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
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the safety, tolerability and activity of ibudilast administered twice daily over a 96 week period in subjects with primary or secondary progressive multiple sclerosis who are currently untreated with long-term MS disease modifying therapy (DMT) or who are receiving either glatiramer acetate (GA) or interferon beta-1, any formulation (IFNβ-1A [Avonex, Rebif] or IFNβ-1B [Betaseron, Extavia]). Study drug or placebo will be administered to a total of 250 male and female subjects from 21 to 65 years old, inclusive, in two treatment groups. Randomization of subjects will be stratified by disease status (primary progressive multiple sclerosis or secondary progressive multiple sclerosis) and immunomodulating therapy status: current use of immunomodulating therapy or no current use of immunomodulating therapy.
The study will consist of a screening phase (up to 30 days) followed by a treatment phase (96 weeks) and a follow-up visit (1 month post Week 96 visit). Following the screening phase, subjects who continue to meet entry criteria will be randomly assigned to 1 of 2 treatment groups: doses up to ibudilast 100 mg/day or matching-placebo in a 1:1 ratio. Study drug will be administered twice daily (BID), e.g., ibudilast 50 mg or placebo taken in the morning and evening).
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis, Primary Progressive Multiple Sclerosis, Secondary Progressive||Drug: ibudilast Drug: Placebo oral capsule||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||255 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Phase 2 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Activity of Ibudilast (MN-166) in Subjects With Progressive Multiple Sclerosis|
|Study Start Date :||November 2013|
|Actual Primary Completion Date :||May 2017|
|Actual Study Completion Date :||December 2017|
Subjects will receive up to 100 mg/d ibudilast for 96 weeks.
Subjects randomly assigned to the ibudilast (MN-166) cohort will receive up to 100 mg/day for 96 weeks.
Other Name: MN-166
Placebo Comparator: Placebo Oral Capsule
Subjects will receive placebo for 96 weeks.
Drug: Placebo oral capsule
Subjects randomly assigned to the placebo cohort will receive placebo oral capsule for 96 weeks.
- Covariate-adjusted Mean Rate of Change in Brain Atrophy Over 96 Weeks as Measured by Brain Parenchymal Fraction (BPF). [ Time Frame: 96 weeks ]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.
- Percentage of Participants With Adverse Events. [ Time Frame: 96 weeks ]Safety Measures: percentage of participants who experienced treatment-emergent adverse events, clinically significant abnormal laboratory and electrocardiogram results.
- Diffusion Tensor Imaging (DTI) in Descending Pyramidal White Matter Tracts [ Time Frame: 48 weeks ]Diffusion tensor imaging estimates the three-dimensional diffusion of water in brain tissue and has been explored as an outcome in MS.
- Magnetization Transfer Ratio (MTR) Imaging in Normal-appearing Brain Tissue [ Time Frame: 96 weeks ]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.
- Retinal Nerve Fiber Layer as Measured by Optical Coherence Tomography (OCT). [ Time Frame: 96 weeks ]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.
- New T1 Lesions Since Baseline [ Time Frame: 96 weeks ]New T1 lesions since baseline as measured by least square mean (90% confidence interval).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01982942
|Principal Investigator:||Robert J Fox, MD, FAAN||The Cleveland Clinic|