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Design, rationale, and baseline characteristics of the randomized double-blind phase II clinical trial of ibudilast in progressive multiple sclerosis.
Fox, Robert J; Coffey, Christopher S; Cudkowicz, Merit E; Gleason, Trevis; Goodman, Andrew; Klawiter, Eric C; Matsuda, Kazuko; McGovern, Michelle; Conwit, Robin; Naismith, Robert; Ashokkumar, Akshata; Bermel, Robert; Ecklund, Dixie; Koepp, Maxine; Long, Jeffrey; Natarajan, Sneha; Ramachandran, Srividya; Skaramagas, Thomai; Thornell, Brenda; Yankey, Jon; Agius, Mark; Bashir, Khurram; Cohen, Bruce; Coyle, Patricia; Delgado, Silvia; Dewitt, Dana; Flores, Angela; Giesser, Barbara; Goldman, Myla; Jubelt, Burk; Lava, Neil; Lynch, Sharon; Miravalle, Augusto; Moses, Harold; Ontaneda, Daniel; Perumal, Jai; Racke, Michael; Repovic, Pavle; Riley, Claire; Severson, Christopher; Shinnar, Shlomo; Suski, Valerie; Weinstock-Gutman, Bianca; Yadav, Vijayshree; Zabeti, Aram.
Afiliación
  • Fox RJ; Cleveland Clinic, Neurological Institute, Cleveland, OH, United States. Electronic address: foxr@ccf.org.
  • Coffey CS; Data Coordinating Center, NeuroNEXT, University of Iowa, Iowa City, IA, United States.
  • Cudkowicz ME; Clinical Coordinating Center, NeuroNEXT, Harvard Partners, Boston, MA, United States.
  • Gleason T; Patient Advocate, Seattle, WA, United States.
  • Goodman A; University of Rochester Medical Center, Rochester, NY, United States.
  • Klawiter EC; Massachusetts General Hospital, Boston, MA, United States.
  • Matsuda K; Medicinova Inc., La Jolla, CA, United States.
  • McGovern M; Clinical Coordinating Center, NeuroNEXT, Harvard Partners, Boston, MA, United States.
  • Conwit R; National Institutes of Neurological Disease and Stroke, Bethesda, MD, United States.
  • Naismith R; Washington University School of Medicine, St. Louis, MO, United States.
  • Ashokkumar A; Data Coordinating Center, NeuroNEXT, University of Iowa, Iowa City, IA, United States.
  • Bermel R; Cleveland Clinic, Neurological Institute, Cleveland, OH, United States.
  • Ecklund D; Data Coordinating Center, NeuroNEXT, University of Iowa, Iowa City, IA, United States.
  • Koepp M; Data Coordinating Center, NeuroNEXT, University of Iowa, Iowa City, IA, United States.
  • Long J; Data Coordinating Center, NeuroNEXT, University of Iowa, Iowa City, IA, United States.
  • Natarajan S; Cleveland Clinic, Neurological Institute, Cleveland, OH, United States.
  • Ramachandran S; Cleveland Clinic, Neurological Institute, Cleveland, OH, United States.
  • Skaramagas T; Cleveland Clinic, Neurological Institute, Cleveland, OH, United States.
  • Thornell B; Clinical Coordinating Center, NeuroNEXT, Harvard Partners, Boston, MA, United States.
  • Yankey J; Data Coordinating Center, NeuroNEXT, University of Iowa, Iowa City, IA, United States.
  • Agius M; University of California at Davis, Sacramento, CA; currently at Barrows Neurological Institute, Phoenix, AZ, United States.
  • Bashir K; University of Alabama at Birmingham, Birmingham, AL, United States.
  • Cohen B; Northwestern University, Chicago, IL, United States.
  • Coyle P; State University of New York, Stony Brook, NY, United States.
  • Delgado S; University of Miami School of Medicine, Miami, FL, United States.
  • Dewitt D; University of Utah, Salt Lake City, UT, United States.
  • Flores A; University of Texas Southwestern Medical Center, Dallas, TX, United States.
