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1. Posterior Cortical Atrophy: Characteristics From a Clinical Data Registry

Author

Jennifer J. Olds, William L. Hills, Judith Warner, Julie Falardeau, Lori Haase Alasantro, Mark L. Moster, Robert A. Egan, Wayne T. Cornblath, Andrew G. Lee, Benjamin M. Frishberg, Roger E. Turbin, David M. Katz, John A. Charley, and Victoria S. Pelak

Subjects
posterior cortical atrophy, Benson's syndrome, higher-order visual dysfunction, Alzheimer's disease, neuro-ophthalmology, patient registry, Neurology. Diseases of the nervous system, RC346-429
Abstract

Background: Posterior cortical atrophy (PCA) is a neurodegenerative syndrome that presents with higher-order visual dysfunction with relative sparing of memory and other cognitive domains, and it is most commonly associated with Alzheimer's disease pathology. There is a lack of data regarding the presentation of PCA to non-cognitive specialists. Therefore, we collected clinical data from neuro-ophthalmologists regarding the presentation of PCA to their practices and compared data to published cohorts and a published survey of cognitive specialists.Methods: Members of the North American Neuro-Ophthalmology Society Listserv (NANOSnet) were invited to complete an online, retrospective, chart-review data-entry survey regarding their patients with PCA, and REDCap was used for data collection.Results: Data for 38 patients were entered by 12 neuro-ophthalmologists. Patient mean age at presentation was 67.8 years, and 74% of patients were women. Difficulty reading was reported at presentation by 91% of patients, and poor performance on color vision, stereopsis, and visual field testing (performed reliably by 36/38 patients) were common findings. Most patients who were treated were treated with donepezil and/or memantine.Conclusions: Compared to published data from cognitive specialists, patients presenting to neuro-ophthalmology with PCA were more likely to be older and female and have a reading complaint. Reliable visual field testing was the norm with homonymous defects in the majority of patients. The neuro-ophthalmologist plays an important role in diagnosing PCA in older adults with unexplained visual signs and symptoms, and future studies of PCA should involve multiple specialists in order to advance our understanding of PCA and develop effective treatments.

Published
2020
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2. Real-World Evidence for Control of Chronic Migraine Patients Receiving CGRP Monoclonal Antibody Therapy Added to OnabotulinumtoxinA: A Retrospective Chart Review

Author

Ashley Iannone, Benjamin M. Frishberg, Larisa Yedigarova, Aubrey Manack Adams, Andrew M. Blumenfeld, Gary Schneider, and Jack Schim

Subjects
medicine.medical_specialty, Constipation, Combination therapy, business.industry, Type A botulinum toxins, Migraine headache, Review, Calcitonin gene-related peptide, Chronic daily headache, medicine.disease, CGRP receptor, Anesthesiology and Pain Medicine, Chronic Migraine, Migraine, Tolerability, Internal medicine, Chronic headache, medicine, Neurology (clinical), medicine.symptom, Adverse effect, business, Monoclonal antibody therapy, Preventive treatment
Abstract

Introduction Combination use of onabotulinumtoxinA and calcitonin gene–related peptide (CGRP) monoclonal antibodies (mAbs) has the potential to be more effective than either therapy alone for migraine prevention. Methods This retrospective, longitudinal chart review included adults with chronic migraine treated at one clinical site with ≥ 2 consecutive cycles of onabotulinumtoxinA and ≥ 1 month of subsequent combination treatment with CGRP mAbs. Charts at time of mAb prescription (baseline) and up to four visits ~ 3, 6, 9, and 12 months post-baseline were reviewed for safety, tolerability, and outcome measures (monthly headache days [MHDs], headache intensity, and migraine-related disability [MIDAS]). Results Of 300 charts reviewed, 257 patients met eligibility criteria (mean age: 50 years; 82% women). Average headache frequency was 21.5 MHDs before initiation of onabotulinumtoxinA and 12.1 MHDs before adding CGRP mAb therapy. Prescribed mAbs were erenumab (78%), fremanezumab (6%), and galcanezumab (16%). Over the entire study, patients discontinued CGRP mAb more frequently than onabotulinumtoxinA (23 vs. 3%). Adverse events occurred in 28% of patients, most commonly constipation (9%). Compared with onabotulinumtoxinA alone (baseline), MHDs decreased significantly at all visits (mean decrease: 3.5–4.0 MHDs over ~ 6–12 months of combination treatment); 45.1% of patients had clinically meaningful improvement in migraine-related disability (≥ 5-point reduction in MIDAS score) after ~ 6 months. Conclusions In this real-world study, combination treatment with onabotulinumtoxinA and CGRP mAbs was well tolerated, with no new safety signals identified, and was associated with additional clinically meaningful benefits. More real-world and controlled trials should be considered to further assess safety and potential benefits of combination treatment. Video abstract: Real-world data suggests that CGRP inhibitors improve onabotulinumtoxinA efficacy for chronic migraine (MP4 20,067 kb) Supplementary Information The online version contains supplementary material available at 10.1007/s40122-021-00264-x.

