Safety, Tolerability and Activity Study of Ibudilast in Subjects With Progressive Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT01982942

Recruitment Status : Completed

First Posted : November 13, 2013

Results First Posted : July 28, 2020

Last Update Posted : July 28, 2020

Sponsor:

Collaborators:

National Institutes of Health (NIH)

National Institute of Neurological Disorders and Stroke (NINDS)

National Multiple Sclerosis Society

Information provided by (Responsible Party):

MediciNova

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
Conditions	Multiple Sclerosis, Primary Progressive Multiple Sclerosis, Secondary Progressive
Interventions	Drug: ibudilast Drug: Placebo oral capsule
Enrollment	255

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Ibudilast	Placebo Oral Capsule
Arm/Group Description	Subjects will receive up to 100 mg/...	Subjects will receive placebo for 9...
Arm/Group Description	Subjects will receive up to 100 mg/d ibudilast for 96 weeks. ibudilast: Subjects randomly assigned to the ibudilast (MN-166) cohort will receive up to 100 mg/day for 96 weeks.	Subjects will receive placebo for 96 weeks. Placebo oral capsule: Subjects randomly assigned to the placebo cohort will receive placebo oral capsule for 96 weeks.
Period Title: Overall Study
Started	129	126
Completed	108	112
Not Completed	21	14
Reason Not Completed
Adverse Event	10	5
Lost to Follow-up	4	3
Multiple sclerosis progression	3	2
Wanted to try therapy not permitted	1	0
Subject declined future visits	0	1
Left geographical area	2	0
Too many pills	1	0
MS Relapse	0	1
Chose to join a stem cell trial	0	1
Subject bedridden, rapidly declining	0	1

Baseline Characteristics

Arm/Group Title		Ibudilast	Placebo Oral Capsule	Total
Arm/Group Description		Subjects will receive up to 100 mg/...	Subjects will receive placebo for 9...	Total of all reporting groups
Arm/Group Description		Subjects will receive up to 100 mg/d ibudilast for 96 weeks. ibudilast: Subjects randomly assigned to the ibudilast (MN-166) cohort will receive up to 100 mg/day for 96 weeks.	Subjects will receive placebo for 96 weeks. Placebo oral capsule: Subjects randomly assigned to the placebo cohort will receive placebo oral capsule for 96 weeks.	Total of all reporting groups
Overall Number of Baseline Participants		129	126	255
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Customized Mean (Standard Deviation) Unit of measure: Years
Age (years)	Number Analyzed	129 participants	126 participants	255 participants
Age (years)		54.0 (7.8)	56.1 (6.6)	56.0 (7.3)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	129 participants	126 participants	255 participants
	Female	67 51.9%	69 54.8%	136 53.3%
	Male	62 48.1%	57 45.2%	119 46.7%
Ethnicity (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	129 participants	126 participants	255 participants
	Hispanic or Latino	4 3.1%	3 2.4%	7 2.7%
	Not Hispanic or Latino	125 96.9%	121 96.0%	246 96.5%
	Unknown or Not Reported	0 0.0%	2 1.6%	2 0.8%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	129 participants	126 participants	255 participants
	American Indian or Alaska Native	1 0.8%	0 0.0%	1 0.4%
	Asian	0 0.0%	0 0.0%	0 0.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	4 3.1%	7 5.6%	11 4.3%
	White	122 94.6%	114 90.5%	236 92.5%
	More than one race	2 1.6%	1 0.8%	3 1.2%
	Unknown or Not Reported	0 0.0%	4 3.2%	4 1.6%
Region of Enrollment Measure Type: Number Unit of measure: Participants
United States	Number Analyzed	129 participants	126 participants	255 participants
United States		129	126	255

Outcome Measures

1.Primary Outcome


Title	Covariate-adjusted Mean Rate of Change in Brain Atrophy Over 96 Weeks as Measured by Brain Parenchymal Fraction (BPF).
Description	To evaluate the activity of ibudilast (100 mg/day) versus placebo at 9...
Description	To evaluate the activity of ibudilast (100 mg/day) versus placebo at 96 weeks as measured by quantitative magnetic resonance imaging (MRI) analysis for whole brain atrophy using brain parenchymal fraction (BPF), calculated as the ratio of brain parenchymal tissue volume to the total volume contained within the brain surface contour.
Time Frame	96 weeks

Outcome Measure Data

Analysis Population Description

Modified intent-to-treat is the primary population for efficacy analysis, defined as all participants from the intent-to-treat population (all participants randomly assigned) who received at least one dose of study medication, have at least one efficacy assessment for at least one primary or secondary parameter in the double-blind treatment phase.


