Trial Outcomes & Findings for BIIB033 In Acute Optic Neuritis (AON) (NCT NCT01721161)

Last Updated: 2016-06-30

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

82 participants

Primary outcome timeframe

Baseline, Week 24

Results posted on

2016-06-30

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)	BIIB033 BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
Overall Study STARTED	41	41
Overall Study COMPLETED	37	34
Overall Study NOT COMPLETED	4	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)	BIIB033 BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
Overall Study Adverse Event	2	3
Overall Study Lost to Follow-up	1	2
Overall Study Withdrawal by Subject	1	1
Overall Study Other	0	1

Baseline Characteristics

BIIB033 In Acute Optic Neuritis (AON)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=41 Participants Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)	BIIB033 n=41 Participants BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)	Total n=82 Participants Total of all reporting groups
Age, Continuous	32.4 years STANDARD_DEVIATION 8.85 • n=5 Participants	31.8 years STANDARD_DEVIATION 7.17 • n=7 Participants	32.1 years STANDARD_DEVIATION 8.01 • n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants	27 Participants n=7 Participants	58 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	14 Participants n=7 Participants	24 Participants n=5 Participants
Days from first AON symptom to first dose	24.6 days STANDARD_DEVIATION 3.4 • n=5 Participants	23.6 days STANDARD_DEVIATION 4.0 • n=7 Participants	24.1 days STANDARD_DEVIATION 3.7 • n=5 Participants
Days from confirmed AON diagnosis to first dose	19.2 days STANDARD_DEVIATION 4.9 • n=5 Participants	18.7 days STANDARD_DEVIATION 4.7 • n=7 Participants	19.0 days STANDARD_DEVIATION 4.8 • n=5 Participants
Affected eye Right eye	19 participants n=5 Participants	25 participants n=7 Participants	44 participants n=5 Participants
Affected eye Left eye	22 participants n=5 Participants	16 participants n=7 Participants	38 participants n=5 Participants
Criteria for AON diagnosis Decreased visual acuity	36 participants n=5 Participants	41 participants n=7 Participants	77 participants n=5 Participants
Criteria for AON diagnosis Decreased color vision	30 participants n=5 Participants	33 participants n=7 Participants	63 participants n=5 Participants
Criteria for AON diagnosis Relative afferent pupillary defect	34 participants n=5 Participants	31 participants n=7 Participants	65 participants n=5 Participants
Criteria for AON diagnosis Visual field defect	32 participants n=5 Participants	37 participants n=7 Participants	69 participants n=5 Participants
Criteria for AON diagnosis Ocular pain	31 participants n=5 Participants	36 participants n=7 Participants	67 participants n=5 Participants
Criteria for AON diagnosis Not specified	5 participants n=5 Participants	4 participants n=7 Participants	9 participants n=5 Participants
AON signs and symptoms at screening or baseline Visual field defect	29 participants n=5 Participants	34 participants n=7 Participants	63 participants n=5 Participants
AON signs and symptoms at screening or baseline Color desaturation	33 participants n=5 Participants	32 participants n=7 Participants	65 participants n=5 Participants
AON signs and symptoms at screening or baseline Uhthoff's symptom	8 participants n=5 Participants	18 participants n=7 Participants	26 participants n=5 Participants
AON signs and symptoms at screening or baseline Swollen optic disc	8 participants n=5 Participants	12 participants n=7 Participants	20 participants n=5 Participants
AON signs and symptoms at screening or baseline Relative afferent pupillary defect	33 participants n=5 Participants	30 participants n=7 Participants	63 participants n=5 Participants
FF-VEP conduction block in the affected eye at baseline FF-VEP conduction block	5 participants n=5 Participants	10 participants n=7 Participants	15 participants n=5 Participants
FF-VEP conduction block in the affected eye at baseline No FF-VEP conduction block	36 participants n=5 Participants	31 participants n=7 Participants	67 participants n=5 Participants
FF-VEP latency in the fellow eye at baseline	101.7 ms STANDARD_DEVIATION 5.25 • n=5 Participants	102.7 ms STANDARD_DEVIATION 6.4 • n=7 Participants	102.2 ms STANDARD_DEVIATION 5.8 • n=5 Participants
RGCL/IPL thickness in the affected eye at baseline	66.0 microns STANDARD_DEVIATION 6.9 • n=5 Participants	63.8 microns STANDARD_DEVIATION 7.4 • n=7 Participants	64.8 microns STANDARD_DEVIATION 7.2 • n=5 Participants
Brain Gd+ lesions before first dose	0.5 lesions STANDARD_DEVIATION 1.6 • n=5 Participants	0.2 lesions STANDARD_DEVIATION 1.0 • n=7 Participants	0.4 lesions STANDARD_DEVIATION 1.4 • n=5 Participants
Volume of brain T2 lesions before first dose	1.09 mL STANDARD_DEVIATION 1.32 • n=5 Participants	1.09 mL STANDARD_DEVIATION 1.90 • n=7 Participants	1.09 mL STANDARD_DEVIATION 1.63 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 24

Population: 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.

