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8. Seven-Year Experience From the National Institute of Neurological Disorders and Stroke-Supported Network for Excellence in Neuroscience Clinical Trials.

Author

Cudkowicz, Merit, Chase, Marianne, Coffey, Christopher, Ecklund, Dixie, Thornell, Brenda, Lungu, Codrin, Mahoney, Katy, Gutmann, Laurie, Shefner, Jeremy, Staley, Kevin, Bosch, Michael, Foster, Eric, Long, Jeffrey, Bayman, Emine, Torner, James, Yankey, Jon, Peters, Richard, Huff, Trevis, Conwit, Robin, Shinnar, Shlomo, Patch, Donna, Darras, Basil, Ellis, Audrey, Packer, Roger, Marder, Karen, Chiriboga, Claudia, Moran, Joyce, Nikolov, Blagovest, Factor, Stewart, Seeley, Carole, Greenberg, Steven, Amato, Anthony, DeGregorio, Sara, Simuni, Tanya, Ward, Tina, Kissel, John, Kolb, Stephen, Bartlett, Amy, Quinn, Joseph, Keith, Kellie, Levine, Steven, Gilles, Nadege, Coyle, Patricia, Lamb, Jessica, Wolfe, Gil, Crumlish, Annemarie, Mejico, Luis, Iqbal, Muhammad, Bowen, James, Tongco, Caryl, Nabors, Louis, Bashir, Khurram, Benge, Melanie, Canamar, Catherine, Glauser, Tracy, Woo, Daniel, Molloy, Angela, Clark, Peggy, Vollmer, Timothy, Stein, Alexander, Barohn, Richard, Dimachkie, Mazen, Le Pichon, Jean-Baptiste, Benatar, Michael, Steele, Julie, Wechsler, Lawrence, Clemens, Paula, Amity, Christine, Holloway, Robert, Annis, Christine, Goldberg, Mark, Andersen, Mariam, Iannaccone, Susan, Smith, A, Singleton, J, Doudova, Mariana, Haley, E, Quigg, Mark, Lowenhaupt, Stephanie, Malow, Beth, Adkins, Karen, Clifford, David, Teshome, Mengesha, Connolly, Noreen, Oskarsson, Björn, Dobkin, Bruce, McDonald, Craig, Henricson, Erik, and Henchcliffe, Claire

Subjects
Clinical Trials as Topic, Humans, National Institute of Neurological Disorders and Stroke (U.S.), Nervous System Diseases, Neurology, Neurosciences, United States
Abstract

IMPORTANCE: One major advantage of developing large, federally funded networks for clinical research in neurology is the ability to have a trial-ready network that can efficiently conduct scientifically rigorous projects to improve the health of people with neurologic disorders. OBSERVATIONS: National Institute of Neurological Disorders and Stroke Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT) was established in 2011 and renewed in 2018 with the goal of being an efficient network to test between 5 and 7 promising new agents in phase II clinical trials. A clinical coordinating center, data coordinating center, and 25 sites were competitively chosen. Common infrastructure was developed to accelerate timelines for clinical trials, including central institutional review board (a first for the National Institute of Neurological Disorders and Stroke), master clinical trial agreements, the use of common data elements, and experienced research sites and coordination centers. During the first 7 years, the network exceeded the goal of conducting 5 to 7 studies, with 9 funded. High interest was evident by receipt of 148 initial applications for potential studies in various neurologic disorders. Across the first 8 studies (the ninth study was funded at end of initial funding period), the central institutional review board approved the initial protocol in a mean (SD) of 59 (21) days, and additional sites were added a mean (SD) of 22 (18) days after submission. The median time from central institutional review board approval to first site activation was 47.5 days (mean, 102.1; range, 1-282) and from first site activation to first participant consent was 27 days (mean, 37.5; range, 0-96). The median time for database readiness was 3.5 months (mean, 4.0; range, 0-8) from funding receipt. In the 4 completed studies, enrollment met or exceeded expectations with 96% overall data accuracy across all sites. Nine peer-reviewed manuscripts were published, and 22 oral presentations or posters and 9 invited presentations were given at regional, national, and international meetings. CONCLUSIONS AND RELEVANCE: NeuroNEXT initiated 8 studies, successfully enrolled participants at or ahead of schedule, collected high-quality data, published primary results in high-impact journals, and provided mentorship, expert statistical, and trial management support to several new investigators. Partnerships were successfully created between government, academia, industry, foundations, and patient advocacy groups. Clinical trial consortia can efficiently and successfully address a range of important neurologic research and therapeutic questions.