Arm/Group Title	Ibudilast	Placebo Oral Capsule
Arm/Group Description:	Subjects will receive up to 100 mg/...	Subjects will receive placebo for 9...
Arm/Group Description:	Subjects will receive up to 100 mg/d ibudilast for 96 weeks. ibudilast: Subjects randomly assigned to the ibudilast (MN-166) cohort will receive up to 100 mg/day for 96 weeks.	Subjects will receive placebo for 96 weeks. Placebo oral capsule: Subjects randomly assigned to the placebo cohort will receive placebo oral capsule for 96 weeks.
Overall Number of Participants Analyzed	103	111
Mean (90% Confidence Interval) Unit of Measure: ratio
	-0.00168 (-0.00288 to -0.00048)	-0.00392 (-0.00491 to -0.00293)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ibudilast, Placebo Oral Capsule
	Comments	The null hypothesis states that the BPF rates of change in the treatment and placebo groups are equal, which can be evaluated based on as assessment of parameter estimates from a linear mixed model (LMM).
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.04
	Comments	[Not Specified]
	Method	t-test, 2 sided
	Comments	[Not Specified]

2.Primary Outcome


Title	Percentage of Participants With Adverse Events.
Description	Safety Measures: percentage of participants who experienced treatment-...
Description	Safety Measures: percentage of participants who experienced treatment-emergent adverse events, clinically significant abnormal laboratory and electrocardiogram results.
Time Frame	96 weeks

Outcome Measure Data

Analysis Population Description

Safety analysis population: comprises all subjects who received at least one dose of study medication. This is the population for all safety analyses, and subjects were analyzed based on the treatment they received.


Arm/Group Title	Ibudilast	Placebo Oral Capsule
Arm/Group Description:	Subjects will receive up to 100 mg/...	Subjects will receive placebo for 9...
Arm/Group Description:	Subjects will receive up to 100 mg/d ibudilast for 96 weeks. ibudilast: Subjects randomly assigned to the ibudilast (MN-166) cohort will receive up to 100 mg/day for 96 weeks.	Subjects will receive placebo for 96 weeks. Placebo oral capsule: Subjects randomly assigned to the placebo cohort will receive placebo oral capsule for 96 weeks.
Overall Number of Participants Analyzed	129	126
Measure Type: Number Number (90% Confidence Interval) Unit of Measure: percentage receiving study medication
	92.2 (87.2 to 95.7)	88.1 (82.3 to 92.5)

3.Secondary Outcome


Title	Diffusion Tensor Imaging (DTI) in Descending Pyramidal White Matter Tracts
Description	Diffusion tensor imaging estimates the three-dimensional diffusion of ...
Description	Diffusion tensor imaging estimates the three-dimensional diffusion of water in brain tissue and has been explored as an outcome in MS.
Time Frame	48 weeks

Outcome Measure Data

Analysis Population Description

modified intent-to-treat population


Arm/Group Title	Ibudilast	Placebo Oral Capsule
Arm/Group Description:	Subjects will receive up to 100 mg/...	Subjects will receive placebo for 9...
Arm/Group Description:	Subjects will receive up to 100 mg/d ibudilast for 96 weeks. ibudilast: Subjects randomly assigned to the ibudilast (MN-166) cohort will receive up to 100 mg/day for 96 weeks.	Subjects will receive placebo for 96 weeks. Placebo oral capsule: Subjects randomly assigned to the placebo cohort will receive placebo oral capsule for 96 weeks.
Overall Number of Participants Analyzed	103	111
Least Squares Mean (90% Confidence Interval) Unit of Measure: 10^3/mm^2/s
Left axial diffusivity mean	0.0001 (-0.0068 to 0.0070)	-0.0006 (-0.0074 to 0.0061)
Left radial diffusivity mean	-0.0077 (-0.0131 to -0.0023)	0.0027 (-0.0026 to 0.0081)
Right axial diffusivity mean	0.0014 (-0.0055 to 0.0084)	-0.0017 (-0.0085 to 0.0051)
Right radial diffusivity mean	-0.0029 (-0.0088 to 0.0031)	0.0046 (-0.0012 to 0.0104)