Outcome measures

Outcome measures
Measure	Placebo n=41 Participants Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)	BIIB033 n=41 Participants BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
Change in Full-field Visual Evoked Potential (FF-VEP) Latency at Week 24: Intent-to-treat (ITT) Population	20.83 msec Standard Error 2.53	17.34 msec Standard Error 2.53

PRIMARY outcome

Timeframe: Baseline, Week 24

Population: 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.

Outcome measures

Outcome measures
Measure	Placebo n=36 Participants Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)	BIIB033 n=33 Participants BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
Change in FF-VEP Latency at Week 24: Per-protocol Population	22.24 msec Standard Error 2.61	14.69 msec Standard Error 2.72

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo n=39 Participants Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)	BIIB033 n=41 Participants BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
Percentage Change in Spectral-domain Optical Coherence Tomography (SD-OCT) Average Retinal Nerve Fiber Layer (RNFL) Thickness at Week 24: ITT Population	-11.77 percentage change Standard Error 2.08	-15.66 percentage change Standard Error 2.03

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: 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.

Outcome measures

Outcome measures
Measure	Placebo n=35 Participants Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)	BIIB033 n=33 Participants BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
Percentage Change in SD-OCT Average RNFL Thickness at Week 24: Per-protocol Population	-12.22 percentage change Standard Error 2.26	-16.98 percentage change Standard Error 2.33

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo n=40 Participants Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)	BIIB033 n=41 Participants BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
Change in SD-OCT Average Retinal Ganglion Cell Layer/Inner Plexiform Retinal Layer (RGCL/IPL) at Week 24: ITT Population	-9.90 µm Standard Deviation 1.20	-11.05 µm Standard Deviation 1.18

SECONDARY outcome

Timeframe: Baseline, Week 24

Outcome measures

Outcome measures
Measure	Placebo n=36 Participants Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)	BIIB033 n=33 Participants BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
Change in SD-OCT Average RGCL/IPL at Week 24: Per-protocol Population	-10.17 µm Standard Deviation 1.29	-11.93 µm Standard Deviation 1.35

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo n=41 Participants Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)	BIIB033 n=39 Participants BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
Change in Low-contrast Letter Acuity (LCLA) at Week 24: ITT Population LCLA 1.25% chart	8.1 letters on a chart Standard Deviation 1.8	6.5 letters on a chart Standard Deviation 1.9
Change in Low-contrast Letter Acuity (LCLA) at Week 24: ITT Population LCLA 2.5% chart	11.9 letters on a chart Standard Deviation 2.0	11.0 letters on a chart Standard Deviation 2.0

SECONDARY outcome

Timeframe: Baseline, Week 24

Outcome measures

Outcome measures
Measure	Placebo n=36 Participants Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)	BIIB033 n=33 Participants BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
Change in LCLA at Week 24: Per-protocol Population LCLA 1.25% chart	7.2 letters on a chart Standard Error 1.8	6.0 letters on a chart Standard Error 2.0
Change in LCLA at Week 24: Per-protocol Population LCLA 2.5% chart	11.6 letters on a chart Standard Error 2.0	10.8 letters on a chart Standard Error 2.2

SECONDARY outcome

Timeframe: 32 weeks

Population: Safety population: all participants who received at least 1 dose of study treatment.

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.

Outcome measures

Outcome measures
Measure	Placebo n=41 Participants Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)	BIIB033 n=41 Participants BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Participants with an event	34 participants	34 participants
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Participants with a moderate or severe event	22 participants	21 participants
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Participants with a severe event	2 participants	3 participants
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Participants with a related event	8 participants	14 participants
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Participants with a serious event	2 participants	5 participants
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Participants with a related serious event	0 participants	3 participants
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Participants discontinuing treatment due to event	1 participants	3 participants
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Participants withdrawing from study due to event	2 participants	3 participants