Published
2020

11. Immunopathogenesis

Author

Coyle, Patricia K., Tarsy, Daniel, Series Editor, Rizvi, Syed A., editor, Cahill, Jonathan F., editor, and Coyle, Patricia K., editor

Published
2020
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13. How Do I Approach the Evaluation and Treatment of Early Lyme Disease?

Author

Schutzer, Steven E. and Coyle, Patricia K.

Subjects
LYME disease diagnosis, LYME disease treatment, EARLY diagnosis, LYME disease
Abstract

The incidence and geographic spread of Lyme disease are increasing, and more than 476,000 new cases a year are estimated to occur in the United States. Therefore, many clinicians in North America will need to consider how to approach a patient with a concern for Lyme disease. This Curbside Consult addresses common clinical considerations, including discussion of signs of early Lyme disease, available laboratory tests, when to treat and with which antibiotics. [ABSTRACT FROM AUTHOR]

Published
2024
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15. Phase 2 Trial of Ibudilast in Progressive Multiple Sclerosis

Author

Fox, Robert J, Coffey, Christopher S, Conwit, Robin, Cudkowicz, Merit E, Gleason, Trevis, Goodman, Andrew, Klawiter, Eric C, Matsuda, Kazuko, McGovern, Michelle, Naismith, Robert T, Ashokkumar, Akshata, Barnes, Janel, Ecklund, Dixie, Klingner, Elizabeth, Koepp, Maxine, Long, Jeffrey D, Natarajan, Sneha, Thornell, Brenda, Yankey, Jon, Bermel, Robert A, Debbins, Josef P, Huang, Xuemei, Jagodnik, Patricia, Lowe, Mark J, Nakamura, Kunio, Narayanan, Sridar, Sakaie, Ken E, Thoomukuntla, Bhaskar, Zhou, Xiaopeng, Krieger, Stephen, Alvarez, Enrique, Apperson, Michelle, Bashir, Khurram, Cohen, Bruce A, Coyle, Patricia K, Delgado, Silvia, Dewitt, L Dana, Flores, Angela, Giesser, Barbara S, Goldman, Myla D, Jubelt, Burk, Lava, Neil, Lynch, Sharon G, Moses, Harold, Ontaneda, Daniel, Perumal, Jai S, Racke, Michael, Repovic, Pavle, Riley, Claire S, Severson, Christopher, Shinnar, Shlomo, Suski, Valerie, Weinstock-Guttman, Bianca, Yadav, Vijayshree, and Zabeti, Aram

Subjects
Neurosciences, Neurodegenerative, Brain Disorders, Clinical Trials and Supportive Activities, Autoimmune Disease, Multiple Sclerosis, Clinical Research, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Neurological, Adult, Atrophy, Brain, Depression, Diffusion Tensor Imaging, Disease Progression, Double-Blind Method, Female, Gastrointestinal Diseases, Headache, Humans, Male, Middle Aged, Multiple Sclerosis, Chronic Progressive, Phosphodiesterase Inhibitors, Pyridines, NN102/SPRINT-MS Trial Investigators, Medical and Health Sciences, General & Internal Medicine
Abstract