4.Secondary Outcome


Title	Magnetization Transfer Ratio (MTR) Imaging in Normal-appearing Brain Tissue
Description	A magnetization transfer MRI as a marker of brain myelin content inclu...
Description	A magnetization transfer MRI as a marker of brain myelin content including the cerebral cortex could be useful. MT imaging provides access to the restricted protons, which are located in biologically interesting tissue regions.Cortical and normal appearing grey matter MTR correlates strongly with measures of disability such as the multiple sclerosis functional composite score and can show treatment effects.
Time Frame	96 weeks

Outcome Measure Data

Analysis Population Description


Arm/Group Title	Ibudilast	Placebo Oral Capsule
Arm/Group Description:	Subjects will receive up to 100 mg/...	Subjects will receive placebo for 9...
Arm/Group Description:	Subjects will receive up to 100 mg/d ibudilast for 96 weeks. ibudilast: Subjects randomly assigned to the ibudilast (MN-166) cohort will receive up to 100 mg/day for 96 weeks.	Subjects will receive placebo for 96 weeks. Placebo oral capsule: Subjects randomly assigned to the placebo cohort will receive placebo oral capsule for 96 weeks.
Overall Number of Participants Analyzed	95	103
Least Squares Mean (90% Confidence Interval) Unit of Measure: ratio
	0.325 (0.285 to 0.365)	0.247 (0.195 to 0.299)

5.Secondary Outcome


Title	Retinal Nerve Fiber Layer as Measured by Optical Coherence Tomography (OCT).
Description	Mean retinal nerve fiber layer thickness from baseline measured by Opt...
Description	Mean retinal nerve fiber layer thickness from baseline measured by Optical coherence tomography (OCT), a non-invasive imaging technique used to obtain high-resolution cross-sectional images of the retina. Increase in thickness is considered improvement.
Time Frame	96 weeks

Outcome Measure Data

Analysis Population Description


Arm/Group Title	Ibudilast	Placebo Oral Capsule
Arm/Group Description:	Subjects will receive up to 100 mg/...	Subjects will receive placebo for 9...
Arm/Group Description:	Subjects will receive up to 100 mg/d ibudilast for 96 weeks. ibudilast: Subjects randomly assigned to the ibudilast (MN-166) cohort will receive up to 100 mg/day for 96 weeks.	Subjects will receive placebo for 96 weeks. Placebo oral capsule: Subjects randomly assigned to the placebo cohort will receive placebo oral capsule for 96 weeks.
Overall Number of Participants Analyzed	94	103
Least Squares Mean (90% Confidence Interval) Unit of Measure: micrometers
	83.0 (80.7 to 85.2)	79.5 (77.2 to 81.7)

6.Other Pre-specified Outcome


Title	New T1 Lesions Since Baseline
Description	New T1 lesions since baseline as measured by least square mean (90% co...
Description	New T1 lesions since baseline as measured by least square mean (90% confidence interval).
Time Frame	96 weeks

Outcome Measure Data

Analysis Population Description


Arm/Group Title	Ibudilast	Placebo Oral Capsule
Arm/Group Description:	Subjects will receive up to 100 mg/...	Subjects will receive placebo for 9...
Arm/Group Description:	Subjects will receive up to 100 mg/d ibudilast for 96 weeks. ibudilast: Subjects randomly assigned to the ibudilast (MN-166) cohort will receive up to 100 mg/day for 96 weeks.	Subjects will receive placebo for 96 weeks. Placebo oral capsule: Subjects randomly assigned to the placebo cohort will receive placebo oral capsule for 96 weeks.
Overall Number of Participants Analyzed	102	110
Least Squares Mean (90% Confidence Interval) Unit of Measure: lesions
	0.355 (0.202 to 0.507)	0.317 (0.170 to 0.463)

