Long-term safety and efficacy of clobazam for Lennox-Gastaut syndrome: interim results of an open-label extension study
Yu-Tze Ng, Joan Conry, Juliann Paolicchi, Lydia Kernitsky, Wendy Mitchell, Rebecca Drummond, Jouko Isojarvi, Deborah Lee, Randall Owen, OV-1004 study investigators, Terence O'Brien, Ingrid Scheffer, Halina Navumava, Arijit Chattopadhyay, Anand Prakash Dubey, Anaita Hegde, Lekha Pandit, Surekha Rajadhyaksha, Gosala R Sarma, Shankar Nellikunja, Maneesh Kumar Singh, Vrajesh Udani, Devananthan Vasudevan, Nandan Yardi, Nerija Vaiciene, Susan T Arnold, Blaise Bourgeois, Martina Bebin, Meriem Bensalem-Owen, Jeffrey Buchhalter, Tsao Chang-Yong, Steve S Chung, Joan A Conry, Roy Elterman, Jose Ferreira, Matthew Frank, Angel Hernandez, Gregory L Holmes, Andres M Kanner, Lydia Kernitsky, Pavel Klein, Paul M Levisohn, Edwin Liu, Eric Marsh, Mark Mintz, Wendy Mitchell, Yu-Tze Ng, Dipakumar Pandya, Juliann Paolicchi, Yong D Park, J Ben Renfroe, Anthony R Riela, Rosario Maria Riel-Romero, Frank J Ritter, William Rosenfeld, Michael Schwabe, Michael R Sperling, Elizabeth A Thiele, David Wang, Robert Wechsler, James W Wheless, Angus Wilfong, Brenda Y Wu, Yu-Tze Ng, Joan Conry, Juliann Paolicchi, Lydia Kernitsky, Wendy Mitchell, Rebecca Drummond, Jouko Isojarvi, Deborah Lee, Randall Owen, OV-1004 study investigators, Terence O'Brien, Ingrid Scheffer, Halina Navumava, Arijit Chattopadhyay, Anand Prakash Dubey, Anaita Hegde, Lekha Pandit, Surekha Rajadhyaksha, Gosala R Sarma, Shankar Nellikunja, Maneesh Kumar Singh, Vrajesh Udani, Devananthan Vasudevan, Nandan Yardi, Nerija Vaiciene, Susan T Arnold, Blaise Bourgeois, Martina Bebin, Meriem Bensalem-Owen, Jeffrey Buchhalter, Tsao Chang-Yong, Steve S Chung, Joan A Conry, Roy Elterman, Jose Ferreira, Matthew Frank, Angel Hernandez, Gregory L Holmes, Andres M Kanner, Lydia Kernitsky, Pavel Klein, Paul M Levisohn, Edwin Liu, Eric Marsh, Mark Mintz, Wendy Mitchell, Yu-Tze Ng, Dipakumar Pandya, Juliann Paolicchi, Yong D Park, J Ben Renfroe, Anthony R Riela, Rosario Maria Riel-Romero, Frank J Ritter, William Rosenfeld, Michael Schwabe, Michael R Sperling, Elizabeth A Thiele, David Wang, Robert Wechsler, James W Wheless, Angus Wilfong, Brenda Y Wu
Abstract
In an ongoing open-label extension (OV-1004), patients with Lennox-Gastaut syndrome who had completed 1 of 2 randomized controlled trials (OV-1002 [Phase II] or OV-1012 [Phase III]) are receiving clobazam at dosages ≤2.0 mg/kg/day (≤80 mg/day). Of 306 eligible patients from OV-1002 or OV-1012, 267 entered the open-label extension. As of the interim date, July 1, 2010, 213 patients (79.8%) had remained in the trial, and 189 had received clobazam for ≥12 months, 128 for ≥18 months, and 94 for ≥24 months. Median percentage decreases in average weekly rates of drop seizures were 71.1% and 91.6% at Months 3 and 24. Mean modal and mean maximum daily dosages were 0.94 mg/kg and 1.22 mg/kg for those who had received clobazam for ≥1 year. The 4 most common adverse events were upper respiratory tract infection (18.4%), fall (14.2%), pneumonia (13.9%), and somnolence (12.7%). Clobazam's adverse event profile was consistent with its profile in controlled trials.
Copyright © 2012 Elsevier Inc. All rights reserved.
Source: PubMed