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

ClinicalTrials.gov ID: NCT01982942

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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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID: NCT01982942
Recruitment status: Completed
Study type: Interventional
Phase: Phase 2
Lead sponsor: MediciNova; Industry
Enrollment: 255 participants

Conditions and interventions

Conditions

Interventions

ibudilast Drug
Placebo oral capsule Drug

Drug

Eligibility (public fields only)

Age range: 21 Years to 65 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Nov 2013 (Type not available)
Primary completion: May 2017 (Actual)
Completion: Dec 2017 (Actual)
Last update posted: Jul 28, 2020

2013 – 2017

United States locations

U.S. sites: 28
U.S. states: 18
U.S. cities: 26

Facility	City	State	ZIP	Site status
University of Alabama at Birmingham	Birmingham	Alabama	35294	—
University of California Davis	Davis	California	95817	—
University of California Los Angeles	Los Angeles	California	90095	—
University of Colorado Denver	Denver	Colorado	80045	—
University of Miami Miller School of Medicine	Miami	Florida	33136	—
Emory University	Atlanta	Georgia	30322	—
Northwestern University	Evanston	Illinois	60208	—
University of Kansas Medical Center	Kansas City	Kansas	66160	—
Massachusetts General Hospital	Boston	Massachusetts	02114	—
Brigham and Women's Hospital	Boston	Massachusetts	02445	—
Washington University School of Medicine in St Louis	St Louis	Missouri	63110	—
University at Buffalo, The State University of New York	Buffalo	New York	14260	—
Cornell Medical College	New York	New York	10021	—
Columbia University Medical Center	New York	New York	10032	—
University of Rochester	Rochester	New York	14627	—
University at Stony Brook, The State University of New York	Stony Brook	New York	11794	—
University at Upstate, The State University of New York	Syracuse	New York	13210	—
Montefiore Medical Center	The Bronx	New York	10467	—
University of Cincinnati, Department of Neurology	Cincinnati	Ohio	45267	—
Cleveland Clinic	Cleveland	Ohio	44195	—
Ohio State University	Columbus	Ohio	43210	—
Oregon Health and Science University	Portland	Oregon	97239	—
University of Pittsburgh	Pittsburgh	Pennsylvania	15261	—
Vanderbilt University	Nashville	Tennessee	37235	—
University of Texas Southwestern Medical Center	Dallas	Texas	75390	—
University of Utah	Salt Lake City	Utah	84112	—
University of Virginia Charlottesville	Charlottesville	Virginia	22904	—
Swedish Medical Center - Seattle	Seattle	Washington	98122	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT01982942, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jul 28, 2020 · Synced Nov 13, 2026