Published
2021

4. Stem cell implants show promise in chronic traumatic brain injury

Author

Laroslav Zinkevych, Dai Chida, Alan Weintraub, Yasuaki Karasawa, Bijan Nejadnik, Daniel C. Lu, Hajime Nakamura, David O. Okonkwo, Masahito Kawabori, Takehiko Kaneko, Neil E. Schwartz, Susan Paadre, Jefferson W. Chen, Achal S. Achrol, Benjamin M. Frishberg, Steven C. Cramer, Takao Yasuhara, Douglas Kondziolka, Jun Suenaga, Peter McAllister, Anthony H. Stonehouse, Gary K. Steinberg, Damien Bates, Ihor Semeniv, Hideaki Imai, and R. Mark Richardson

Subjects
0301 basic medicine, Randomization, Physical Injury - Accidents and Adverse Effects, Traumatic brain injury, Population, Clinical Trials and Supportive Activities, Clinical Sciences, MEDLINE, Traumatic Brain Injury (TBI), Bioinformatics, Mean difference, Article, Cell therapy, 03 medical and health sciences, Cellular and Molecular Neuroscience, 0302 clinical medicine, Injury - Trauma - (Head and Spine), Clinical Research, Medicine, In patient, Adverse effect, education, Traumatic Head and Spine Injury, education.field_of_study, Neurology & Neurosurgery, business.industry, Neurosciences, Interim analysis, medicine.disease, Brain Disorders, 030104 developmental biology, Anesthesia, Injury (total) Accidents/Adverse Effects, Cognitive Sciences, Neurology (clinical), Patient Safety, Stem cell, Injury - Traumatic brain injury, business, 030217 neurology & neurosurgery
Abstract

ObjectiveTo determine whether chronic motor deficits secondary to traumatic brain injury (TBI) can be improved by implantation of allogeneic modified bone marrow–derived mesenchymal stromal/stem cells (SB623).MethodsThis 6-month interim analysis of the 1-year double-blind, randomized, surgical sham–controlled, phase 2 Stem Cell Therapy for Traumatic Brain Injury (STEMTRA) trial (NCT02416492) evaluated safety and efficacy of the stereotactic intracranial implantation of SB623 in patients with stable chronic motor deficits secondary to TBI. Patients in this multicenter trial (n = 63) underwent randomization in a 1:1:1:1 ratio to 2.5 × 106, 5.0 × 106, or 10 × 106 SB623 cells or control. Safety was assessed in patients who underwent surgery (n = 61), and efficacy was assessed in the modified intent-to-treat population of randomized patients who underwent surgery (n = 61; SB623 = 46, control = 15).ResultsThe primary efficacy endpoint of significant improvement from baseline of Fugl-Meyer Motor Scale score at 6 months for SB623-treated patients was achieved. SB623-treated patients improved by (least square [LS] mean) 8.3 (standard error 1.4) vs 2.3 (standard error 2.5) for control at 6 months, the LS mean difference was 6.0 (95% confidence interval 0.3–11.8, p = 0.040). Secondary efficacy endpoints improved from baseline but were not statistically significant vs control at 6 months. There were no dose-limiting toxicities or deaths, and 100% of SB623-treated patients experienced treatment-emergent adverse events vs 93.3% of control patients (p = 0.25).ConclusionsSB623 cell implantation appeared to be safe and well tolerated, and patients implanted with SB623 experienced significant improvement from baseline motor status at 6 months compared to controls.ClinicalTrials.gov Identifier:NCT02416492.Classification of EvidenceThis study provides Class I evidence that implantation of SB623 was well tolerated and associated with improvement in motor status.

Published
2021

5. Benefits of eculizumab in AQP4+ neuromyelitis optica spectrum disorder: Subgroup analyses of the randomized controlled phase 3 PREVENT trial