Adverse Events

Time Frame	100 weeks
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	Ibudilast		Placebo Oral Capsule
Arm/Group Description	Subjects will receive up to 100 mg/...		Subjects will receive placebo for 9...
Arm/Group Description	Subjects will receive up to 100 mg/d ibudilast for 96 weeks. ibudilast: Subjects randomly assigned to the ibudilast (MN-166) cohort will receive up to 100 mg/day for 96 weeks.		Subjects will receive placebo for 96 weeks. Placebo oral capsule: Subjects randomly assigned to the placebo cohort will receive placebo oral capsule for 96 weeks.
All-Cause Mortality
	Ibudilast		Placebo Oral Capsule
	Affected / at Risk (%)		Affected / at Risk (%)
Total	0/129 (0.00%)		0/126 (0.00%)
Serious Adverse Events Serious Adverse Events
	Ibudilast		Placebo Oral Capsule
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	20/129 (15.50%)		24/126 (19.05%)
Blood and lymphatic system disorders
thrombocytopenia ^† 1	0/129 (0.00%)	0	1/126 (0.79%)	1
Cardiac disorders
myocardial infarction ^† 1	1/129 (0.78%)	1	0/126 (0.00%)	0
atrial fibrillation ^† 1	0/129 (0.00%)	0	1/126 (0.79%)	1
Endocrine disorders
parotidectomy ^† 1	0/129 (0.00%)	0	1/126 (0.79%)	1
Gastrointestinal disorders
colonic obstruction ^† 1	0/129 (0.00%)	0	1/126 (0.79%)	1
intestinal obstraction ^† 1	0/129 (0.00%)	0	1/126 (0.79%)	1
General disorders
Pain ^† 1	2/129 (1.55%)	2	0/126 (0.00%)	0
Asthenia ^† 1	1/129 (0.78%)	1	0/126 (0.00%)	0
Hepatobiliary disorders
febrile neutropenia ^† 1	1/129 (0.78%)	1	0/126 (0.00%)	0
colelithiais ^† 1	0/129 (0.00%)	0	1/126 (0.79%)	1
Infections and infestations
cystitis ^† 1	0/129 (0.00%)	0	1/126 (0.79%)	1
urinary tract infection ^† 1	2/129 (1.55%)	2	1/126 (0.79%)	1
sepsis ^† 1	1/129 (0.78%)	1	1/126 (0.79%)	1
tooth infection ^† 1	0/129 (0.00%)	0	1/126 (0.79%)	1
Metabolism and nutrition disorders
dehydration ^† 1	1/129 (0.78%)	1	0/126 (0.00%)	0
hypercalcemia ^† 1	1/129 (0.78%)	1	0/126 (0.00%)	0
hypokalemia ^† 1	1/129 (0.78%)	1	0/126 (0.00%)	0
hyponatremia ^† 1	0/129 (0.00%)	0	1/126 (0.79%)	1
Musculoskeletal and connective tissue disorders
rotator cuff syndrome ^† 1	1/129 (0.78%)	1	0/126 (0.00%)	0
fracture ^† 1	2/129 (1.55%)	2	1/126 (0.79%)	1
back pain ^† 1	1/129 (0.78%)	1	1/126 (0.79%)	1
muscular weakness ^† 1	0/129 (0.00%)	0	1/126 (0.79%)	1
cervical spinal stenosis ^† 1	0/129 (0.00%)	0	1/126 (0.79%)	1
injury ^† 1	0/129 (0.00%)	0	1/126 (0.79%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
cervix carcinoma stage 0 ^† 1	1/129 (0.78%)	1	0/126 (0.00%)	0
metastatic malignant melanoma ^† 1	1/129 (0.78%)	1	0/126 (0.00%)	0
endometrial cancer ^† 1	0/129 (0.00%)	0	1/126 (0.79%)	1
breast cancer ^† 1	0/129 (0.00%)	0	1/126 (0.79%)	1
bladder transitional cell cancer ^† 1	0/129 (0.00%)	0	1/126 (0.79%)	1
Nervous system disorders
