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SPRINT-MS/NN 102 phase II trial of ibudilast in progressive MS: top-line results
ECTRIMS Online Library. Fox R. Oct 28, 2017; 202642
Robert J. Fox
Robert J. Fox
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Abstract: 278

Type: Oral

Background: Treatment options for progressive MS are limited. Ibudilast, a phosphodiesterase- and macrophage inhibitory factor-inhibitor, was suggested to have a neuroprotective effect in relapsing-remitting MS. We conducted a phase II clinical trial of ibudilast in primary and secondary progressive MS.
Objective: Report top-line safety, tolerability, and efficacy of ibudilast in progressive MS.
Methods: 255 subjects with primary or secondary progressive MS, with evidence for disability progression in prior two years, were randomized to receive either ibudilast up to 100 mg/d or matching placebo, and followed over 96 weeks. Clinical and imaging outcomes were assessed every 24 weeks. Primary outcome was change in brain atrophy as measured by brain parenchymal fraction (BPF) over 96 weeks. Secondary outcomes included magnetization transfer ratio, diffusion tensor imaging, and optical coherence tomography. Analysis was based on a modified ITT (mITT) approach: subjects who received ≥1 dose of study medication and had ≥1 BPF efficacy assessment after baseline. Linear mixed effects modeling was used to estimate the rate of change within imaging measures for each treatment group. The difference in the estimated rates between groups was used to assess efficacy.
Results: Last follow-up visit was completed on 11May2017. Out of 255 randomized subjects, 244 were included in the mITT population for efficacy analyses. Of these 244 subjects, 220 (90.2%) completed 96-week follow-up, with 184 subjects (83.6%) remaining on assigned study medication for the full 96-week treatment period. Primary outcome, several secondary outcomes, and safety data will be presented.
Conclusions: The NN102/SPRINT-MS study will evaluate the activity, safety, and tolerability of ibudilast in progressive MS.
Support by National Institutes of Health (U01NS082329), National Multiple Sclerosis Society (RG-5184-A-6), National Institute of Neurological Disorders and Stroke for the NeuroNEXT Clinical Coordinating Center (U01NS077179) and Data Coordinating Center (U01NS077352) and Medicinova.
Disclosure: Dr. Fox has received consulting fees from Biogen Idec, GlaxoSmithKline, Novartis, Questcor, Teva, and Xenoport; research support from Novartis. Dr. Coffey has received consulting fees from ZZ Biotech, LLC.
Dr. Cudkowicz has received consulting fees from Astra Zenica, Cytokinetics, Biohaven, Denali, Biogen-Idec, and Genentech. Dr. Goodman has received received consulting fees from Acorda Therapeutics, Actelion, Biogen-Idec, Genzyme-sanofi, GW Pharma, Mylan, Novartis, Teva, and Vaccinex for consulting services; research support from Acorda Therapeutics, Avanir, Biogen Idec, EMD Serono, Genzyme-sanofi, Novartis, Ono, Roche, Sun, Takeda, and Teva Neuroscience. Dr. Klawiter has received research grants from Atlas5D, Biogen, EMD Serono, and Roche. Dr. Klawiter has received consulting fees from Acorda, Atlas5D, Biogen, Celgene, EMD Serono, Genentech, and Shire. Dr. Matsuda is the Chief medical officer of Medicinova. Dr. Naismith has received consulting fees from Acorda, Alkermes, Bayer, Biogen, EMD Serono, Genentech, Genzyme, Novartis and Teva Neuroscience. Dr. Bermel has received consulting fees from Biogen, Novartis, Genentech, and Genzyme; research support from Biogen and Novartis. Dr. Lowe has received consulting fees from Siemens Medical Systems, Inc. Dr. Alvarez has received consulting fees from Biogen, Celgene, Genzume, Genentech, Novartis and TG pharmaceuticals and has received research funding from Acorda, Biogen, Genentech, Novartis and Rocky Mountain MS Center. Dr. Cohen has received consulting fees from EMD Serono, Mylan, and Novartis; research support through NU from Hoffman La Roche/Genentech, Novartis, and MedDay. Dr. Coyle has received consulting fees from Accordant, Acorda, Bayer, Biogen, Celgene, Genentech/Roche, Novartis, Sanofi Genzyme, Serono, Teva; and research support from Actelion, Alkermes, Genentech/Roche, MedDay, NINDS and Novartis. Dr. Dewitt has received consulting and speaking fees from Novartis and Teva. Dr. Flores has received consulting/speaker fees and research support from Biogen and Genentech. Dr. Goldman has received consulting fees or served on the scientific advisory board for Adamas, Acorda, Biogen, EMD Serono, ENDECE, Genzyme, and Novartis Pharmaceuticals; research support from Biogen, Medday, and Novartis. Dr. Lynch has received support from by Biogen, Teva, Novartis, Opexa, Genzyme, Roche, Genentech, Sun Pharma and Acorda. Dr. Moses has received consulting fees from Biogen-Idec, Teva Neuroscience, EMD-Serono, Medimmune, Novartis, Genzyme and Bayer; speaking fees from Biogen-Idec, Teva Neuroscience, EMD Serono, Bayer and Genzyme. Dr. Ontaneda has received consulting fees from Biogen Idec, Genentech, Genzyme, and Merck; research support from Race to Erase MS Foundation. Dr. Racke has received consulting/speaking fees or research support from Actelion, Alkermes, Coherus Bioscience, Genentech, Novartis, TG Therapeutics and NIH. Dr. Repovic has received consulting/speaker fees from Biogen, Genzyme, Teva, EMD Serono, Acorda and Novartis. Dr. Riley has served on the advisory board for Teva. Dr. Severson has received consulting fees from Biogen-Idec, Genentech and Novartis; speaking fees from Foundation of Neurologic Diseases and MS cure fund. Dr. Weinstock-Guttman has received consulting and speaking fees from Biogen Idec, Teva Neuroscience, EMD Serono, Novartis, Genzyme, Sanofi and Genentech; research support from Biogen Idec, Teva Neuroscience, EMD Serono, Novartis, Genzyme, Sanofi, Genentech and Mallinckrodt Pharmaceuticals, Inc; serves as an editorial board memeber for BMJ Neurology, Journal of International MS and CNS Drugs. Dr. Zabeti has received speaking fees from Acorda, Biogen, and Genzyme/Sanofi; research support from Actelion, Genentech/Roche, Novartis, and Opera.
Drs. Apperson, Bashir, Conwit, Debbins, Delgado, Giesser, Jubelt, Lava, Nakamura, Narayanan, Natarajan, Perumal, Sakaie, Shinnar, Suski, Yadav, and Zhou, Mr. Gleason, and Yankey, Ms. Ashokkumar, Ecklund, Huang, Klinger, Koepp, McGovern, and Thornell report no disclosures.

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