Author

Jacqueline Palace, Dean M. Wingerchuk, Kazuo Fujihara, Achim Berthele, Celia Oreja-Guevara, Ho Jin Kim, Ichiro Nakashima, Michael Levy, Murat Terzi, Natalia Totolyan, Shanthi Viswanathan, Kai-Chen Wang, Amy Pace, Marcus Yountz, Larisa Miller, Róisín Armstrong, Sean Pittock, Daniel Julio Muñoz, Jorge David Amor, Carolina Bocchiardo, Julieta Iourno Danielle, Alfredo Laffue, Carolina Daniela Diaz Obregon, Maria Fernanda Paez, Roberto Martin Perez, Viviana Ana Maria Rocchi, Loreley Deborah Teijeiro, Jesica Gómez, Andres Maria Villa, Florencia Aguirre, Victoria Carla Fernández, Ramon F. Goicoechea, Luciana Melamud, Ana Stillman, Mariana de Virgiliis, Fatima Pagani Cassara, Marta Cordoba, Maria Teresa Gutierrez, Mariana Ingolotti, Natalia Larripa, Anahi Lupinacci, Josefina Arroyo, Alejandra Romano, Mariana Foa Torres, Carlos Héctor Ballario, Ana Elisa Chiesa, Hernán Gustavo Gómez, Hernán Gabriel Lattini, Carolina Natalia Mainella, Gisel Edith Bolner, María Soledad Eschoyez, Simon Andrew Broadley, Saman Heshmat, Arman Sabet, Andrew Swayne, Susan Freeman, Sofia Jimenez Sanchez, Neil Shuey, Linda Dalic, Ann French, Guru Kuma, Joshua Laing, Lai Yin Law, Jennifer MacIntyre, Andrew Neal, Christopher Plummer, Prashanth Ramachandran, Leslie Sedal, Ian Wilson, Antony Winkel, Wenwen Zhang, Tina Chen, Rani Watts, Michael Barnett, Joshua Barton, Heidi Beadnall, Justin Garber, Todd Andrew Hardy, Benjamin Trewin, Marinda Taha, Deleni Walters, Federico Arturo Silva Sieger, Nhora Patricia Ruiz Alfonso, Anna Maria Pinzon Camacho, Alexander Pabón Moreno, Jorge Armando Castellanos Prad, Adriana Paola Duarte Rueda, Tatiana Castillo, Karol Melissa Castillo Gonzalez, Martha Yolanda Moreno Pico, Judith Castill, Mario Habek, Ivan Adamec, Barbara Barun, Luka Crnosija, Tereza Gabelic, Petra Nytrova, Eva Krasulova, Jana Pavlickova, Michaela Tyblova, Jana Zubkova, Thor Petersen, Gro Helen Dale, Peter Vestergaard Rasmussen, Morten Stilund, Kristina Bacher Svendsen, Vivi Brandt, Nicolas Collongues, Marie-Celine Fleury, Laurent Kremer, Sandrine Bendele, Valérie Neff, Ricarda Diem, Michael Platten, Anne Berberich, Jonabelle Jansen, Hannah Jaschoneck, Brigitte Wildemann, Ursula Aures, Tanja Brandenburger, Tanja Haut, Maria-Lourdes Treceno Fernández, Lilian Aly, Kirsten Brinkhoff, Dorothea Buck, Daniel Golkowski, Mirjam Hermisson, Muna-Miriam Hoshi, Miriam Kaminski, Markus Christian Kowarik, Helena Kronsbein, Klaus Lehmann-Horn, Viola Maria Pongratz, Andreas Schweiker, Lisa-Ann Leddy, Silvia Mueller, Kim Obergfell, Marion Wanka, Uwe Klaus Zettl, Jan Klinke, Micha Loebermann, Stefanie Meister, Florian Rimmele, Alexander Winkelmann, Ina Schroeder, Alexander Yuk-Lun Lau, Lisa Wing-Chi Au, Florence Sin-Ying Fan, Vincent Hing-Lung Ip, Karen Ka-Yan Ma, Sze-Ho Ma, Vincent Chung-Tong Mok, Cheryl Chung-Kwan Au, Pauline Wing-Lam Kwan, Francesco Patti, Andrea Salvatore Caramma, Clara Grazia Chisari, Salvatore Lo Fermo, Silvia Messina, Maria Projetto, Cinzia Caserta, Alessandro Filla, Teresa Costabile, Chiara Pane, Francesco Sacca, Angela Marsili, Giorgia Puorro, Roberto Bergamaschi, Eliana Berra, Giulia Mallucci, Cinzia Fattore, Claudio Gasperini, Simonetta Galgani, Shalom Haggiag, Serena Ruggieri, Claudio Vento, Esmeralda Maria Quartuccio, Carlo Pozzilli, Valeria Teresa Barletta, Giovanna Borriello, Laura De Giglio, Fabiana Marinelli, Miriam Tasillo, Alessandra Amadori, Mariano Fischetti, Flavia Gurreri, Masahiro Mori, Hiroki Masuda, Ryohei Ohtani, Yukari Sekiguchi, Tomohiko Uchida, Akiyuki Uzawa, Hiromi Ito, Emi Kabasawa, Yoko Kaneko, Takuya Matsushita, Dai Matsuse, Hiroyuki Murai, Shintaro Hayashi, Katsuhisa Masak, Hidenori Ogata, Koji Shinoda, Taira Uehara, Mitsuru Watanabe, Hiroo Yamaguchi, Ryo Yamasaki, Tomomi Yonekawa, Maki Jingu, Makiko Nagano, Yumiko Nakamura, Yoshiko Sano, Manabu Araki, Youwei Lin, Madoka Mori, Yohei Mukai, Terunori Sano, Wakiro Sato, Naoya Gogun, Yuriko Maeda, Asami Nishimoto, Sachiko Tsukamoto, Ritsuko