The Experts below are selected from a list of 102 Experts worldwide ranked by ideXlab platform
Kuniaki Iyoda - One of the best experts on this subject based on the ideXlab platform.
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rufinamide as an adjunctive therapy for lennox gastaut syndrome a randomized double blind placebo controlled trial in japan
Epilepsy Research, 2014Co-Authors: Yoko Ohtsuka, Harumi Yoshinaga, Rumiko Takayama, Hiroki Takano, Yukiyoshi Shirasaka, Kuniaki IyodaAbstract:Summary Purpose To evaluate the efficacy, safety, and pharmacokinetics of rufinamide as an adjunctive therapy for patients with Lennox–Gastaut syndrome (LGS) in a randomized, double-blind, placebo-controlled trial. Methods We conducted a multicenter clinical trial with a 4-week baseline, a 2-week titration, a 10-week maintenance, and either a follow-up visit or entry into an open-label extension. Patients with LGS (4 to 30 years old) taking between one and three antiepileptic drugs were recruited. After the baseline period, patients were randomly assigned to rufinamide or placebo. The primary efficacy variable was the percent change in the tonic–Atonic Seizure frequency per 28 days. Key findings Of the 59 patients, 29 were randomized to the rufinamide group and 30 to the placebo group. The frequency of epileptic Seizures was significantly decreased in the rufinamide group than in the placebo group; the median percent change in frequency of tonic–Atonic Seizures was −24.2% and −3.3%, respectively, ( p =0.003) and that of total Seizures was −32.9% and −3.1%, respectively ( p Significance The present results showed a favorable risk-benefit profile for rufinamide as an adjunctive therapy for patients with LGS.
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Rufinamide as an adjunctive therapy for Lennox—Gastaut syndrome: A randomized double-blind placebo-controlled trial in Japan
Epilepsy research, 2014Co-Authors: Yoko Ohtsuka, Harumi Yoshinaga, Rumiko Takayama, Hiroki Takano, Yukiyoshi Shirasaka, Kuniaki IyodaAbstract:Summary Purpose To evaluate the efficacy, safety, and pharmacokinetics of rufinamide as an adjunctive therapy for patients with Lennox–Gastaut syndrome (LGS) in a randomized, double-blind, placebo-controlled trial. Methods We conducted a multicenter clinical trial with a 4-week baseline, a 2-week titration, a 10-week maintenance, and either a follow-up visit or entry into an open-label extension. Patients with LGS (4 to 30 years old) taking between one and three antiepileptic drugs were recruited. After the baseline period, patients were randomly assigned to rufinamide or placebo. The primary efficacy variable was the percent change in the tonic–Atonic Seizure frequency per 28 days. Key findings Of the 59 patients, 29 were randomized to the rufinamide group and 30 to the placebo group. The frequency of epileptic Seizures was significantly decreased in the rufinamide group than in the placebo group; the median percent change in frequency of tonic–Atonic Seizures was −24.2% and −3.3%, respectively, ( p =0.003) and that of total Seizures was −32.9% and −3.1%, respectively ( p Significance The present results showed a favorable risk-benefit profile for rufinamide as an adjunctive therapy for patients with LGS.
Yoko Ohtsuka - One of the best experts on this subject based on the ideXlab platform.