ataxia ^† 1	1/129 (0.78%)	1	0/126 (0.00%)	0
cerebral haemorrhage ^† 1	1/129 (0.78%)	1	0/126 (0.00%)	0
spondylitic myelopathy ^† 1	1/129 (0.78%)	1	0/126 (0.00%)	0
cerebrovascular accident ^† 1	0/129 (0.00%)	0	1/126 (0.79%)	1
convulsion ^† 1	0/129 (0.00%)	0	1/126 (0.79%)	1
Renal and urinary disorders
bladder prolapse ^† 1	0/129 (0.00%)	0	1/126 (0.79%)	1
kideny infection ^† 1	0/129 (0.00%)	0	1/126 (0.79%)	1
Respiratory, thoracic and mediastinal disorders
pulmonary embolism ^† 1	0/129 (0.00%)	0	1/126 (0.79%)	1
1 Term from vocabulary, MedDRA (Unspecified) † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	2%
	Ibudilast		Placebo Oral Capsule
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	119/129 (92.25%)		111/126 (88.10%)
Cardiac disorders
Bradycardia ^* 1	3/129 (2.33%)	3	1/126 (0.79%)	1
Atrioventricular block first degree ^* 1	1/129 (0.78%)	1	4/126 (3.17%)	7
Atrial fibrillation ^* 1	0/129 (0.00%)	0	3/126 (2.38%)	3
Ear and labyrinth disorders
Vertigo ^* 1	2/129 (1.55%)	3	3/126 (2.38%)	3
Eye disorders
Conjunctivitis ^* 1	3/129 (2.33%)	3	2/126 (1.59%)	2
Gastrointestinal disorders
Nausea ^* 1	35/129 (27.13%)	39	19/126 (15.08%)	21
Diarrhoea ^* 1	19/129 (14.73%)	21	8/126 (6.35%)	9
Vomiting ^* 1	9/129 (6.98%)	10	3/126 (2.38%)	3
Constipation ^* 1	8/129 (6.20%)	10	7/126 (5.56%)	7
Abdominal pain ^* 1	6/129 (4.65%)	7	0/126 (0.00%)	0
Dyspepsia ^* 1	5/129 (3.88%)	5	3/126 (2.38%)	6
Abdominal pain upper ^* 1	5/129 (3.88%)	5	0/126 (0.00%)	0
Abdominal distension ^* 1	2/129 (1.55%)	2	1/126 (0.79%)	3
Gastro-oesophageal reflux disease ^* 1	4/129 (3.10%)	4	2/126 (1.59%)	2
Flatulence ^* 1	2/129 (1.55%)	2	6/126 (4.76%)	6
Dysphagia ^* 1	2/129 (1.55%)	2	5/126 (3.97%)	5
General disorders
Fatigue ^* 1	14/129 (10.85%)	14	10/126 (7.94%)	11
Oedema peripheral ^* 1	5/129 (3.88%)	6	6/126 (4.76%)	6
Irritability ^* 1	3/129 (2.33%)	3	0/126 (0.00%)	0
Chest pain ^* 1	1/129 (0.78%)	1	3/126 (2.38%)	3
Influenza like illness ^* 1	1/129 (0.78%)	1	3/126 (2.38%)	3
Infections and infestations
Urinary tract infection ^* 1	35/129 (27.13%)	67	43/126 (34.13%)	88
Upper respiratory tract infection ^* 1	13/129 (10.08%)	17	24/126 (19.05%)	26
Sinusitis ^* 1	5/129 (3.88%)	7	6/126 (4.76%)	7
Bronchitis ^* 1	5/129 (3.88%)	5	4/126 (3.17%)	5
Nasopharyngitis ^* 1	5/129 (3.88%)	6	3/126 (2.38%)	4
Gastroenteritis ^* 1	3/129 (2.33%)	3	3/126 (2.38%)	3
Tooth infection ^* 1	3/129 (2.33%)	3	2/126 (1.59%)	2
Influenza ^* 1	3/129 (2.33%)	3	0/126 (0.00%)	0
Influenza like illness ^* 1	1/129 (0.78%)	1	3/126 (2.38%)	3
Injury, poisoning and procedural complications
Fall ^* 1	29/129 (22.48%)	63	20/126 (15.87%)	35
Laceration ^* 1	6/129 (4.65%)	7	7/126 (5.56%)	8
Contusion ^* 1	6/129 (4.65%)	8	3/126 (2.38%)	3
Excoriation ^* 1	5/129 (3.88%)	6	5/126 (3.97%)	5
Fracture ^* 1	4/129 (3.10%)	4	1/126 (0.79%)	1
Humerus fracture ^* 1	3/129 (2.33%)	3	2/126 (1.59%)	2