Yanagi, Takahiko Saida, Shinichi Nakamura, Tetsuya Nasu, Kyoko Saida, Yuko Shikata, Yoshimi Kodani, Megumi Saeki, Yukako Sawada, Hiroo Yoshikawa, Takashi Kimura, Masamitsu Nishi, Shun Sakamoto, Shinichiro Ukon, Shohei Watanabe, Saori Ebisuya, Nami Kimura, Manami Matsuura, Yukie Morisaki, Yoshiko Muroi, Kuniko Onishi, Ikuko Oshima, Yuki Washino, Tomomi Yamashita, Tatsuro Misu, Kimihiko Kaneko, Masaaki Kato, Hiroshi Kuroda, Kazuhiro Kurosawa, Shuhei Nishiyama, Hirohiko Ono, Yoshiki Takai, Keiko Abe, Hitomi Hoshi, Mari Jinushi, Azusa Oyama, Motonari Sakuma, Yuko Sawada, Satoru Ishibashi, Takanori Yokota, Yoichiro Nishida, Kokoro Ozaki, Nobuo Sanjo, Nozomu Sato, Fuki Denno, Haruko Hiraki, Yumi Matsubara, Takashi Kanda, Masaaki Abe, Masaya Honda, Motoharu Kawai, Michiaki Koga, Toshihiko Maeda, Junichi Ogasawara, Masatoshi Omoto, Yasuteru Sano, Ryota Sato, Fumitaka Shimizu, Hideki Arima, Sachie Fukui, Yoshiko Ishikawa, Tomoko Koyama, Shigemi Shimose, Hirokazu Shinozaki, Masanori Watanabe, Sachi Yasuda, Chieko Yoshiwaka, Suffian Adenan, Mohd Azman M Aris, Ahmad Shahir bin Mawardi, Muhammad Al Hafiz Adnan, Nanthini Munusamy, Siti Nur Omaira Razali, Punitha Somasundram, Jae Won Hyun, In Hye Jeong, Su-Hyun Kim, Hyun-June Shin, Ji Sung Yoo, HyunMin Jang, AeRan Joung, Byung-Jo Kim, Seol-Hee Baek, Jung Bin Kim, Yoo Hwan Kim, Yong Seo Koo, Chan Nyoung Lee, Hung Youl Seok, Jinhee Hwang, Sung Min Kim, So Hyun Ahn, Kyomin Choi, Seok-Jin Choi, Jun-Soon Kim, Young Nam Kwon, Je-Young Shin, Hyeonju Kwon, Byoung Joon Kim, Eun Bin Cho, Hye-Jin Cho, Misong Choi, DongSun Kim, Ju Hyeon Kim, SeungJu Ki, Hye Lim Lee, Kwang-Ho Lee, Ju-Hong Min, Ji-Hyung Park, Jinmyoung Seok, Eunhwa Choi, Sang Ae Park, Seung Min Kim, Ha-Neul Jeong, Bong Jeongbin, Jin Woo Jung, Seung Woo Kim, Yool-hee Kim, Hyung Seok Lee, Ha Young Shin, Yeon Jung, Min Jung Kim, Nou Ri Lee, MiJu Shin, Farit A Khabirov, Lyudmila Averyanova, Natalya Babicheva, Eugenii Granatov, Sergey Kazarov, Timur Khaybullin, Alexander Rogozhin, Dmitry V Pokhabov, Vladislav Abramov, Anastasia Amelina, Yulia Nesteroca, Tatyana Bozhenkina, Aleksey N Boyko, Elena G Demyan, Inessa Khoroshilova, Mikhail Melnikov, Ekaterina V Popova, Svetlana N Sharanova, Sergey G Shchur, Denis V Sazonov, Larisa Babenko, Elena Bayandina, Asya Yarmoschuk, Victor A Baliazin, Elena Baliazina, Elena Budaeva, Irina Chernikova, Zoya Goncharova, Vladimir Krasnov, Marina Myatleva, Olga V. Rodionova, Iuliana Samulyzhko, Alla A. Timofeeva, Sabas Boyero Duran, Maria Mar Mendibe Bilbao, Irene Diaz Cuervo, Jose Maria Losada Domingo, Amaia Gonzalez Eizaguirre, Jose Eulalio Barcena Llona, Roberto Valverde Moyano, Carmen Bahamonde, Fernando Sanchez Lopez, Raquel Pinar Morales, Eduardo Agüera Morales, Carmen Bahamonde Roman, Juan Jose Ochoa Sepulveda, Maria del Carmen Blanco Valero, Nazaret Pelaez Viña, Cristina Conde Gavilan, Ana Maria Jover Sanchez, Sara Vila Bedmar, Nuria Gonzalez Garcia, Aida Orviz Garcia, Ines Gonzalez-Suarez, Elena Miñano Guillamon, Miguel Kawiorski, Elena Guerra Schulz, Alba Garcia Alonso, Francisco Jesus Lopez Perez, Marta Palacios Sarmiento, Guillermo Izquierdo Ayuso, Guillermo Navarro Mascarell, Cristina Paramo Camino, Asuncion Varas Garcia, Yaiza Montserrat Mendoza, Veronica Ines Vargas Muñoz, Patricia Torres Tonda, Ching-Piao Tsai, Jiu-Haw Yin, Mei-Jung Chen, Shan-Ni Li, Fei-Ti Wang, Suwat Srisuwannanukorn, Thanatat Boonmongkol, Duangporn Borisutbuathip, Duangkamol Singwicha, Krittika Siritanan, Chidchanoke Thearapati, Kwanmuang Sornda, Metha Apiwattanakul, Saharat Aungsumart, Narupat Suanprasert, Kaona Suksuchano, Nittaya Parkinsee, Kongkiat Kulkantrakorn, Praween Lolekha, Artit Potigumjon, Puchit Sukphulloprat, Dararat Suksasunee, Chankawee Komaratat, Sunattana Luangtong, Arkhom Arayawichanont, Phanpaphon Konpan, Nathapol Riablershirun, Thaddao Wiroteurairuang, Panadda Jantaweesirirat, Aslı Kurne, Irem Erkent, Ebru Bekircan Kurt, Ezgi Saylam, Yagmur Caliskan, Gulsah Orsel, Yahya