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efficacy and safety of adjunctive rufinamide in lennox gastaut syndrome lgs results from studies 022 022e 303 304 and 305 p1 273
Neurology, 2018Co-Authors: Alexis Arzimanoglou, Yoko Ohtsuka, Carlos Perdomo, Betsy Williams, G Kluger, Francesco Bibbiani, A Muller, Manoj MalhotraAbstract:Objective: Present an overview of efficacy and safety for adjunctive rufinamide in LGS patients aged 1–30 years. Background: LGS, a rare epilepsy syndrome, affects 1–4% of children with epilepsy. Limited treatment options demonstrate inadequate Seizure control and unfavorable tolerability. Design/Methods: Studies 022 (Glauser et al. Neurology 2008;70:1950–1958) and 304 (Ohtsuka et al. Epilepsy Res 2014;108:1627–1636) were Phase III, double-blind, placebo-controlled studies of adjunctive rufinamide in LGS patients aged 4–30 years (28-day Baseline; 84-day Treatment Phase). Rufinamide maintenance dose: 022, ≤45 mg/kg/day; 304, 800–3200 mg/day by body weight (15.0 to ≥70.1 kg). Patients completing 022 or 304 could enter an open-label extension (022E [Kluger et al. Acta Neurol Scand 2010;122:202–208]; 305 [Ohtsuka et al. Epilepsy Res 2016;121:1–7], respectively). The Phase III, randomized, open-label Study 303 (Arzimanoglou et al. EJPN 2016;20:393–402) assessed adjunctive rufinamide (45 mg/kg/day) versus any-other-AED (antiepileptic drug) in patients aged 1– Results: Median percent reduction in tonic-Atonic Seizure frequency: 022, 42.5% rufinamide (n=74) and −1.4% placebo (n=64; P P =0.003). Median percent reduction in total Seizure frequency: 022, 32.7% rufinamide and 11.7% placebo ( P =0.0015); 304, 32.9% and 3.1%, respectively ( P Conclusions: There were significant reductions in Seizure frequencies for adjunctive rufinamide versus placebo in LGS patients aged 4–30 years. Safety of adjunctive rufinamide was confirmed in LGS patients aged 1– Study Supported by: Eisai Inc. Disclosure: Dr. Arzimanoglou has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Eisai, UCB, GW, Zogenix, Takeda, Shire, Upsher-Smith. Dr. Arzimanoglou has received research support from Eisai, Caixa Bank Spain, UCB. Dr. Kluger has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Gerhard Kluger has served on advisory boards and received speaking honoraria from UCB Inc. and Eisai Inc. Dr. Kluger has received research support from Eisai Inc. Dr. Muller has nothing to disclose. Dr. Ohtsuka has nothing to disclose. Dr. Williams has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Eisai Inc. Dr. Williams holds stock and/or stock options in Spouse is employee of Stryker Orthopedics. Dr. Williams has received research support from Employee of Eisai Inc. Dr. Bibbiani has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Eisai employee. Dr. Perdomo has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Eisai Inc. Dr. Malhotra has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Eisai Inc.
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rufinamide as an adjunctive therapy for lennox gastaut syndrome a randomized double blind placebo controlled trial in japan
Epilepsy Research, 2014Co-Authors: Yoko Ohtsuka, Harumi Yoshinaga, Rumiko Takayama, Hiroki Takano, Yukiyoshi Shirasaka, Kuniaki IyodaAbstract:Summary Purpose To evaluate the efficacy, safety, and pharmacokinetics of rufinamide as an adjunctive therapy for patients with Lennox–Gastaut syndrome (LGS) in a randomized, double-blind, placebo-controlled trial. Methods We conducted a multicenter clinical trial with a 4-week baseline, a 2-week titration, a 10-week maintenance, and either a follow-up visit or entry into an open-label extension. Patients with LGS (4 to 30 years old) taking between one and three antiepileptic drugs were recruited. After the baseline period, patients were randomly assigned to rufinamide or placebo. The primary efficacy variable was the percent change in the tonic–Atonic Seizure frequency per 28 days. Key findings Of the 59 patients, 29 were randomized to the rufinamide group and 30 to the placebo group. The frequency of epileptic Seizures was significantly decreased in the rufinamide group than in the placebo group; the median percent change in frequency of tonic–Atonic Seizures was −24.2% and −3.3%, respectively, ( p =0.003) and that of total Seizures was −32.9% and −3.1%, respectively ( p Significance The present results showed a favorable risk-benefit profile for rufinamide as an adjunctive therapy for patients with LGS.
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Rufinamide as an adjunctive therapy for Lennox—Gastaut syndrome: A randomized double-blind placebo-controlled trial in Japan
Epilepsy research, 2014Co-Authors: Yoko Ohtsuka, Harumi Yoshinaga, Rumiko Takayama, Hiroki Takano, Yukiyoshi Shirasaka, Kuniaki IyodaAbstract:Summary Purpose To evaluate the efficacy, safety, and pharmacokinetics of rufinamide as an adjunctive therapy for patients with Lennox–Gastaut syndrome (LGS) in a randomized, double-blind, placebo-controlled trial. Methods We conducted a multicenter clinical trial with a 4-week baseline, a 2-week titration, a 10-week maintenance, and either a follow-up visit or entry into an open-label extension. Patients with LGS (4 to 30 years old) taking between one and three antiepileptic drugs were recruited. After the baseline period, patients were randomly assigned to rufinamide or placebo. The primary efficacy variable was the percent change in the tonic–Atonic Seizure frequency per 28 days. Key findings Of the 59 patients, 29 were randomized to the rufinamide group and 30 to the placebo group. The frequency of epileptic Seizures was significantly decreased in the rufinamide group than in the placebo group; the median percent change in frequency of tonic–Atonic Seizures was −24.2% and −3.3%, respectively, ( p =0.003) and that of total Seizures was −32.9% and −3.1%, respectively ( p Significance The present results showed a favorable risk-benefit profile for rufinamide as an adjunctive therapy for patients with LGS.