SECONDARY outcome

Timeframe: Up to 32 weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo n=41 Participants Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)	BIIB033 BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
Summary of BIIB033 Concentration Baseline predose; n=41	0.00 µg/mL Interval 0.0 to 3.22	—
Summary of BIIB033 Concentration Baseline postdose; n=40	2030.00 µg/mL Interval 1370.0 to 3200.0	—
Summary of BIIB033 Concentration Week 4 predose; n=41	375.00 µg/mL Interval 14.6 to 2960.0	—
Summary of BIIB033 Concentration Week 4 postdose; n=37	2350.00 µg/mL Interval 368.0 to 3590.0	—
Summary of BIIB033 Concentration Week 8 predose; n=38	537.00 µg/mL Interval 32.7 to 1130.0	—
Summary of BIIB033 Concentration Week 8 postdose; n=36	2585.00 µg/mL Interval 550.0 to 4220.0	—
Summary of BIIB033 Concentration Week 12 predose; n=36	622.00 µg/mL Interval 39.9 to 3230.0	—
Summary of BIIB033 Concentration Week 12 postdose; n=34	2695.00 µg/mL Interval 542.0 to 4240.0	—
Summary of BIIB033 Concentration Week 16 predose; n=35	593.00 µg/mL Interval 173.0 to 1320.0	—
Summary of BIIB033 Concentration Week 16 postdose; n=34	2500.00 µg/mL Interval 1560.0 to 4590.0	—
Summary of BIIB033 Concentration Week 20 predose; n=37	673.00 µg/mL Interval 107.0 to 4760.0	—
Summary of BIIB033 Concentration Week 20 postdose; n=35	2530.00 µg/mL Interval 366.0 to 3990.0	—
Summary of BIIB033 Concentration Week 24; n=37	624.00 µg/mL Interval 4.3 to 1060.0	—
Summary of BIIB033 Concentration Week 32; n=33	82.70 µg/mL Interval 2.56 to 339.0	—

Adverse Events

Placebo

Serious events: 2 serious events

Other events: 25 other events

Deaths: 0 deaths

BIIB033 100 mg/kg

Serious events: 5 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=41 participants at risk Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)	BIIB033 100 mg/kg n=41 participants at risk BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
Hepatobiliary disorders Liver disorder	0.00% 0/41 • 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.	2.4% 1/41 • 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.
Immune system disorders Hypersensitivity	0.00% 0/41 • 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.	4.9% 2/41 • 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.
Infections and infestations Viral pericarditis	2.4% 1/41 • 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.	0.00% 0/41 • 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.
Investigations Alanine aminotransferase increased	0.00% 0/41 • 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.	2.4% 1/41 • 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.
Investigations Aspartate aminotransferase increased	0.00% 0/41 • 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.	2.4% 1/41 • 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.
Investigations Cytomegalovirus test positive	2.4% 1/41 • 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.	0.00% 0/41 • 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.
Nervous system disorders Multiple sclerosis	2.4% 1/41 • 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.	0.00% 0/41 • 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.
Nervous system disorders Multiple sclerosis relapse	0.00% 0/41 • 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.	2.4% 1/41 • 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.
Nervous system disorders Optic neuritis	0.00% 0/41 • 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.	2.4% 1/41 • 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.

Other adverse events

Other adverse events
Measure	Placebo n=41 participants at risk Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)	BIIB033 100 mg/kg n=41 participants at risk BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
Eye disorders Colour blindness acquired	4.9% 2/41 • 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.	7.3% 3/41 • 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.
Gastrointestinal disorders Nausea	7.3% 3/41 • 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.	12.2% 5/41 • 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.
General disorders Fatigue	12.2% 5/41 • 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.	14.6% 6/41 • 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.
Infections and infestations Influenza	7.3% 3/41 • 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.	4.9% 2/41 • 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.
Infections and infestations Nasopharyngitis	31.7% 13/41 • 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.	29.3% 12/41 • 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.
Infections and infestations Upper respiratory tract infection	4.9% 2/41 • 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.	7.3% 3/41 • 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.
Musculoskeletal and connective tissue disorders Back pain	2.4% 1/41 • 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.	7.3% 3/41 • 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.
Nervous system disorders Dysaesthesia	4.9% 2/41 • 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.	7.3% 3/41 • 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.
Nervous system disorders Headache	26.8% 11/41 • 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.	26.8% 11/41 • 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.
Nervous system disorders Multiple sclerosis	7.3% 3/41 • 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.	2.4% 1/41 • 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.
Nervous system disorders Paraesthesia	0.00% 0/41 • 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.	9.8% 4/41 • 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.
Nervous system disorders Uhthoff's phenomenon	14.6% 6/41 • 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.	7.3% 3/41 • 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.
Nervous system disorders Visual field defect	0.00% 0/41 • 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.	7.3% 3/41 • 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.

Additional Information

Biogen Study Medical Director

Biogen

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
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Restriction type: OTHER