Celik, Canan Celebi, Aslan Tekatas, Tugce Banbal, Gulsen Akman Demir, Burcu Altunrende, Zeliha Matur, Baris Topcular, Tules Elmas, Aysenur Gulo, Selin Ozdemir, Cansu Ozkoklesen, Mahinur Ozturk, Mertkan Yanik, Elif Yildirim, Melih Tutuncu, Ayse Altintas, Abdulsamet Cam, Ayse Deniz Elmali, Sabahattin Saip, Aksel Siva, Uygur Tanrıverdi, Ugur Uygunoglu, Sinem Caliskan, Pinar Gulo, Esra Kozig, Sakine Sakiz, Ihsan Sukru Sengun, Egemen Idiman, Rahmi Tumay Ala, Duygu Arslan, Utku Bulut, Yasemin Karakaptan, Derya Kaya, Zaur Mehdiyev, Bengu Balkan, Berfu Kuku, Mujgan Ozhun, Celal Tuga, Muzeyyen Ugur, Husnu Efendi, Sena Destan Bunul, Hakan Cavus, Yunus Emre Gorke, Ayse Kutlu, Seda Ozturk, Cansu Egilmez Sarikaya, Gulsah Becerikli, Cansu Semiz, Ozlem Tun, Sehriban Ayer, Musa Kazim Onar, Mehlika Berra Ozberk, Sedat Sen, Tugce Kirbas Cavdar, Adife Veske, Cavit Boz, Didem Altiparmak, Cigdem Ozen Aydin, Sibel Gazioglu, Duygu Bekircan, Anu Jacob, Heike Arndt, Liene Elsone, Shahd Hassan Mahmoud Hamid, Daniel Hugh Whittam, Martin Wilson, Imelda O'Brien, Maria Isabel da Silva Leite, Pedro Maria Rodriguez Cruz, Damian Robert Jenkins, George Tackley, Ana Cavey, Rosie Everett, Joy Hodder, Abigail Koelewyn, Ellen Mowry, Walter Royal, Robert Shin, Christopher Bever, Daniel Harrison, Horea Rus, Wei Zheng, Karen Callison, Kerry Naunton, Benjamin M Frishberg, Andrew M Blumenfeld, Andrew Inocelda, Kalyani Korabathina, Michael Lobatz, Melissa M Mortin, Irene J Oh, Jay H Rosenberg, Mark Sadoff, Gregory A Sahagian, Anchi Wang, Yasmin Camberos, Guadalupe Sanchez, Estela Soto, Jacqueline A Nicholas, Aaron Boster, Geoffrey Eubank, Katy Groezinger, Meghan Lauf, Annette F Okai, Rashedul Hasan, Chaouki Khoury, Victoria Stokes, Stacey Clardy, Melissa Cortez, John Greenlee, John Rose, Mateo Paz Soldan, Amanda Emett, Lawanda Esquibel, Lilly Fagatele, Ka-Ho Wong, James C Stevens, Thomas M Banas, Marlene C Bultemeyer, Andrea Haller, Natalie Manalo, Keri Aeschliman, Debi Kocks, Michael Racke, Aaron Lee Boster, Michelle Bowman, Jaime Imitola, Yasushi Kisanuki, Misty Green, Stephanie Scarberry, Sharon G Lynch, Heather S Anderson, Gary S Gronseth, Nancy E Hammond, Yasir N Jassam, Manoj K Mittal, Muhammed M Nashatizadeh, Nicholas Levine, Lisa Schmidt, Jill Sibley, Vonda Whitley, James Winkley, Timothy Coleman, Gregory Cooper, Stephanie Sheffield, Keri Turner, Dana Galloway, Robert S Tillett, Geeta A Ganesh, Brian M Plato, Tad D Seifert, Diana Godwin, Deborah Lockridge, Kottil W Rammohan, William A Sheremata, Silvia Delgado, Jose Gonzalez, Alexis Lizarraga, Janice Maldonado, Melissa Ortega, Leticia Tornes, Yanet Babcock, Osmara Cailam, Yesica Campos, Irlisse Couvertier, Bettina Daneri, Jeremy Deni, Jeffrey Hernandez, Tatiana Jaramillo, Tenita Morris, Daniel Nobel, Anjelis Oliveira, Reshma Richardson, Gloria Rodriguez, Ana Romero, Carlos Sandova, Ruta Sawant, Lissett Tueros, Eric S Zetka, Chao Zheng, Daniel H Jacobs, Constance Easterling, Jennifer Fairbank, Revathi Iyengar, Mark Klafter, Justin Lindquist, Ahmed H Sadek, Elizabeth Carmona Toro, Navin Verma, Brigith Patino Castro, Nadia Sukhraj-Singh, Joseph Berger, Eric Williamson, Salim Chahin, Dina Jacobs, Clyde Markowitz, Jessica Dobbins, Lauren Mace, Maria Martin, Ashley Pinckney, Amber Roberts, Islam Zaydan, Galen W Mitchell, Rock A Heyman, Ryan L Orie, Valerie R Suski, Kerry Oddis, Darlene Punjack, Eoin Flanagan, Avi Gadoth, Andrew McKeon, W Oliver Tobin, Anastasia Zekeridou, Katie Dunlay, Jessica Sagen, Jonathan L Carter, Bachir Estephan, Brent P Goodman, Charlene R Hoffman Snyder, Andrea Francone, Irene Galasky, Martha Thomas, Pavle Repovic, James Bowen, Angeli Mayadev, Peiqing Qian, Yuriko Courtney, Lauren Lennox, Robert Thomas Naismith, Anne Haney Cross, Emily Evans, Erin E Longbrake, Megan E Orchard, Gregory F Wu, Linda Heinrich, Susan Sommers, Faria Amjad, Erika Mitchell, Carlos Mora, Bethany Schreiber, Carlo Tornatore, Alexis Carlson, Sacha McCarthy, and Alexandria Oliver