S Arroyo - One of the best experts on this subject based on the ideXlab platform.
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adjunctive rufinamide in lennox gastaut syndrome a long term open label extension study
Acta Neurologica Scandinavica, 2010Co-Authors: Gerhard Kluger, Tracy A Glauser, Gregory Krauss, R Seeruthun, Carlos Perdomo, S ArroyoAbstract:Kluger G, Glauser T, Krauss G, Seeruthun R, Perdomo C, Arroyo S. Adjunctive rufinamide in Lennox-Gastaut syndrome: a long-term, open-label extension study. Acta Neurol Scand: 122: 202–208. © 2010 The Authors Journal compilation © 2010 Blackwell Munksgaard. Objective – This open-label extension evaluated the long-term efficacy and tolerability of rufinamide in patients with Lennox-Gastaut syndrome (LGS) who had previously completed a 12-week double-blind study. Materials and methods – In total, 124 patients (aged 4–37 years), receiving 1–3 concomitant antiepileptic drugs, were treated with rufinamide ∼25–60 mg/kg/day. Efficacy was assessed by Seizure frequency; tolerability by adverse events (AEs) and laboratory tests. Results – Overall, patients were treated with rufinamide for a median (range) of 432 (10–1149) days. Reductions in Seizure frequency were observed throughout the study; during the last 12 months of treatment, 41.0% and 47.9% of patients had ≥50% reduction in total and tonic–Atonic Seizure frequency, respectively. The most common AEs were vomiting (30.6%) and pyrexia (25.8%). Conclusions – In this open-label extension, rufinamide appeared to be an effective long-term adjunctive therapy for the treatment of LGS-associated Seizures in children and young adults.
Nobuo Hashimoto - One of the best experts on this subject based on the ideXlab platform.
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Partial Epilepsy Manifesting Atonic Seizure: Report of Two Cases
Epilepsia, 2002Co-Authors: Takeshi Satow, Akio Ikeda, Junichi Yamamoto, Motohiro Takayama, Masao Matsuhashi, Shinji Ohara, Riki Matsumoto, Tahamina Begum, Hidenao Fukuyama, Nobuo HashimotoAbstract:Summary: Purpose: Atonic Seizures are commonly seen in patients with generalized epilepsy but only infrequently in patients with partial epilepsy. Clinically generalized Atonic Seizures as a partial epilepsy have not been studied in detail with video/EEG monitoring. Here we describe the clinical and physiologic characteristics of Atonic Seizures due to partial epilepsy and discuss the underlying mechanism. Methods: Two patients with partial epilepsy manifesting Atonic Seizures, one with frontal lobe epilepsy (FLE) and the other with parietal lobe epilepsy (PLE), were reported. The long-term video/EEG monitoring, magnetic resonance imaging (MRI), and interictal fluorodeoxyglucose–positron emission tomography (FDG-PET) were investigated in each patient. Results: Paroxysmal diminution of muscle tone mainly involved the axial muscles in both patients. In contrast with the abrupt falls seen in patients with Lennox–Gastaut syndrome, the falls in these patients were slow, taking 2–5 s to fall down. Ictal EEG records showed low-voltage fast activity in the frontocentral area followed by repetitive spikes at the midline frontocentral area in the patient with FLE, and rhythmic spikes in the left central area in the patient with PLE. Interictal FDG-PET disclosed hypometabolic regions consistent with the clinical and EEG findings. Conclusions: Slow falls might be a feature of Atonic Seizures in partial epilepsy. Long-lasting atonia in partial epilepsy could be due to either one of the following two possible mechanisms: (a) epileptic activities arising from the negative motor area, of which 50-Hz electric stimulation causes motor inhibition, or (b) sustained atonia with successive electromyogram (EMG) silent periods caused by epileptic discharges arising from the inhibitory area of the primary sensorimotor area.
Carlos Perdomo - One of the best experts on this subject based on the ideXlab platform.