BackgroundThere are limited treatments for progressive multiple sclerosis. Ibudilast inhibits several cyclic nucleotide phosphodiesterases, macrophage migration inhibitory factor, and toll-like receptor 4 and can cross the blood-brain barrier, with potential salutary effects in progressive multiple sclerosis.MethodsWe enrolled patients with primary or secondary progressive multiple sclerosis in a phase 2 randomized trial of oral ibudilast (≤100 mg daily) or placebo for 96 weeks. The primary efficacy end point was the rate of brain atrophy, as measured by the brain parenchymal fraction (brain size relative to the volume of the outer surface contour of the brain). Major secondary end points included the change in the pyramidal tracts on diffusion tensor imaging, the magnetization transfer ratio in normal-appearing brain tissue, the thickness of the retinal nerve-fiber layer, and cortical atrophy, all measures of tissue damage in multiple sclerosis.ResultsOf 255 patients who underwent randomization, 129 were assigned to ibudilast and 126 to placebo. A total of 53% of the patients in the ibudilast group and 52% of those in the placebo group had primary progressive disease; the others had secondary progressive disease. The rate of change in the brain parenchymal fraction was -0.0010 per year with ibudilast and -0.0019 per year with placebo (difference, 0.0009; 95% confidence interval, 0.00004 to 0.0017; P=0.04), which represents approximately 2.5 ml less brain-tissue loss with ibudilast over a period of 96 weeks. Adverse events with ibudilast included gastrointestinal symptoms, headache, and depression.ConclusionsIn a phase 2 trial involving patients with progressive multiple sclerosis, ibudilast was associated with slower progression of brain atrophy than placebo but was associated with higher rates of gastrointestinal side effects, headache, and depression. (Funded by the National Institute of Neurological Disorders and Stroke and others; NN102/SPRINT-MS ClinicalTrials.gov number, NCT01982942 .).

Published
2018

16. The efficacy of cladribine tablets in CIS patients retrospectively assigned the diagnosis of MS using modern criteria: Results from the ORACLE-MS study

Author

Freedman, Mark S, Leist, Thomas P, Comi, Giancarlo, Cree, Bruce AC, Coyle, Patricia K, Hartung, Hans-Peter, Vermersch, Patrick, Damian, Doris, and Dangond, Fernando

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Neurodegenerative, Brain Disorders, Clinical Trials and Supportive Activities, Autoimmune Disease, Multiple Sclerosis, Neurosciences, Clinical Research, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Cladribine tablets, McDonald 2010 criteria, clinically isolated syndrome, conversion to clinically definite multiple sclerosis, early multiple sclerosis, efficacy, Epidemiology, Health services and systems
Abstract

BackgroundMultiple sclerosis (MS) diagnostic criteria have changed since the ORACLE-MS study was conducted; 223 of 616 patients (36.2%) would have met the diagnosis of MS vs clinically isolated syndrome (CIS) using the newer criteria.ObjectiveThe objective of this paper is to assess the effect of cladribine tablets in patients with a first clinical demyelinating attack fulfilling newer criteria (McDonald 2010) for MS vs CIS.MethodsA post hoc analysis for subgroups of patients retrospectively classified as fulfilling or not fulfilling newer criteria at the first clinical demyelinating attack was conducted.ResultsCladribine tablets 3.5 mg/kg (n = 68) reduced the risk of next attack or three-month confirmed Expanded Disability Status Scale (EDSS) worsening by 74% vs placebo (n = 72); p = 0.0009 in patients meeting newer criteria for MS at baseline. Cladribine tablets 5.25 mg/kg (n = 83) reduced the risk of next attack or three-month confirmed EDSS worsening by 37%, but nominal significance was not reached (p = 0.14). In patients who were still CIS after applying newer criteria, cladribine tablets 3.5 mg/kg (n = 138) reduced the risk of conversion to clinically definite multiple sclerosis (CDMS) by 63% vs placebo (n = 134); p = 0.0003. Cladribine tablets 5.25 mg/kg (n = 121) reduced the risk of conversion by 75% vs placebo (n = 134); p

Published
2017

17. Multi-institutional Study of Neurologic Outcomes in People with Multiple Sclerosis Who Are Treated with Immune Checkpoint Inhibitors for Oncologic Indications (PL4.004)

Author

Quinn, Carson, primary, Rajarajan, Prashanth, additional, Kopinsky, Hannah, additional, Wolf, Andrew, additional, De Camargo, Celeste Soares, additional, Gill, Alexander, additional, Murray, Joseph, additional, Probasco, John, additional, Galetta, Kristin, additional, Kantor, Daniel, additional, Coyle, Patricia, additional, Bhise, Vikram, additional, Alvarez, Enrique, additional, Conway, Sarah, additional, Bhattacharyya, Shamik, additional, and Kister, Ilya, additional

Published
2024
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18. B-Cell Depletion and Efficacy Outcomes of Ofatumumab Are Consistent Across Different Body Mass Index Categories: Insights from ASCLEPIOS I and II Trials (P9-6.002)