Subjects
Adult, medicine.medical_specialty, Population, Placebo, Antibodies, Monoclonal, Humanized, 03 medical and health sciences, Complement inhibitor, 0302 clinical medicine, Internal medicine, medicine, Humans, 030212 general & internal medicine, education, Aquaporin 4, education.field_of_study, Neuromyelitis optica, business.industry, Neuromyelitis Optica, General Medicine, Eculizumab, medicine.disease, Comorbidity, ddc, Neurology, Concomitant, Rituximab, Neurology (clinical), business, 030217 neurology & neurosurgery, medicine.drug
Abstract

Background Antibodies to the aquaporin-4 (AQP4) water channel in neuromyelitis optica spectrum disorder (NMOSD) are reported to trigger the complement cascade, which is implicated in astrocyte damage and subsequent neuronal injury. The PREVENT study demonstrated that the terminal complement inhibitor eculizumab reduces adjudicated relapse risk in patients with anti-AQP4 immunoglobulin G-positive (AQP4+) NMOSD. The objective of this analysis was to evaluate the efficacy of eculizumab in reducing relapse risk and its safety in AQP4+ NMOSD across clinically relevant subgroups in PREVENT. Methods In the randomized, double-blind, time-to-event, phase 3 PREVENT trial, 143 adults received eculizumab (maintenance dose, 1200 mg/2 weeks) or placebo (2:1), with stable-dose concomitant immunosuppressive therapy (IST) permitted (except rituximab and mitoxantrone). Post hoc analyses of relapses and adverse events were performed for prespecified and post hoc subgroups based on concomitant IST and prior rituximab use, demographic and disease characteristics, and autoimmune comorbidity. Results The significant reduction in relapse risk observed for eculizumab versus placebo in the overall PREVENT population was consistently maintained across subgroups based on concomitant IST and previous rituximab use, age, sex, region, race, time since clinical onset of NMOSD, historical annualized relapse rate, baseline Expanded Disability Status Scale score, and history of another autoimmune disorder. The serious infection rate was lower with eculizumab than placebo regardless of rituximab use in the previous year, concomitant IST use, or history of another autoimmune disorder. Conclusion Across a wide range of clinically relevant AQP4+ NMOSD patient subgroups in PREVENT, eculizumab therapy was consistently effective versus placebo in reducing relapse risk, with no apparent increase in serious infection rate. Trial registration NCT01892345 (ClinicalTrials.gov).