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efficacy and safety of adjunctive rufinamide in lennox gastaut syndrome lgs results from studies 022 022e 303 304 and 305 p1 273
Neurology, 2018Co-Authors: Alexis Arzimanoglou, Yoko Ohtsuka, Carlos Perdomo, Betsy Williams, G Kluger, Francesco Bibbiani, A Muller, Manoj MalhotraAbstract:Objective: Present an overview of efficacy and safety for adjunctive rufinamide in LGS patients aged 1–30 years. Background: LGS, a rare epilepsy syndrome, affects 1–4% of children with epilepsy. Limited treatment options demonstrate inadequate Seizure control and unfavorable tolerability. Design/Methods: Studies 022 (Glauser et al. Neurology 2008;70:1950–1958) and 304 (Ohtsuka et al. Epilepsy Res 2014;108:1627–1636) were Phase III, double-blind, placebo-controlled studies of adjunctive rufinamide in LGS patients aged 4–30 years (28-day Baseline; 84-day Treatment Phase). Rufinamide maintenance dose: 022, ≤45 mg/kg/day; 304, 800–3200 mg/day by body weight (15.0 to ≥70.1 kg). Patients completing 022 or 304 could enter an open-label extension (022E [Kluger et al. Acta Neurol Scand 2010;122:202–208]; 305 [Ohtsuka et al. Epilepsy Res 2016;121:1–7], respectively). The Phase III, randomized, open-label Study 303 (Arzimanoglou et al. EJPN 2016;20:393–402) assessed adjunctive rufinamide (45 mg/kg/day) versus any-other-AED (antiepileptic drug) in patients aged 1– Results: Median percent reduction in tonic-Atonic Seizure frequency: 022, 42.5% rufinamide (n=74) and −1.4% placebo (n=64; P P =0.003). Median percent reduction in total Seizure frequency: 022, 32.7% rufinamide and 11.7% placebo ( P =0.0015); 304, 32.9% and 3.1%, respectively ( P Conclusions: There were significant reductions in Seizure frequencies for adjunctive rufinamide versus placebo in LGS patients aged 4–30 years. Safety of adjunctive rufinamide was confirmed in LGS patients aged 1– Study Supported by: Eisai Inc. Disclosure: Dr. Arzimanoglou has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Eisai, UCB, GW, Zogenix, Takeda, Shire, Upsher-Smith. Dr. Arzimanoglou has received research support from Eisai, Caixa Bank Spain, UCB. Dr. Kluger has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Gerhard Kluger has served on advisory boards and received speaking honoraria from UCB Inc. and Eisai Inc. Dr. Kluger has received research support from Eisai Inc. Dr. Muller has nothing to disclose. Dr. Ohtsuka has nothing to disclose. Dr. Williams has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Eisai Inc. Dr. Williams holds stock and/or stock options in Spouse is employee of Stryker Orthopedics. Dr. Williams has received research support from Employee of Eisai Inc. Dr. Bibbiani has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Eisai employee. Dr. Perdomo has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Eisai Inc. Dr. Malhotra has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Eisai Inc.
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adjunctive rufinamide in lennox gastaut syndrome a long term open label extension study
Acta Neurologica Scandinavica, 2010Co-Authors: Gerhard Kluger, Tracy A Glauser, Gregory Krauss, R Seeruthun, Carlos Perdomo, S ArroyoAbstract:Kluger G, Glauser T, Krauss G, Seeruthun R, Perdomo C, Arroyo S. Adjunctive rufinamide in Lennox-Gastaut syndrome: a long-term, open-label extension study. Acta Neurol Scand: 122: 202–208. © 2010 The Authors Journal compilation © 2010 Blackwell Munksgaard. Objective – This open-label extension evaluated the long-term efficacy and tolerability of rufinamide in patients with Lennox-Gastaut syndrome (LGS) who had previously completed a 12-week double-blind study. Materials and methods – In total, 124 patients (aged 4–37 years), receiving 1–3 concomitant antiepileptic drugs, were treated with rufinamide ∼25–60 mg/kg/day. Efficacy was assessed by Seizure frequency; tolerability by adverse events (AEs) and laboratory tests. Results – Overall, patients were treated with rufinamide for a median (range) of 432 (10–1149) days. Reductions in Seizure frequency were observed throughout the study; during the last 12 months of treatment, 41.0% and 47.9% of patients had ≥50% reduction in total and tonic–Atonic Seizure frequency, respectively. The most common AEs were vomiting (30.6%) and pyrexia (25.8%). Conclusions – In this open-label extension, rufinamide appeared to be an effective long-term adjunctive therapy for the treatment of LGS-associated Seizures in children and young adults.