Rib fracture ^* 1	1/129 (0.78%)	1	3/126 (2.38%)	3
Investigations
Urine analysis abnormal ^* 1	4/129 (3.10%)	4	4/126 (3.17%)	4
Hepatic enzyme increased ^* 1	4/129 (3.10%)	5	3/126 (2.38%)	4
Lymphocyte count decreased ^* 1	4/129 (3.10%)	4	2/126 (1.59%)	2
White blood cell count decreased ^* 1	4/129 (3.10%)	5	0/126 (0.00%)	0
Gamma-glutamyl transferase increased ^* 1	4/129 (3.10%)	4	1/126 (0.79%)	1
Weight decreased ^* 1	3/129 (2.33%)	3	1/126 (0.79%)	1
Blood alkaline phosphatase increased ^* 1	3/129 (2.33%)	3	0/126 (0.00%)	0
Alanine aminotransferase increased ^* 1	2/129 (1.55%)	3	4/126 (3.17%)	4
Metabolism and nutrition disorders
Decreased appetite ^* 1	8/129 (6.20%)	9	4/126 (3.17%)	4
Hypokalaemia ^* 1	4/129 (3.10%)	4	1/126 (0.79%)	1
Abnormal loss of weight ^* 1	3/129 (2.33%)	3	2/126 (1.59%)	2
Musculoskeletal and connective tissue disorders
Muscular weakness ^* 1	11/129 (8.53%)	13	12/126 (9.52%)	15
Back pain ^* 1	10/129 (7.75%)	11	15/126 (11.90%)	16
Arthralgia ^* 1	10/129 (7.75%)	11	10/126 (7.94%)	12
Pain in extremity ^* 1	5/129 (3.88%)	6	13/126 (10.32%)	15
Musculoskeletal pain ^* 1	4/129 (3.10%)	4	3/126 (2.38%)	3
Musculoskeletal chest pain ^* 1	3/129 (2.33%)	3	2/126 (1.59%)	3
Myalgia ^* 1	2/129 (1.55%)	2	3/126 (2.38%)	4
Neck pain ^* 1	0/129 (0.00%)	0	4/126 (3.17%)	4
Nervous system disorders
Headache ^* 1	23/129 (17.83%)	29	15/126 (11.90%)	19
Muscle spasticity ^* 1	9/129 (6.98%)	9	12/126 (9.52%)	13
Paraesthesia ^* 1	9/129 (6.98%)	11	8/126 (6.35%)	8
Dizziness ^* 1	4/129 (3.10%)	4	0/126 (0.00%)	0
Tremor ^* 1	4/129 (3.10%)	4	0/126 (0.00%)	0
Hypoaesthesia ^* 1	1/129 (0.78%)	1	3/126 (2.38%)	4
Psychiatric disorders
Insomnia ^* 1	14/129 (10.85%)	16	11/126 (8.73%)	11
Depression ^* 1	12/129 (9.30%)	15	4/126 (3.17%)	4
Anxiety ^* 1	3/129 (2.33%)	3	3/126 (2.38%)	3
Renal and urinary disorders
Nephrolithiasis ^* 1	4/129 (3.10%)	5	7/126 (5.56%)	7
Respiratory, thoracic and mediastinal disorders
Cough ^* 1	3/129 (2.33%)	3	4/126 (3.17%)	5
Nasal congestion ^* 1	3/129 (2.33%)	3	3/126 (2.38%)	3
Dyspnoea ^* 1	1/129 (0.78%)	1	3/126 (2.38%)	3
Skin and subcutaneous tissue disorders
Cellulitis ^* 1	2/129 (1.55%)	2	3/126 (2.38%)	4
Skin infection ^* 1	1/129 (0.78%)	1	9/126 (7.14%)	10
Herpes zoster ^* 1	1/129 (0.78%)	1	3/126 (2.38%)	3
Folliculitis ^* 1	0/129 (0.00%)	0	3/126 (2.38%)	3
Rash ^* 1	8/129 (6.20%)	10	8/126 (6.35%)	8
Rash maculo-papular ^* 1	6/129 (4.65%)	6	2/126 (1.59%)	2
Dermatitis acneiform ^* 1	3/129 (2.33%)	3	2/126 (1.59%)	3
Pruritus ^* 1	3/129 (2.33%)	3	1/126 (0.79%)	1
Skin ulcer ^* 1	2/129 (1.55%)	2	3/126 (2.38%)	4
Vascular disorders
Hot flush ^* 1	5/129 (3.88%)	5	2/126 (1.59%)	2
Hypertension ^* 1	4/129 (3.10%)	4	7/126 (5.56%)	7
1 Term from vocabulary, MedDRA (Unspecified) * Indicates events were collected by non-systematic assessment