Published
2020

6. Interim Analysis of the STEMTRA Trial: Safety and Dose-Dependent Benefit in Traumatic Brain Injury Patients

Author

Satoshi Ikeda, Neil E. Schwartz, Alan Weintraub, Igor Semeniv, Michael C. Munin, Benjamin M. Frishberg, Albert M. Lai, Yusuke Shinoda, Damien Bates, Steven C. Cramer, and Peter McAllister

Subjects
business.industry, Traumatic brain injury, Anesthesia, Rehabilitation, Dose dependence, Medicine, Physical Therapy, Sports Therapy and Rehabilitation, business, medicine.disease, Interim analysis
Published
2019

7. Twelve-Month Tolerability and Safety of Sumatriptan-Naproxen Sodium for the Treatment of Acute Migraine

Author

Benjamin M. Frishberg, Roger Cady, Shelly E. Lener, Gary E. Ruoff, Ying Zhang, W. James Alexander, Paul Winner, and Shashidhar Kori

Subjects
Adult, Male, Adolescent, Nausea, Migraine Disorders, Analgesic, Treatment Refusal, Naproxen, medicine, Humans, Vasoconstrictor Agents, Adverse effect, Aged, Pregnancy, Dose-Response Relationship, Drug, Sumatriptan, business.industry, Anti-Inflammatory Agents, Non-Steroidal, General Medicine, Middle Aged, medicine.disease, Clinical trial, Drug Combinations, Tolerability, Migraine, Anesthesia, Female, medicine.symptom, business, medicine.drug
Abstract

OBJECTIVES To evaluate the long-term safety and tolerability of sumatriptan-naproxen sodium for the treatment of moderate to severe acute migraines and to assess the safety of administration of an optional second dose. PATIENTS AND METHODS A 12-month, multicenter, open-label safety study was conducted in adults treated for migraine attacks of moderate to severe intensity from April 14, 2004, to August 18, 2005. Safety evaluations included adverse events and laboratory tests. RESULTS Of 600 patients enrolled, 565 (94%) were treated for at least 1 migraine. Of treated patients, 414 (73%) and 362 (64%) completed 6 and 12 months of treatment, respectively. Of the 24,485 attacks treated, 17,144 (70%) were treated with only 1 dose. On average, patients treated 5 migraine attacks per month, with a median of 6 days between attacks. The most common treatment-related adverse events were nausea, muscle tightness, and dizziness. Fourteen patients reported 1 or more serious adverse event with only 1 judged probably related to treatment. No deaths occurred. Eight percent of patients discontinued participation in the study because of adverse events or pregnancy. The rates of adverse events reported were no higher after treatment with 2 tablets (at least 2 hours apart) compared with 1 tablet. CONCLUSIONS In this 12-month data set of more than 24,000 migraine attacks in 565 patients, sumatriptan-naproxen sodium formulated in a single tablet was well tolerated when used episodically for the treatment of acute migraine. The adverse events did not differ from those expected for the individual components alone, and no new or unexpected findings occurred.

Published
2007

8. ASSOCIATION OF INTERNAL CAROTID ARTERY DISSECTION AND CHIROPRACTIC MANIPULATION

Author

Michael T. Haneline, Benjamin M. Frishberg, and Arthur C. Croft

Subjects
medicine.medical_specialty, Internal carotid artery dissection, Neck pain, Manipulation, Chiropractic, business.industry, ICAD, MEDLINE, Carotid Artery, Internal, Dissection, General Medicine, Chiropractic, United States, Risk Factors, Internal medicine, Cervical Vertebrae, Physical therapy, medicine, Humans, Neurology (clinical), Manual therapy, Chiropractic manipulation, medicine.symptom, business, Medical literature
Abstract

Background To determine the relationship between chiropractic manipulative therapy and internal carotid artery dissection, a MEDLINE literature search was performed for the years 1966 through 2000 using the terms internal carotid dissection. Literature that included information concerning causation of ICAD, as well as all case studies and series, was selected for review. Review summary In reviewing the cases of internal carotid dissection potentially related to CMT, there were many confounding factors, such as connective tissue aberrations, underlying arteriopathy, or coexistent infection, that obscured any obvious cause-and-effect relationship. To date there are only 13 reported cases of ICAD temporally related to CMT. Most ICADs seem to occur spontaneously and progress from local symptoms of headache and neck pain to cortical ischemic signs. Approximately one third of the reported cases were manipulated by practitioners other than chiropractic physicians, and because of the differential risk related to major differences in training and practice between practitioners who manipulate the spine, it would be inappropriate to compare adverse outcomes between practitioner groups. Conclusions The medical literature does not support a clear causal relationship between CMT and ICAD. Reported cases are exceedingly scarce, and none support clear cause and effect.

