NN102 SPRINT-MS

SPRINT-MS: "A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Activity of Ibudilast (MN-166) in Subjects with Progressive Multiple Sclerosis"

 

Robert J. Fox, MD, MS, FAAN is the Protocol Principal Investigator for the study “A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Activity of Ibudilast (MN-166)  in Subjects with Progressive Multiple Sclerosis”. 

Multiple Sclerosis (MS) is a chronic, inflammatory demyelinating disease of the central nervous system that affects 400,000 people in the US and 2 million people worldwide. Those affected with the disease are characterized by their progression into one of three variants: relapsing-remitting, secondary-progressive and primary-progressive. Despite recent improvements in pharmacotherapy for relapsing-remitting Multiple Sclerosis (RRMS), there are no therapies with demonstrated efficacy in progressive Multiple Sclerosis in the absence of relapses.

We are doing this research study to determine the safety, tolerability and activity of ibudilast (MN-166) administered twice daily over a 96 week period in subjects with primary and secondary-progressive multiple sclerosis. The study will be conducted by the NIH-funded NeuroNEXT Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT) in NeuroNEXT sites around the United States.  A total of 250 male and female subjects from 21 to 65 years old, inclusive, are planned to be enrolled into 2 treatment arms (ibudilast or matching-placebo). The trial will utilize advanced brain imaging to assess activity and correlate clinical activity with these imaging measures. 

This study is also being supported by Medicinova and the National Multiple Sclerosis Society as part of a private-public partnership with the NIH.

 

Participating clinical study sites are:

 

Northeast:

 

·         Albert Einstein College of Medicine Yeshiva University, Bronx, NY

o   Principal Investigator: Corey McGraw, MD

o   Coordinator: Donna Patch, RN

Email: donna.patch@einstein.yu.edu

 

·         Columbia University Medical Center, New York, NY

o   Principal Investigator: Claire S. Riley, MD

o   Coordinator: Deborah E. Gohs

Email: deg15@columbia.edu

 

·         Weill Cornell Medical College, New York, NY

o   Principal Investigator: Jai Perumal, MD

o   Coordinator: Bill Nikolov

Email: Bln2001@med.cornell.edu

 

·         Brigham and Women's Hospital, Boston, MA

o   Principal Investigator: Guy Buckle, MD

o   Coordinator: Sandra L. Cook, RN

Email: scook@partners.org

 

·         Massachusetts General Hospital, Boston, MA

o   Principal Investigator: Eric Klawiter, MD

o   Coordinator: Anne Bozik

Email: abozik@partners.org

 

·         SUNY Upstate, Syracuse, NY

o   Principal Investigator: Burk Jubelt, MD

o   Coordinator: Andrea McGlond

Email: mcglonda@upstate.edu

 

·         SUNY Buffalo, Buffalo, NY

o   Principal Investigator: Bianca Weinstock-Gutman, MD

o   Coordinator: Kara Patrick

Email: KPatrick@buffalo.edu

 

·         SUNY Stony Brook, Stony Brook, NY

o   Principal Investigator: Patricia Coyle, MD

o   Coordinator: Traci Brower

Email: Traci.Brower@stonybrookmedicine.edu

 

·         University of Pittsburgh, Pittsburgh, PA

o   Principal Investigator: Galen Mitchell, MD

o   Coordinator: Kerry Oddis

Email: kmoddis@upmc.edu

 

·         University of Rochester, Rochester, NY

o   Principal Investigator: Andrew Goodman, MD

o   Coordinator: Eileen Scheid

Email: Eileen_scheid@urmc.rochester.edu

 

Midwest:

 

·         Cleveland Clinic, Cleveland, OH

o   Principal Investigator: Daniel Ontaneda, MD

o   Coordinator: John Mays

Email: maysj1@ccf.org

 

·         Northwestern University, Chicago, IL

o   Principal Investigator: Joy Derwenskus, MD

o   Coordinator: Linda Reisberg

Email: l-reisberg@northwestern.edu

 

·         Ohio State University, Columbus, OH

o   Principal Investigator: Aaron Boster, MD

o   Coordinator: Misty Cost

Email: misty.cost@osumc.edu

 

·         University of Cincinnati, Cincinnati, OH

o   Principal Investigator: Aram Zabeti, MD

o   Coordinator: Kim Moeller

Email: moelleky@ucmail.uc.edu

 

·         University of Kansas Medical Center, Kansas City, KS

o   Principal Investigator: Sharon Lynch, MD

o   Coordinator: Lisa Schmidt, LPN

Email: lschmidt@kumc.edu

 

·         Washington University in St. Louis School of Medicine, St. Louis, MO

o   Principal Investigator: Robert Naismith, MD

o   Coordinator: Mengesha Teshome

Email: teshomem@neuro.wustl.edu

 

South:

 

·         Emory University, Atlanta, GA

o   Principal Investigator: Neil Lava, MD

o   Coordinator: Kanoa Folami

Email: kfolami@emory.edu

 

·         University of Alabama at Birmingham, Birmingham, AL

o   Principal Investigator: Khurram Bashir, MD

o   Coordinator: Beverly Layton

Email: blayton@uab.edu

 

·         University of Miami School of Medicine, Miami, FL

o   Principal Investigator: Kottil Rammohan, MD

o   Coordinator: Gloria Rodriguez

Email: GRodriguez13@med.miami.edu

 

·         University of Texas Southwestern Medical Center, Dallas, TX

o   Principal Investigator: Donna Graves, MD

o   Coordinator: Sam Hughes

Email: samuel.hughes@utsouthwestern.edu

 

·         University of Virginia – Charlottesville, Charlottesville, VA       

o   Principal Investigator: Myla Goldman, MD

o   Coordinator: Stephanie Lowenhaupt, RN, MBA, CCRC

Email: SAL3Q@hscmail.mcc.virginia.edu

 

·         Vanderbilt University, Nashville, TN

o   Principal Investigator: Harold Moses, MD

o   Coordinator: Jennifer Scott, RN

Email: Jennifer.l.scott@vanderbilt.edu

 

West:

 

·         Oregon Health and Science University, Portland, OR

o   Principal Investigator: Vijayshree Yadav, MD

o   Coordinator: Debbie Griffith

Email: griffide@ohsu.edu  

 

·         Swedish Medical Center – Seattle, Seattle, WA

o   Principal Investigator: Pavle Repovic, MD, PhD

o   Coordinator: Becky Wood

Email: Becky.Wood@swedish.org

 

·         University of California – Davis, Sacramento, CA

o   Principal Investigator: Mark Agius, MD

o   Coordinator: Randev Sandhu, CCRP

Email: rssandhu@ucdavis.edu

 

·         University of California - Los Angeles, Los Angeles, CA

o   Principal Investigator: Callene Momtazee, MD

o   Coordinator: Jenny Bardens

Email: JBardens@mednet.ucla.edu

 

·         University of Colorado – Denver, Denver, CO

o   Principal Investigator: Augusto Miravalle, MD

o   Coordinator: Kathryn Connelly

Email: kathryn.connelly@ucdenver.edu

 

·         University of Utah, Salt Lake City, UT

o   Principal Investigator: Dana DeWitt, MD

o   Coordinator: Tammy Floore, RN

Email: Tammy.floore@hsc.utah.edu