18)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, BIIB033
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4975
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value -1.15
Confidence Interval (2-Sided) 95%
-4.51 to 2.21
Estimation Comments Difference is calculated as BIIB033 100 mg/kg - placebo.
6.Secondary Outcome
Title Change in SD-OCT Average RGCL/IPL at Week 24: Per-protocol Population
Hide Description 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.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol Population: participants from the ITT population who completed the study, did not miss more than 1 dose of BIIB033 or placebo, and did not receive MS-modifying therapies during the study period, which were prohibited per protocol. LOCF imputation was used if Week 24 data were missing.
Arm/Group Title Placebo BIIB033
Hide Arm/Group Description:
Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
Overall Number of Participants Analyzed 36 33
Mean (Standard Deviation)
Unit of Measure: µm
-10.17  (1.29) -11.93  (1.35)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, BIIB033
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3505
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value -1.76
Confidence Interval (2-Sided) 95%
-5.50 to 1.98
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change in Low-contrast Letter Acuity (LCLA) at Week 24: ITT Population
Hide Description 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.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: all randomized subjects who received at least 1 dose of study treatment (BIIB033 or placebo) with an LCLA assessment at Baseline. LOCF imputation was used if Week 24 data were missing.
Arm/Group Title Placebo BIIB033
Hide Arm/Group Description:
Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
Overall Number of Participants Analyzed 41 39
Mean (Standard Deviation)
Unit of Measure: letters on a chart
LCLA 1.25% chart 8.1  (1.8) 6.5  (1.9)
LCLA 2.5% chart 11.9  (2.0) 11.0  (2.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, BIIB033
Comments LCLA 1.25% chart
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5371
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value -1.6
Confidence Interval (2-Sided) 95%
-6.9 to 3.6
Estimation Comments Difference is calculated as BIIB033 100 mg/kg - placebo.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, BIIB033
Comments LCLA 2.5% chart
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7741
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value -0.8
Confidence Interval (2-Sided) 95%
-6.5 to 4.9
Estimation Comments Difference is calculated as BIIB033 100 mg/kg - placebo.
8.Secondary Outcome
Title Change in LCLA at Week 24: Per-protocol Population
Hide Description 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.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol Population: participants from the ITT population who completed the study, did not miss more than 1 dose of BIIB033 or placebo, and did not receive MS-modifying therapies during the study period, which were prohibited per protocol. LOCF imputation was used if Week 24 data were missing.
Arm/Group Title Placebo BIIB033
Hide Arm/Group Description:
Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
Overall Number of Participants Analyzed 36 33
Mean (Standard Error)
Unit of Measure: letters on a chart
LCLA 1.25% chart 7.2  (1.8) 6.0  (2.0)
LCLA 2.5% chart 11.6  (2.0) 10.8  (2.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, BIIB033
Comments LCLA 1.25% chart
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6645
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value -1.2
Confidence Interval (2-Sided) 95%
-6.6 to 4.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, BIIB033
Comments LCLA 2.5%
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8015
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter DIfference
Estimated Value -0.8
Confidence Interval (2-Sided) 95%
-6.7 to 5.2
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description 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.
Time Frame 32 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population: all participants who received at least 1 dose of study treatment.
Arm/Group Title Placebo BIIB033
Hide Arm/Group Description:
Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
Overall Number of Participants Analyzed 41 41
Measure Type: Number
Unit of Measure: participants
Participants with an event 34 34
Participants with a moderate or severe event 22 21
Participants with a severe event 2 3
Participants with a related event 8 14
Participants with a serious event 2 5
Participants with a related serious event 0 3
Participants discontinuing treatment due to event 1 3
Participants withdrawing from study due to event 2 3
10.Secondary Outcome
Title Summary of BIIB033 Concentration
Hide Description 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.
Time Frame Up to 32 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis population: all participants who received at least 1 dose of BIIB033 and had at least 1 serum concentration data on record. n=number of participants with a sample at given timepoint.