Limitations and Caveats

[Not Specified]

More Information

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.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Director, Medical Writing
Organization:	Medicinova Inc
Phone:	8582468680
EMail:	makhay@medicinova.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Bermel RA, Fedler JK, Kaiser P, Novalis C, Schneebaum J, Klingner EA, Williams D, Yankey JW, Ecklund DJ, Chase M, Naismith RT, Klawiter EC, Goodman AD, Coffey CS, Fox RJ. Optical coherence tomography outcomes from SPRINT-MS, a multicenter, randomized, double-blind trial of ibudilast in progressive multiple sclerosis. Mult Scler. 2021 Aug;27(9):1384-1390. doi: 10.1177/1352458520964409. Epub 2020 Oct 15.

Fox RJ, Coffey CS, Conwit R, Cudkowicz ME, Gleason T, Goodman A, Klawiter EC, Matsuda K, McGovern M, Naismith RT, Ashokkumar A, Barnes J, Ecklund D, Klingner E, Koepp M, Long JD, Natarajan S, Thornell B, Yankey J, Bermel RA, Debbins JP, Huang X, Jagodnik P, Lowe MJ, Nakamura K, Narayanan S, Sakaie KE, Thoomukuntla B, Zhou X, Krieger S, Alvarez E, Apperson M, Bashir K, Cohen BA, Coyle PK, Delgado S, Dewitt LD, Flores A, Giesser BS, Goldman MD, Jubelt B, Lava N, Lynch SG, Moses H, Ontaneda D, Perumal JS, Racke M, Repovic P, Riley CS, Severson C, Shinnar S, Suski V, Weinstock-Guttman B, Yadav V, Zabeti A; NN102/SPRINT-MS Trial Investigators. Phase 2 Trial of Ibudilast in Progressive Multiple Sclerosis. N Engl J Med. 2018 Aug 30;379(9):846-855. doi: 10.1056/NEJMoa1803583.

Layout table for additonal information

Responsible Party:	MediciNova
ClinicalTrials.gov Identifier:	NCT01982942
Other Study ID Numbers:	NN102 SPRINT - MS 1U01NS082329-01A1 ( U.S. NIH Grant/Contract ) RG 4778-A-6 ( Other Grant/Funding Number: National Multiple Sclerosis Society )
First Submitted:	October 29, 2013
First Posted:	November 13, 2013
Results First Submitted:	June 23, 2020
Results First Posted:	July 28, 2020
Last Update Posted:	July 28, 2020

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