Author

Cross, Anne, primary, Hauser, Stephen, additional, Wiendl, Heinz, additional, Bar-Or, Amit, additional, Coyle, Patricia, additional, Montalban, Xavier, additional, De Seze, Jerome, additional, Fu, Haoyi, additional, Bhatt, Alit, additional, Boer, Ibolya, additional, and Kappos, Ludwig, additional

Published
2024
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21. Safety and efficacy of MD1003 (high-dose biotin) in patients with progressive multiple sclerosis (SPI2): a randomised, double-blind, placebo-controlled, phase 3 trial

Author

Reingold, Stephen, Duquette, Pierre, Derfuss, Tobias, Fazekas, Franz, Sormani, Maria Pia, Lisak, Robert P., Graves, Jennifer, Krieger, Stephen, Zabad, Rana K., Newsome, Scott, Barton, Joshua, MacDonell, Richard, Marriott, Mark, De Klippel, Nina, Laureys, Guy, Willekens, Barbara, Devonshire, Virginia, Freedman, Mark, Girard, J Marc, Giacomini, Paul, McKelvey, Roger, Selchen, Daniel, Vorobeychik, Galina, Witkowski, Ludivine, Ampapa, Radek, Preiningerova, Jana Lizrova, Meluzinova, Eva, Talab, Radomir, Vachova, Marta, Aktas, Orhan, Buttmann, Mathias, Birte, Elias-Hamp, Kuempfel, Tania, Friedemann, Paul, Rau, Daniela, Reifschneider, Gerd, Sokolowski, Piotr, Tumani, Hayrettin, Satori, Maria, Pozzilli, Carlo, Klosek, Agata, Koscielniak, Jozef, Waldemar, Fryze, Zajda, Malgorzata, Gonzalez, Rafael Arroyo, Ayuso, Guillermo Izquierdo, Sanchez, Victoria Fernandez, Guevara, Celia Oreja, Rodriguez, Jose Enrique Martinez, Montalban, Xavier, Ramio-Torrenta, Lluis, Brundin, Lou, Lycke, Jan, Terzi, Murat, Guadagno, Joe, Mahad, Don, Pace, Adrian, Schmierer, Klaus, Toosy, Ahmed, Webb, Stewart, Agius, Mark, Amezcua, Lilyana, Apperson, Michelle, Bagert, Bridget, Bandari, Daniel, Bernitsas, Evanthia, Calkwood, Jonathan, Carter, Jonathan, Cohen, Bruce, Conway, Devon, Cooper, Joanna, Corboy, John, Coyle, Patricia, Cree, Bruce, Freedman, Mitchel, Ford, Corey, Fox, Edward, Goldman, Myla, Greenberg, Benjamin, Kita, Mariko, Leist, Thomas, Lynch, Sharon, Miller, Aaron, Moses, Harold, Naismith, Robert, Picone, Mary Ann, Perminder, Bhatia, Rae-Grant, Alexander, Rammohan, Kottil, Reder, Anthony, Riley, Claire, Robertson, Derrick, Rowe, Vernon, Saidha, Shiv, Samkoff, Lawrence, Severson, Christopher, Smoot, Kyle, Stoll, Sharon, Trudell, Randall, Weinstock-Guttman, Bianca, Yathiraj, Sanjay, Cree, Bruce A C, Cutter, Gary, Wolinsky, Jerry S, Freedman, Mark S, Comi, Giancarlo, Giovannoni, Gavin, Hartung, Hans-Peter, Arnold, Douglas, Kuhle, Jens, Block, Valerie, Munschauer, Frederick E, Sedel, Frédéric, and Lublin, Fred D

Published
2020
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31. Effects of Ibudilast on MRI Measures in the Phase 2 SPRINT-MS Study