Arm/Group Title BIIB033
Hide Arm/Group Description:
BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
Overall Number of Participants Analyzed 41
Median (Full Range)
Unit of Measure: µg/mL
Baseline predose; n=41
0.00
(0.00 to 3.22)
Baseline postdose; n=40
2030.00
(1370.00 to 3200.00)
Week 4 predose; n=41
375.00
(14.60 to 2960.00)
Week 4 postdose; n=37
2350.00
(368.00 to 3590.00)
Week 8 predose; n=38
537.00
(32.70 to 1130.00)
Week 8 postdose; n=36
2585.00
(550.00 to 4220.00)
Week 12 predose; n=36
622.00
(39.90 to 3230.00)
Week 12 postdose; n=34
2695.00
(542.00 to 4240.00)
Week 16 predose; n=35
593.00
(173.00 to 1320.00)
Week 16 postdose; n=34
2500.00
(1560.00 to 4590.00)
Week 20 predose; n=37
673.00
(107.00 to 4760.00)
Week 20 postdose; n=35
2530.00
(366.00 to 3990.00)
Week 24; n=37
624.00
(4.30 to 1060.00)
Week 32; n=33
82.70
(2.56 to 339.00)
Time Frame AEs were monitored from administration of first dose of study treatment through to Week 32 visit. SAEs were monitored from signing of the Informed Consent Form (ICF) through to Week 32 visit.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo BIIB033 100 mg/kg
Hide Arm/Group Description Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses) BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
All-Cause Mortality
Placebo BIIB033 100 mg/kg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Placebo BIIB033 100 mg/kg
Affected / at Risk (%) Affected / at Risk (%)
Total   2/41 (4.88%)   5/41 (12.20%) 
Hepatobiliary disorders     
Liver disorder  1  0/41 (0.00%)  1/41 (2.44%) 
Immune system disorders     
Hypersensitivity  1  0/41 (0.00%)  2/41 (4.88%) 
Infections and infestations     
Viral pericarditis  1  1/41 (2.44%)  0/41 (0.00%) 
Investigations     
Alanine aminotransferase increased  1  0/41 (0.00%)  1/41 (2.44%) 
Aspartate aminotransferase increased  1  0/41 (0.00%)  1/41 (2.44%) 
Cytomegalovirus test positive  1  1/41 (2.44%)  0/41 (0.00%) 
Nervous system disorders     
Multiple sclerosis  1  1/41 (2.44%)  0/41 (0.00%) 
Multiple sclerosis relapse  1  0/41 (0.00%)  1/41 (2.44%) 
Optic neuritis  1  0/41 (0.00%)  1/41 (2.44%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo BIIB033 100 mg/kg
Affected / at Risk (%) Affected / at Risk (%)
Total   25/41 (60.98%)   27/41 (65.85%) 
Eye disorders     
Colour blindness acquired  1  2/41 (4.88%)  3/41 (7.32%) 
Gastrointestinal disorders     
Nausea  1  3/41 (7.32%)  5/41 (12.20%) 
General disorders     
Fatigue  1  5/41 (12.20%)  6/41 (14.63%) 
Infections and infestations     
Influenza  1  3/41 (7.32%)  2/41 (4.88%) 
Nasopharyngitis  1  13/41 (31.71%)  12/41 (29.27%) 
Upper respiratory tract infection  1  2/41 (4.88%)  3/41 (7.32%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  1/41 (2.44%)  3/41 (7.32%) 
Nervous system disorders     
Dysaesthesia  1  2/41 (4.88%)  3/41 (7.32%) 
Headache  1  11/41 (26.83%)  11/41 (26.83%) 
Multiple sclerosis  1  3/41 (7.32%)  1/41 (2.44%) 
Paraesthesia  1  0/41 (0.00%)  4/41 (9.76%) 
Uhthoff's phenomenon  1  6/41 (14.63%)  3/41 (7.32%) 
Visual field defect  1  0/41 (0.00%)  3/41 (7.32%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Biogen Study Medical Director
Organization: Biogen
EMail: clinicaltrials@biogen.com
Layout table for additonal information
Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT01721161    
Other Study ID Numbers: 215ON201
First Submitted: October 25, 2012
First Posted: November 4, 2012
Results First Submitted: May 24, 2016
Results First Posted: June 30, 2016
Last Update Posted: June 30, 2016