  • Giesser B; University of California at Los Angeles, Los Angeles, CA, United States.
  • Goldman M; University of Virginia at Charlottesville, Charlottesville, VA, United States.
  • Jubelt B; State University of New York Upstate Medical University, Syracuse, NY, United States.
  • Lava N; Emory University, Atlanta, GA, United States.
  • Lynch S; University of Kansas Medical Center, Kansas City, KS, United States.
  • Miravalle A; University of Colorado at Denver, Aurora, CO, United States.
  • Moses H; Vanderbilt University, Nashville, TN, United States.
  • Ontaneda D; Cleveland Clinic, Neurological Institute, Cleveland, OH, United States.
  • Perumal J; Weill Cornell Medical College, New York, NY, United States.
  • Racke M; The Ohio State University, Columbus, OH, United States.
  • Repovic P; Swedish Medical Center at Seattle, Seattle, WA, United States.
  • Riley C; Columbia University Medical Center, New York, NY, United States.
  • Severson C; Brigham and Women's Hospital, Brookline, MA, United States.
  • Shinnar S; Montefiore Medical Center, Bronx, NY, United States.
  • Suski V; University of Pittsburgh Medical Center, Pittsburgh, PA, United States.
  • Weinstock-Gutman B; State University of New York Buffalo, Buffalo, NY, United States.
  • Yadav V; Oregon Health and Science University, Portland, OR, United States.
  • Zabeti A; University of Cincinnati, Cincinnati, OH, United States.
Contemp Clin Trials ; 50: 166-77, 2016 09.
Article en En | MEDLINE | ID: mdl-27521810
BACKGROUND: Primary and secondary progressive multiple sclerosis (MS), collectively called progressive multiple sclerosis (PMS), is characterized by gradual progression of disability. The current anti-inflammatory treatments for MS have little or no efficacy in PMS in the absence of obvious active inflammation. Optimal biomarkers for phase II PMS trials is unknown. Ibudilast is an inhibitor of macrophage migration inhibitor factor and phosphodiesterases-4 and -10 and exhibits possible neuroprotective properties. The goals of SPRINT-MS study are to evaluate the safety and efficacy of ibudilast in PMS and to directly compare several imaging metrics for utility in PMS trials. METHODS: SPRINT-MS is a randomized, placebo-controlled, phase II trial of ibudilast in patients with PMS. Eligible subjects were randomized 1:1 to receive either ibudilast (100mg/day) or placebo for 96weeks. Imaging is conducted every 24weeks for whole brain atrophy, magnetization transfer ratio, diffusion tensor imaging, cortical brain atrophy, and retinal nerve fiber layer thickness. Clinical outcomes include neurologic disability and patient reported quality of life. Safety assessments include laboratory testing, electrocardiography, and suicidality screening. RESULTS: A total of 331 subjects were enrolled, of which 255 were randomized onto active study treatment. Randomized subjects were 53.7% female and mean age 55.7 (SD 7.3) years. The last subject is projected to complete the study in May 2017. CONCLUSION: SPRINT-MS is designed to evaluate the safety and efficacy of ibudilast as a treatment for PMS while simultaneously validating five different imaging biomarkers as outcome metrics for use in future phase II proof-of-concept PMS trials.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Inhibidores de Fosfodiesterasa / Piridinas / Esclerosis Múltiple Crónica Progresiva Tipo de estudio: Clinical_trials Aspecto: Patient_preference Límite: Adult / Humans / Middle aged Idioma: En Revista: Contemp Clin Trials Asunto de la revista: MEDICINA / TERAPEUTICA Año: 2016 Tipo del documento: Article Pais de publicación: Estados Unidos
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Inhibidores de Fosfodiesterasa / Piridinas / Esclerosis Múltiple Crónica Progresiva Tipo de estudio: Clinical_trials Aspecto: Patient_preference Límite: Adult / Humans / Middle aged Idioma: En Revista: Contemp Clin Trials Asunto de la revista: MEDICINA / TERAPEUTICA Año: 2016 Tipo del documento: Article Pais de publicación: Estados Unidos