Author

Naismith, Robert T., Bermel, Robert A., Coffey, Christopher S., Goodman, Andrew D., Fedler, Janel, Kearney, Marianne, Klawiter, Eric C., Nakamura, Kunio, Narayanan, Sridar, Goebel, Christopher, Yankey, Jon, Klingner, Elizabeth, Fox, Robert J., Shinnar, Shlomo, Ontaneda, Daniel, Riley, Claire S., Perumal, Jai, Lava, Neil, Klawiter, Eric, Cohen, Bruce, Racke, Michael, Yadav, Vijayshree, Jubelt, Burk, WeinstockGutman, Bianca, Coyle, Patricia, Repovic, Pavle, Bashir, Khurram, Apperson, Michelle, Giesser, Barbara, Zabeti, Aram, Miravalle, Augusto, Lynch, Sharon, Delgado, Silvia, Suski, Valerie, Goodman, Andrew, Flores, Angela, DeWitt, Dana, Goldman, Myla, Moses, Harold, Naismith, Robert, Peng, Qi, Sakaie, Ken, Jambawalikar, Sachin, Dyke, Jonathan P., Kitajima, Hiroumi, Panych, Lawrence, Witzel, Thomas, Parrish, Todd, Layman, Rick, Yang, Xiangyu, Yee, Seonghwan, Shah, Dhaval, Button, Terry, Williams, Tony, Buonocore, Mike, Tanase, Costin, Ellingson, Ben, GaskillShipley, Mary, Morton, Ray, Brown, Mark, Lee, Phil, Pattany, Pradip, Hetherington, Hoby, Zhang, Jianhui, Varghese, Shijn, Lee, James, Mugler, John P., Price, Ron, Thomas, Betsy, Welch, Mary, Liff, Jeremy, Smith, Andrew, Ian, Rossman, Vargas, Wendy, Cioroiu, Comana, Nealon, Nancy, Vargas, Diana, Cook, Calli, Baharnoori, Moogeh, Reda, Haatem, Mateen, Farrah, Patel, Kevin, Kay-Stacey, Margaret, Kisanuki, Yasushi, Brett, Alldredge, Bogda, Christine, Mass, Michele, Kim, Edward, Duleep, Anuradha, Grosso, Megan, Bucello, Meg, McLinkskey, Nancy, Mayadev, Angeli, Peiqing, Qian, Meador, William, Richman, David, Dorsch, Andrew, Nygren, Kristin, Obeidat, Ahmed, Wall, Anastacia, Hammond, Nancy, Andersen, Heather, Mittal, Manoj, Tornes, Leticia, Lizarraga, Alexis, Zaydan, Islam, Hyland, Megan, Munoz, Shanan, Wright, Katy, Smith, Gordon, Bruen, Denise, Brenton, James Nicholas, Pawate, Siddharama, Sriram, Subramaniam, Oddis, Kerry, Scheid, Eileen, Thayer, William, Duodova, Mariana, Keller, Margaret, Scott, Jennifer, and Teshome, Mengesha

Published
2021
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46. Evolving expectations in the management of MS: Emerging therapies for relapsing-remitting multiple sclerosis raise the bar from the current therapeutic goal of minimal disease activity to none at all

Author

Coyle, Patricia K.

Subjects
B cells -- Health aspects, Recurrence (Disease) -- Care and treatment -- Development and progression -- Health aspects, Medical research -- Health aspects, Multiple sclerosis -- Care and treatment -- Development and progression -- Health aspects, Health
Abstract

Today's characterizations of multiple sclerosis (MS) phenotypes include both disease activity (based on the clinical relapse rate and imaging findings) and disease progression. Relapsing-remitting MS (RRMS), clinically isolated syndrome (CIS), [...]

Published
2017

50. Improvement in time to multiple sclerosis diagnosis: 25-year retrospective analysis from New York State MS Consortium (NYSMSC).

Author

Jakimovski, Dejan, Kavak, Katelyn S, Zakalik, Karen, Coetzee, Timothy, Gottesman, Malcolm, Coyle, Patricia K, Zivadinov, Robert, and Weinstock-Guttman, Bianca

Subjects
MULTIPLE sclerosis, RETROSPECTIVE studies, DIAGNOSIS, EARLY diagnosis
Abstract

Judicious multiple sclerosis (MS) diagnosis and early start of disease modifying therapy significantly improves long-term disability outcomes in persons with MS (pwMS). Retrospective analysis based on 25-year New York State MS Consortium (NYSMSC) data determined the effect of changes in the respective diagnostic criteria in shortening the time between symptom onset to MS diagnosis. Based on 9378 current and historical MS cases, there was a significant decrease in time to diagnosis in pwMS from 1982–2001 to >2017 periods (average 4.2 vs. 1.1 years, p < 0.001). Additional improvements and better implementation of the MS diagnostic criteria can further decrease the diagnosis lag. [ABSTRACT FROM AUTHOR]

Published
2023
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