Safety, Tolerability and Activity Study of Ibudilast in Subjects With Progressive Multiple Sclerosis
Summary
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).
Timeline
- Start
- 2013-11
- Primary completion
- 2017-05
- Completion
- 2017-12
Outcome
Met primary endpoint
registry analysis (superiority test); Ibudilast vs Placebo Oral Capsule; p = 0.04; t-test, 2 sided reads as met primary endpoint NCT01982942 ↗
release “As previously reported in October 2017, the SPRINT-MS Phase 2b Trial of MN-166 (ibudilast) in progressive MS achieved both primary endpoints.” reads as met primary endpoint medicinova.com ↗
release “today announced that the SPRINT-MS Phase 2b Trial of MN-166 (ibudilast) in progressive multiple sclerosis (progressive MS) achieved both primary endpoints.” reads as met primary endpoint medicinova.com ↗
release “SPRINT-MS Phase 2b Trial of MN-166 (ibudilast) in Progressive MS: Achieved a Statistically Significant 48% Reduction” reads as met primary endpoint medicinova.com ↗
release “Primary Endpoint #1: MN-166 (ibudilast) demonstrated a statistically significant 48% reduction in the rate of progression of whole brain atrophy” reads as met primary endpoint medicinova.com ↗
release “positive Optical Coherence Tomography (OCT) results from the SPRINT-MS Phase 2b trial of MN-166 (ibudilast) in progressive multiple sclerosis” reads as unknown medicinova.com ↗
release “OCT was a secondary outcome measure in the SPRINT-MS trial.” reads as unknown medicinova.com ↗
release “In the Phase 2b trial in PMS, MN-166 achieved both primary endpoints” reads as met primary endpoint medicinova.com ↗
Publications
- Krijnen EA, Bruijn AM, Eloyan A, Schoonheim MM, Fox RJ, Klawiter EC. Evaluation of cortical pathology in primary-progressive multiple sclerosis: a post hoc analysis of the SPRINT-MS trial. BMJ Neurol Open. 2026 Jan 5;8(1):e001335. doi: 10.1136/bmjno-2025-001335. eCollection 2026.
- Novak A, Harvey T, Wojdala A, Teunissen C, Fox R. Effect of Ibudilast vs Placebo on GFAP and Contactin levels in a phase 2 clinical trial in progressive multiple sclerosis. Neurol Open Access. 2025 Dec;1(4):10.1212/wn9.0000000000000040. doi: 10.1212/wn9.0000000000000040. Epub 2025 Nov 21.
- Singh V, Zheng Y, Ontaneda D, Mahajan KR, Holloman J, Fox RJ, Nakamura K, Trapp BD. Disability independent of cerebral white matter demyelination in progressive multiple sclerosis. Acta Neuropathol. 2024 Aug 31;148(1):34. doi: 10.1007/s00401-024-02796-w.
- Nakamura K, Zheng Y, Mahajan KR, Cohen JA, Fox RJ, Ontaneda D. Effect of ibudilast on thalamic magnetization transfer ratio and volume in progressive multiple sclerosis. Mult Scler. 2023 Sep;29(10):1257-1265. doi: 10.1177/13524585231187289. Epub 2023 Aug 3.
- Bermel RA, Fedler JK, Kaiser P, Novalis C, Schneebaum J, Klingner EA, Williams D, Yankey JW, Ecklund DJ, Chase M, Naismith RT, Klawiter EC, Goodman AD, Coffey CS, Fox RJ. Optical coherence tomography outcomes from SPRINT-MS, a multicenter, randomized, double-blind trial of ibudilast in progressive multiple sclerosis. Mult Scler. 2021 Aug;27(9):1384-1390. doi: 10.1177/1352458520964409. Epub 2020 Oct 15.
- Fox RJ, Coffey CS, Conwit R, Cudkowicz ME, Gleason T, Goodman A, Klawiter EC, Matsuda K, McGovern M, Naismith RT, Ashokkumar A, Barnes J, Ecklund D, Klingner E, Koepp M, Long JD, Natarajan S, Thornell B, Yankey J, Bermel RA, Debbins JP, Huang X, Jagodnik P, Lowe MJ, Nakamura K, Narayanan S, Sakaie KE, Thoomukuntla B, Zhou X, Krieger S, Alvarez E, Apperson M, Bashir K, Cohen BA, Coyle PK, Delgado S, Dewitt LD, Flores A, Giesser BS, Goldman MD, Jubelt B, Lava N, Lynch SG, Moses H, Ontaneda D, Perumal JS, Racke M, Repovic P, Riley CS, Severson C, Shinnar S, Suski V, Weinstock-Guttman B, Yadav V, Zabeti A; NN102/SPRINT-MS Trial Investigators. Phase 2 Trial of Ibudilast in Progressive Multiple Sclerosis. N Engl J Med. 2018 Aug 30;379(9):846-855. doi: 10.1056/NEJMoa1803583.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ibudilast | Small molecule | 50 mg | Oral |