Publications

Publications by Date

  • 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…

    PubMed:
  • NN101 Recruitment and Retention Manuscript: “Recruitment & Retention Program for the NeuroNEXT SMA Biomarker Study: Super Babies for SMA! Contemporary Clinical Trials Communication”

    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!

    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

    PubMed: PMC6172944
  • NN101: “Motor Function Test Reliability During the NeuroNEXT Spinal Muscular Atrophy Infant Biomarker Study”

    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

    PubMed: 30223401
  • NN101 Primary Manuscript: “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

    PubMed: PMC5776712
  • Editorial accompanying NN101 SMA primary results publication

    Rutkove SB, Darras BT

    NeuroNEXT is at your service

    PubMed:
  • 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.

    PubMed: PMC4748311
  • 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.

    PubMed: PMC5035622
  • 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.

    PubMed: PMC5134840
  • 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

    PubMed: PMC4859204