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
Last Update Posted : May 9, 2018
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: 36 months ]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).
- Safety Measures: TEAEs (treatment-emergent adverse events), TESAEs (treatment-emergent serious adverse events), treatment discontinuations due to TEAEs, laboratory measures (chemistry, hematology, urinalysis), vital signs, electrocardiograms (ECGs). [ Time Frame: 36 months ]To evaluate the safety and tolerability of ibudilast (100 mg/day) versus placebo administered orally in subjects with primary progressive multiple sclerosis (PPMS) and secondary progressive multiple sclerosis (SPMS)
- Diffusion tensor imaging (DTI) in descending pyramidal white matter tracts [ Time Frame: 36 months ]
- Magnetization transfer ratio (MTR) imaging in normal-appearing brain tissue [ Time Frame: 36 months ]
- Retinal nerve fiber layer as measured by Optical coherence tomography (OCT) [ Time Frame: 36 months ]
- Cortical atrophy as measured by cortical longitudinal atrophy detection algorithm [CLADA] [ Time Frame: 36 months ]
- Inflammatory disease activity, as measured by T1 lesion volume, T2 lesion volume, and annualized relapse rate [ Time Frame: 36 months ]
- Disability, as measured by Expanded Disability Status Scale (EDSS) and Multiple Sclerosis Functional Composite (MSFC) [ Time Frame: 36 months ]
- Quality of Life, as measured by Multiple Sclerosis Impact Scale (MSIS-29), EuroQol 5 Dimensions (EQ-5D), and Short Form-36 Health Survey (SF-36) [ Time Frame: 36 months ]
- Cognitive impairment, as measured by Symbol Digit Modalities Test (SDMT) and the Selective Reminding Test (SRT). [ Time Frame: 36 months ]
- Neuropathic pain, as measured by Brief Pain Inventory (BPI) [ Time Frame: 36 months ]
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|