Publications

Publications by Date

  • Virtual coordinator and site training and reorganization of a multisite consortium upon grant renewal: Challenges of the NeuroNEXT network

    Authors: Lowenhaupt, Stephanie; Malloy, Angela
    Virtual coordinator and site training and reorganization of a multisite consortium upon grant renewal: Challenges of the NeuroNEXT network
    Contemporary Clinical Trials Communications.
    September 2021;
    Volume 23
  • NeuroNEXT Infrastructure Paper

    Merit Cudkowicz, MD, MSc; Marianne K. Chase, BA; Christopher S. Coffey, PhD; Dixie J. Ecklund, RN, MSN, MBA; Brenda J. Thornell, BA; Codrin Lungu, MD; Katy Mahoney, BS; Laurie Gutmann, MD; JeremyM. Shefner,MD, PhD; Kevin J. Staley, MD; Michael Bosch, RN; Eric Foster, PhD; Jeffrey D. Long, PhD; Emine O. Bayman, PhD; James Torner, PhD; Jon Yankey, MS; Richard Peters, BS; Trevis Huff, BSE; Robin A. Conwit, MD; and the NeuroNEXT Clinical Study Sites
    Seven-Year Experience From the National Institute of Neurological Disorders and Stroke-Supported Network for Excellence in Neuroscience Clinical Trials
    JAMA Neurology.
    June 2020;
    77
    (6)
    755-763.
    PubMed: PMC7483960
  • NN102 Manuscript

    Ken Sakaie, Janel K Fedler, Jon W Yankey, Kunio Nakamura, Josef Debbins, Mark J Lowe, Paolo Raska, Robert J Fox
    Influence of equipment changes on MRI measures of brain atrophy and brain microstructure in a placebo-controlled trial of ibudilast in progressive multiple sclerosis
    Multiple Sclerosis Journal - Experimental, Translational and Clinical.
    April-June 2021;
    1-10.
  • NN102 Manuscript

    Naismith RT, Bernel RA, Coffey CS, Goodman AD, Fedler JK, Chase M, Klawiter EC, Nakamura K, Narayanan S, Goebel C, Yankey JW, Klingner EA, Fox RJ.
    Effects of Ibudilast on MRI measures in the Phase 2 SPRINT-MS Study
    Neurology.
    2021 Jan 26;
    96
    (4)
    e491-e500.
    PubMed: 33268562
  • NN102 Manuscript

    Goodman AD, Fedler JK, Yankey J, Klingner EA, Ecklund DJ, Goebel CV, Bernel RA, Chase M, Coffey CS, Klawiter EC, Naismith RT, Fox RJ on behalf of the SPRINT-MS Investigators.
    Response to Ibudilast treatment according to progressive multiple sclerosis disease phenotype
    Annals of Clinical & Translational Neurology.
    2021 Jan;
    8
    (1)
    111-118.
    PubMed: PMC7818089
  • NN102 OCT Manuscript

    Robert A Bermel, Janel K Fedler, Peter Kaiser, Cindy Novalis, Jeff Schneebaum, Elizabeth A Klingner, Dawn Williams, Jon W Yankey, Dixie J Ecklund, Marianne Chase, Robert T Naismith, Eric C Klawiter, Andrew D Goodman, Christopher S Coffey and Robert J Fox
    Optical coherence tomography outcomes from SPRINT-MS, a multicenter, randomized, double-blind trial of ibudilast in progressive multiple sclerosis
    Multiple Sclerosis Journal.
    2020 Oct 15;
    PubMed: 33054533
  • NN105 Primary Manuscript

    Michael J. Brownstein, Neal G. Simon, Jeffrey D. Long, Jon Yankey, Hilda T. Maibach, Merit Cudkowicz, Christopher Coffey, Robin A. Conwit, Codrin Lungu, Karen E. Anderson, Steven M. Hersch, Dixie J. Ecklund, Eve M. Damiano, Debra E. Itzkowitz, Shifang Lu, Marianne K. Chase, Jeremy M. Shefner, Andrew McGarry, Brenda Thornell, Catherine Gladden, Michele Costigan, Padraig O’Suilleabhain, Frederick J. Marshall, Amy M. Chesire, Paul Deritis, Jamie L. Adams, Peter Hedera, Kelly Lowen, H. Diana Rosas, Amie L. Hiller, Joseph Quinn, Kellie Keith, Andrew P. Duker, Christina Gruenwald, Angela Molloy, Cara Jacob, Stewart Factor, Elaine Sperin, Danny Bega, Zsazsa R. Brown, Lauren C. Seeberger, Victor W. Sung, Melanie Benge, Sandra K. Kostyk, Allison M. Daley, Susan Perlman, Valerie Suski, Patricia Conlon, Matthew J. Barrett, Stephanie Lowenhaupt, Mark Quigg, Joel S. Perlmutter, Brenton A. Wright, Elaine Most, Guy J. Schwartz, Jessica Lamb, Rosalind S. Chuang, Carlos Singer, Karen Marder, Joyce A. Moran, John R. Singleton, Meghan Zorn, Paola V. Wall, Richard M. Dubinsky, Carolyn Gray and Carolyn Drazinic
    Safety and Tolerability of SRX246, a Vasopressin 1a Antagonist, in Irritable Huntington’s Disease Patients—A Randomized Phase 2 Clinical Trial
    Journal of Clinical Medicine.
    2020;
    9
    (3682)
    1-14.
    PubMed: PMC7696926
  • NN104 Primary Endpoint Publication

