Safety, Tolerability and Activity Study of Ibudilast in Subjects With Progressive Multiple Sclerosis
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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
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Study Type | Interventional |
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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 |
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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 | |
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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 | |
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[Not Specified]
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Age, Customized
Mean (Standard Deviation) Unit of measure: Years |
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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 |
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Number Analyzed | 129 participants | 126 participants | 255 participants | |
Female |
67 51.9%
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69 54.8%
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136 53.3%
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Male |
62 48.1%
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57 45.2%
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119 46.7%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 129 participants | 126 participants | 255 participants | |
Hispanic or Latino |
4 3.1%
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3 2.4%
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7 2.7%
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Not Hispanic or Latino |
125 96.9%
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121 96.0%
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246 96.5%
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Unknown or Not Reported |
0 0.0%
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2 1.6%
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2 0.8%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 129 participants | 126 participants | 255 participants | |
American Indian or Alaska Native |
1 0.8%
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0 0.0%
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1 0.4%
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Asian |
0 0.0%
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0 0.0%
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0 0.0%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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Black or African American |
4 3.1%
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7 5.6%
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11 4.3%
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White |
122 94.6%
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114 90.5%
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236 92.5%
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More than one race |
2 1.6%
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1 0.8%
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3 1.2%
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Unknown or Not Reported |
0 0.0%
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4 3.2%
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4 1.6%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 129 participants | 126 participants | 255 participants |
129 | 126 | 255 |
Name/Title: | Director, Medical Writing |
Organization: | Medicinova Inc |
Phone: | 8582468680 |
EMail: | makhay@medicinova.com |
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 |