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Trial record 11 of 19 for:    ibudilast

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

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: 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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ibudilast Placebo Oral Capsule
Hide 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
Arm/Group Title Ibudilast Placebo Oral Capsule Total
Hide 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
Hide 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
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
129 126 255
1.Primary Outcome
Title Covariate-adjusted Mean Rate of Change in Brain Atrophy Over 96 Weeks as Measured by Brain Parenchymal Fraction (BPF).
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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.
Hide Description Safety Measures: percentage of participants who experienced treatment-emergent adverse events, clinically significant abnormal laboratory and electrocardiogram results.
Time Frame 96 weeks
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
modified intent-to-treat population
Arm/Group Title Ibudilast Placebo Oral Capsule
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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).
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide Description New T1 lesions since baseline as measured by least square mean (90% confidence interval).
Time Frame 96 weeks
Hide Outcome Measure Data
Hide 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
Hide 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)
Time Frame 100 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ibudilast Placebo Oral Capsule
Hide 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%)    
Hide 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
Hide 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
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
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