    Lyden P, Pryor KE, Coffey CS, Cudkowicz M, Conwit R, Jadhav A, Sawyer RN, Claassen J, Adeoye O, Song S, Hannon P, Rost NS, Hinduja A, Torbey M, Lee JM, Benesch C, Rippee M, Rymer M, Froehler MT, Haley EC, Johnson M, Yankey J, Magee K, Qidwai J, Levy H, Haacke EM, Fawaz M, Davis TP, Toga AQ, Griffin JH, Zlokovic BV, the NeuroNEXT Clinical Trials Network NN104 Investigators
    Final Results of the RHAPSODY Trial: A Multi-Center, Phase 2 Trial Using a Continual Reassessment Method to Determine the Safety and Tolerability of 3K3A-APC, A Recombinant Variant Human Activated Protein C, in Combination with Tissue Plasminogen Activ...
    Annals of Neurology.
    2019;
    85
    125-136.
  • NN101 Recruitment and Retention Manuscript

    Bartlett A, Kolb SJ, Kinglsey A, Swoboda KJ, Reyna SP, Sakonju A, Darras BT, Shell R, Kuntz N, Castro D, Iannaccone ST, Parsons J, Connolly AM, Chiriboga CA, McDonald C, Burnett BW, Werner K, Thangarajh M, Shieh PB, Finanger E, Coffey CS, Yankey JW, Cudkowicz ME, McGovern MM, McNeil ED, Arnold DW, Kissel JT, The NeuroNEXT Clinical Trial Network and on behalf of the NN101 SMA Biomarker Investigators.
    Recruitment & Retention Program for the NeuroNEXT SMA Biomarker Study: Super Babies for SMA!
    Contemporary Clinical Trials Communications.
    2018 September;
    11
    113-119.
    PubMed: PMC6072892
  • NN102 Primary Endpoint Publication

    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 DJ, Klinger E, Koepp M, Long JD, Natarajan S, Thornell B, Yankey J, Bermel RA, Debbins JP, Huang X, Jagodnik P, Lowe MK, 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 D, Flores A, Giesser BS, Goldman MD, Jubelt B, Lava N, Lynch SG, Moses H, Ontaneda D, Perumal JS, Racke M, Repobic P, Riler CS, Severson C, Shinnar S, Suski V, Weinstock-Guttman B, Yadav V, Zabeti A for the NN102/SPRINT-MS Trial Investigators
    Phase 2 Trial of Ibudilast in Progressive Multiple Sclerosis
    New England Journal of Medicine.
    2018 Aug 30;
    379
    (9)
    846-855.
    PubMed: PMC6172944
  • NN101 Motor Function Test Reliability Paper

    Krosschell KJ, Bosch M, Nelson L, Duong T, Lowes LP, Alfano LN, Benjamin D, Carry TB, Devine G, Kelley C, Gadekan R, Malkus EC, Pasternak A, Provance-Orr S, Roemeiser-Logan L, Nicorici A, Trussell D, Young SD, Fetterman JR, Montes J, Powers PJ, Quinones R, Quigley J, Coffey CS, Yankey JW, Bartlett AW, Kissel JT, Kolb SJ, NeuroNEXT Clinical Trial Network and on behalf of the NN101 SMA Biomarker Investigators.
    Motor Function Test Reliability During the NeuroNEXT Spinal Muscular Atrophy Infant Biomarker Study
    Journal of Neuromuscular Diseases.
    2018;
    5
    (4)
    509-521.
    PubMed: 30223401
  • Editorial accompanying NN101 SMA primary results publication

    Rutkove SB, Darras BT
    NeuroNEXT is at your service
    Annals of Neurology.
    2017 Dec.;
    82
    (6)
    857-858.
  • NN101 Primary Paper, "Natural History of Infantile-Onset Spinal Muscular Atrophy"

