Optical coherence tomography outcomes from SPRINT-MS, a multicenter, randomized, double-blind trial of ibudilast in progressive multiple sclerosis.

التفاصيل البيبلوغرافية
العنوان:	Optical coherence tomography outcomes from SPRINT-MS, a multicenter, randomized, double-blind trial of ibudilast in progressive multiple sclerosis.
المؤلفون:	Bermel RA; Mellen Center for Multiple Sclerosis Treatment and Research, Cleveland Clinic, Cleveland, OH, USA., Fedler JK; Data Coordinating Center, Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT), University of Iowa, Iowa City, IA, USA., Kaiser P; Cole Eye Institute, Cleveland Clinic, Cleveland, OH, USA., Novalis C; Digital Angiography Reading Center, Great Neck, NY, USA., Schneebaum J; Digital Angiography Reading Center, Great Neck, NY, USA., Klingner EA; Data Coordinating Center, Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT), University of Iowa, Iowa City, IA, USA., Williams D; Digital Angiography Reading Center, Great Neck, NY, USA., Yankey JW; Data Coordinating Center, Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT), University of Iowa, Iowa City, IA, USA., Ecklund DJ; Data Coordinating Center, Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT), University of Iowa, Iowa City, IA, USA., Chase M; Clinical Coordinating Center, Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT), Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA., Naismith RT; Department of Neurology, Washington University, St. Louis, MI, USA., Klawiter EC; Department of Neurology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA., Goodman AD; Department of Neurology, University of Rochester Medical Center, Rochester, NY, USA., Coffey CS; Data Coordinating Center, Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT), University of Iowa, Iowa City, IA, USA., Fox RJ; Mellen Center for Multiple Sclerosis Treatment and Research, Cleveland Clinic, Cleveland, OH, USA.
المصدر:	Multiple sclerosis (Houndmills, Basingstoke, England) [Mult Scler] 2021 Aug; Vol. 27 (9), pp. 1384-1390. Date of Electronic Publication: 2020 Oct 15.
نوع المنشور:	Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't
اللغة:	English
بيانات الدورية:	Publisher: SAGE Publications Country of Publication: England NLM ID: 9509185 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1477-0970 (Electronic) Linking ISSN: 13524585 NLM ISO Abbreviation: Mult Scler Subsets: MEDLINE
أسماء مطبوعة:	Publication: 2006- : London : SAGE Publications Original Publication: Houndmills, Basingstoke, Hampshire, UK : Stockton Press, c1995-
مواضيع طبية MeSH:	Multiple Sclerosis, Chronic Progressive/drug therapy, Pyridines/therapeutic use, Humans ; Tomography, Optical Coherence
مستخلص:	Background: The SPRINT-MS trial demonstrated benefit of ibudilast on brain atrophy over 96 weeks in progressive multiple sclerosis (MS). Optical coherence tomography (OCT) was performed in all trial participants. Objective: Report the OCT results of the SPRINT-MS trial. Methods: OCT was obtained at baseline and every 6 months using spectral domain OCT and analyzed by an OCT reading center. Change in each OCT outcome measure by treatment group was estimated using linear mixed models. Results: Change in pRNFL thickness was +0.0424 uM/year (95% confidence interval (CI): -0.3091 to 0.3939) for ibudilast versus -0.2630 uM (95% CI: -0.5973 to 0.0714) for placebo ( n = 244, p = 0.22). Macular volume change was -0.00503 mm ³ /year (-0.02693 to 0.01688) with ibudilast versus -0.03659 mm ³ /year (-0.05824 to -0.01494) for placebo in the Spectralis cohort ( n = 61, p = 0.044). For the Cirrus cohort, macular volume change was -0.00040 mm ³ /year (-0.02167, 0.020866) with ibudilast compared to -0.02083 mm ³ /year (-0.04134 to -0.00033) for placebo ( n = 183, p = 0.1734). Ganglion cell-inner plexiform layer thickness change, available from Cirrus, was -0.4893 uM/year (-0.9132, -0.0654) with ibudilast versus -0.9587 uM/year (-1.3677, -0.5498) with placebo ( n = 183, p = 0.12). Conclusion: Retinal thinning in MS may be attenuated by ibudilast. Sample size estimates suggest OCT can be a viable outcome measure in progressive MS trials if a therapy has a large treatment effect. Trial Registration: NN102/SPRINT-MS ClinicalTrials.gov number, NCT01982942.
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معلومات مُعتمدة:	U24 NS107205 United States NS NINDS NIH HHS; U01 NS077179 United States NS NINDS NIH HHS; U01 NS082329 United States NS NINDS NIH HHS; U24 NS107156 United States NS NINDS NIH HHS; U01 NS077352 United States NS NINDS NIH HHS
فهرسة مساهمة:	Keywords: Optical coherence tomography; ibudilast; multiple sclerosis; neuroprotection
سلسلة جزيئية:	ClinicalTrials.gov NCT01982942
المشرفين على المادة:	0 (Pyridines) M0TTH61XC5 (ibudilast)
تواريخ الأحداث:	Date Created: 20201015 Date Completed: 20211021 Latest Revision: 20220531
رمز التحديث:	20221213
مُعرف محوري في PubMed:	PMC8046841
DOI:	10.1177/1352458520964409
PMID:	33054533
قاعدة البيانات:	MEDLINE

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تدمد:	1477-0970
DOI:	10.1177/1352458520964409