Published
2003

9. Practice parameter for electrodiagnostic studies in carpal tunnel syndrome: Summary statement

Author

Faren H. Williams, George Paulson, Roy G. Ysla, Carl V. Granger, Catherine A. Zahn, Gerard E. Francisco, David J. Thurman, Richard D. Ball, Richard A. Pearl, James Stevens, John C. Cianca, Gary M. Franklin, Yuen T. So, Morris A. Fisher, Cathy A. Sila, Ajay Kumar, David O. Wiechers, Dennis E. Wilkins, William Weiner, Gerard A. Malanga, Stephen Ashwal, Jay H. Rosenberg, Gary H. Friday, Charles K. Jablecki, Lawrence H. Phillips, Myron M. LaBan, Milton Alter, Deborah Hirtz, Michael Glantz, Richard D. Zorowitz, Douglas J. Lanska, Gary S. Gronseth, Michael Cherington, Margaret A. Turk, James S. Lieberman, Richard Dubinsky, Caroline A. Quartly, Mary Kay Floeter, Joel A. DeLisa, Thomas L. Hedge, Rose M. Dotson, Michael J. Vennix, Michael K. Greenberg, Michael T. Andary, R. G. Miller, Mark A. Tomski, Jacqueline A. French, Frank J. Salvi, Deanna M. Janora, Jay M. Meythaler, Benjamin M. Frishberg, John R. Wilson, Jasper R. Daube, John W. Tulloch, and Asa J. Wilbourn

Subjects
medicine.medical_specialty, Physiology, Statement (logic), Neural Conduction, Electromyography, Sensitivity and Specificity, Cellular and Molecular Neuroscience, Physical medicine and rehabilitation, Physiology (medical), Reaction Time, medicine, Humans, Carpal tunnel syndrome, medicine.diagnostic_test, business.industry, Electrodiagnosis, Research, medicine.disease, Carpal Tunnel Syndrome, Median Nerve, Review Literature as Topic, Reference values, Physical therapy, Nerve conduction study, Neurology (clinical), business
Published
2002

10. Coding in neuro-ophthalmology

Author

Benjamin M. Frishberg

Subjects
Male, Tomography Scanners, X-Ray Computed, Computer science, Speech recognition, Tunstall coding, Clinical Coding, Headache, Vision Disorders, Middle Aged, Magnetic Resonance Imaging, Neuro-ophthalmology, Ophthalmology, Young Adult, Neurology, Humans, Female, Neurology (clinical), Modified Huffman coding, Genetics (clinical), Context-adaptive binary arithmetic coding, Coding (social sciences)
Published
2014

11. Neuroimaging in Presumed Primary Headache Disorders

Author

Benjamin M. Frishberg

Subjects
Diagnostic Imaging, Pediatrics, medicine.medical_specialty, Neurology, Migraine Disorders, Cluster Headache, Arteriovenous Malformations, Neuroimaging, medicine, Humans, medicine.diagnostic_test, Brain Neoplasms, business.industry, Cluster headache, Headache, Magnetic resonance imaging, Arteriovenous malformation, medicine.disease, Surgery, Migraine, Chronic Disease, Neurology (clinical), Headaches, medicine.symptom, business, Primary Headache Disorders
Abstract

As routine outpatient neuroimaging became available more than 20 years ago, controversy arose over appropriate selection of patients for computed tomography studies and subsequently magnetic resonance imaging studies. Nowhere is this more apparent than in headache. Because headache is a truly ubiquitous condition with a lifetime prevalence rate reaching 90%, it is clear we cannot scan all patients with headache. Review of the pertinent literature, expert consensus, and a Practice Parameter issued by the American Academy of Neurology all suggest that routine neuroimaging is not necessary in patients with migraine headaches as defined by the International Headache Society criteria. The literature would also support the belief that imaging is not necessary in patients with typical recurrent cluster headaches. However, patients with new-onset headaches, headaches with a progressive course, headaches with a significant change in pattern, headaches that never alternate sides, and headaches associated with any neurologic findings or seizures have a substantially higher likelihood of a secondary cause such as tumor, arteriovenous malformation, or other structural lesion. In these situations, imaging must be considered as part of the workup. Unfortunately, the literature does not provide enough data to make any statistically predictive observations in patients with headaches other than migraine or cluster headache with symptoms but no findings on neurologic examination.

Published
1997

13. MRI and neuropsychological correlates of dementia in Binswanger's disease

Author

Linda R. Sapin, Benjamin M. Frishberg, and John L. Sherman

Subjects
medicine.medical_specialty, Binswanger Disease, medicine.diagnostic_test, Cognitive disorder, Subcortical dementia, Neuropsychology, Magnetic resonance imaging, General Medicine, Binswanger's disease, medicine.disease, Psychiatry and Mental health, Clinical Psychology, Neuropsychology and Physiological Psychology, Physical medicine and rehabilitation, medicine, Disconnection syndrome, Dementia, Psychiatry, Psychology
Abstract

Nuclear magnetic resonance imaging (MRI) has facilitated diagnosis of Binswanger's disease in vivo, which has proven to be a more common disease entity than once believed. These patients generally present with hypertension, progressive dementia, hydrocephalus, gait difficulty, and personality change. A patient is presented with MRI findings of white-matter destruction and subcortical lesions, and with neuropsychological findings of higher-order cognitive impairment but selectively preserved language and visuospatial-perceptual skills. The relationship between the patient's cognitive-behavioral symptoms and the presence of disconnection syndrome is discussed. In addition, the utility of neuropsychological examination is reviewed. Finally, implications for differentiating cortical from subcortical dementia with psychometric test data are discussed.

Published
1990

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