    Kolb SJ, Coffey CS, Yankey JW, Korsschell KP, Arnold WD, Rutkove SB, Swoboda KJ, Reyna SP, Sakonju A, Darras BT, Shell R, Kuntz N, Castro D, Parsons J, Connolly A, Chiriboga CA, McDonald C, Burnette B, Werner W, Thangarajh M, Shieh P, Finanger E, Cudkowicz M, McGovern MM, McNeil DE, Finkel R, Iannacone ST, Kaye E, Kingsley A, Renusch SR, McGovern VL, Wang X, Zaworski PG, Prior TW, Burghes A, Bartlett AHM, Kissel JT the NeuroNEXT Clinical Trial Network and on behalf of the NN101 SMA Biomarker Investigators.
    Natural History of Infantile-Onset Spinal Muscular Atrophy
    Annals of Neurology.
    2017 Dec.;
    82
    (6)
    883-891.
    PubMed: PMC5776712
  • NN104 Paper, "Selecting patients for intraarterial therapy in the context of a clinical trial for neuroprotection"

    Lyden P, Weymer S, Coffey C, Cudkowicz M, Berg S, O'Brien S, Fisher M, Haley EC, Khatri P, Saver J, Levine S, Levy H, Rymer M, Wechsler L, Jadhav A, McNeil E, Waddy S, Pryor K.
    Selecting patients for intraarterial therapy in the context of a clinical trial for neuroprotection.
    Stroke.
    2016;
    47
    (12)
    2979-2985.
    PubMed: PMC5134840
  • NN102 Paper, "Design, rationale, and baseline characteristics of the randomized double-blind phase II clinical trial of ibudilast in progressive multiple sclerosis"

    Fox RJ, Coffey CS, Cudkowicz ME, Gleason T, Goodman A, Klawiter EC, Matsuda K, McGovern M, Conwit R, Naismith R, Ashokkumar A, Bermel R, Ecklund D, Koepp M, Long J, Natarajan S, Ramachandran S, Skaramagas T, Thornell B, Yankey J, Agius M, Bashir K, Cohen B, Coyle P, Delgado S, Dewitt D, Flores A, Giesser B, Goldman M, Jubelt B, Lava N, Lynch S, Miravalle A, Moses H, Ontaneda D, Perumal J, Racke M, Repovic P, Riley C, Severson C, Shinnar S, Suski V, Weinstock-Gutman B, Yadav V, Zabeti A.
    Design, rationale, and baseline characteristics of the randomized double-blind phase II clinical trial of ibudilast in progressive multiple sclerosis.
    Contemporary Clinical Trials.
    2016;
    50
    166-177.
    PubMed: PMC5035622
  • NN101 Paper, "Baseline results of the NeuroNEXT spinal muscular atrophy infant biomarker study"

    Kolb SJ, Coffey CS, Yankey JW, Krosschell K, Arnold WD, Rutkove SB, Swoboda KJ, Reyna SP, Sakonju A, Darras BT, Shell R, Kuntz N, Castro D, Iannaccone ST, Parsons J, Connolly AM, Chiriboga CA, McDonald C, Burnette WB, Werner K, Thangarajh M, Shieh PB, Finanger E, Cudkowicz ME, McGovern MM, McNeil DE, Finkel R, Kaye E, Kingsley A, Renusch SR, McGovern VL, Wang X, Zaworski PG, Prior TW, Burghes AH, Bartlett A, Kissel JT; NeuroNEXT Clinical Trial Network and on behalf of the NN101 SMA Biomarker Investigators.
    Baseline results of the NeuroNEXT spinal muscular atrophy infant biomarker study.
    Annals of Clinical and Translational Neurology.
    2016;
    3
    (2)
    132-45.
    PubMed: PMC4748311
  • You May Have Worked on More Adaptive Designs Than You Think

    Coffey CS.
    You May Have Worked on More Adaptive Designs Than You Think
    Stroke.
    2015;
    46
    (2)
    e26-28.
    PubMed: PMC4308449
  • Central Institutional Review Board Review for an Academic Trial Network

    Kaufmann P, O'Rourke PP.
    Central Institutional Review Board Review for an Academic Trial Network
    Academic Medicine.
    2015;
    90
    (3)
    321-3.
    PubMed: PMC4859204
  • Ullman editorial in "Annals of Neurology" highlighting NeuroNEXT

    Ullman K.
    A Burst of speed for neurological research
    Annals of Neurology.
    2013;
    74
    (2)
    A7-8.
  • NeuroNEXT: accelerating drug development in Neurology

    Editorial
    NeuroNEXT: accelerating drug development in Neurology
    Lancet Neurology.
    2012;
    11
    (2)
    119.
  • Adaptive trial designs: A review of barriers and opportunities

    Kairalla JA, Coffey CS, Thomann MA, Muller KE.
    Adaptive trial designs: A review of barriers and opportunities
    Trials.
    2012;
    13
    145.
    PubMed: PMC3519822
  • Trial Networks Move Beyond Single-Disease Strategies

    Dolgin E.
    Trial Networks Move Beyond Single-Disease Strategies.
    Nat Med.
    2011;
    6
    (17(12))
    1525.