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Tracy A Glauser - One of the best experts on this subject based on the ideXlab platform.

  • adjunctive rufinamide in Lennox Gastaut Syndrome a long term open label extension study
    Acta Neurologica Scandinavica, 2010
    Co-Authors: G Kluger, Tracy A Glauser, Carlos Perdomo, Gregory Krauss, R Seeruthun, S Arroyo
    Abstract:

    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.

  • rufinamide for generalized seizures associated with Lennox Gastaut Syndrome
    Neurology, 2008
    Co-Authors: Tracy A Glauser, G Kluger, R Sachdeo, Gregory L Krauss, Carlos Perdomo, S Arroyo
    Abstract:

    Background: LennoxGastaut Syndrome is a catastrophic pediatric epilepsy Syndrome characterized by multiple types of treatment-resistant seizures and high rates of seizure-related injury. Current available treatments are inadequate, leaving patients with few treatment options and opportunities. Methods: We conducted a double-blind, randomized, placebo-controlled trial of the antiepileptic drug rufinamide in patients with LennoxGastaut Syndrome. Eligible patients between 4 and 30 years of age had multiple types of seizures (including tonic–atonic and atypical absence seizures) with a minimum of 90 seizures in the month before baseline and a recent history of a slow spike-and-wave pattern on EEG. Results: After a 28-day baseline period, 139 eligible patients were randomized; 138 patients received either rufinamide (n = 74) or placebo (n = 64) in addition to their other antiepileptic drugs. The median percentage reduction in total seizure frequency was greater in the rufinamide therapy group than in the placebo group (32.7% vs 11.7%, p = 0.0015). There was a difference ( p p = 0.0041) and a higher 50% responder rate compared with placebo for total seizures ( p = 0.0045) and tonic–atonic seizures ( p = 0.002). The common adverse events (reported by ≥10% of patients receiving rufinamide) were somnolence (24.3% with rufinamide vs 12.5% with placebo) and vomiting (21.6% vs 6.3%). Conclusions: Rufinamide was an effective and well-tolerated treatment for seizures associated with LennoxGastaut Syndrome.

  • Rufinamide for generalized seizures associated with LennoxGastaut Syndrome
    Neurology, 2008
    Co-Authors: Tracy A Glauser, R Sachdeo, Gregory L Krauss, Carlos Perdomo, Gerhard Kluger, S Arroyo
    Abstract:

    Background: LennoxGastaut Syndrome is a catastrophic pediatric epilepsy Syndrome characterized by multiple types of treatment-resistant seizures and high rates of seizure-related injury. Current available treatments are inadequate, leaving patients with few treatment options and opportunities. Methods: We conducted a double-blind, randomized, placebo-controlled trial of the antiepileptic drug rufinamide in patients with LennoxGastaut Syndrome. Eligible patients between 4 and 30 years of age had multiple types of seizures (including tonic–atonic and atypical absence seizures) with a minimum of 90 seizures in the month before baseline and a recent history of a slow spike-and-wave pattern on EEG. Results: After a 28-day baseline period, 139 eligible patients were randomized; 138 patients received either rufinamide (n = 74) or placebo (n = 64) in addition to their other antiepileptic drugs. The median percentage reduction in total seizure frequency was greater in the rufinamide therapy group than in the placebo group (32.7% vs 11.7%, p = 0.0015). There was a difference ( p p = 0.0041) and a higher 50% responder rate compared with placebo for total seizures ( p = 0.0045) and tonic–atonic seizures ( p = 0.002). The common adverse events (reported by ≥10% of patients receiving rufinamide) were somnolence (24.3% with rufinamide vs 12.5% with placebo) and vomiting (21.6% vs 6.3%). Conclusions: Rufinamide was an effective and well-tolerated treatment for seizures associated with LennoxGastaut Syndrome.

  • A double-blind, randomized trial of topiramate in LennoxGastaut Syndrome
    Neurology, 1999
    Co-Authors: R Sachdeo, Tracy A Glauser, Frank J Ritter, R Reife, G Pledger
    Abstract:

    Objective: To evaluate the efficacy and safety of topiramate as adjunctive therapy for LennoxGastaut Syndrome in a multicenter, double-blind, placebo-controlled trial. Background: Conventional antiepileptic drugs are frequently ineffective against multiple-seizure types of LennoxGastaut Syndrome. Methods: Ninety-eight patients >1 year to Results: For drop attacks, the most severe seizures associated with this Syndrome, the median percentage reduction from baseline in average monthly seizure rate was 14.8% for the topiramate group and −5.1% (an increase) for the placebo group ( p = 0.041). Topiramate-treated patients demonstrated greater improvement in seizure severity than did placebo-treated patients based on parental global evaluations ( p = 0.037). The percentage of patients with a ≥50% reduction from baseline in major seizures (drop attacks and tonic-clonic seizures) was greater in the topiramate group (15/46 or 33%) than in the control group (4/50 or 8%; p = 0.002). The most common adverse events in both groups were CNS related; there were no discontinuations from topiramate therapy due to adverse events. Conclusions: Topiramate adjunctive therapy was effective in reducing the number of drop attacks and major motor seizures and in improving seizure severity as determined by parental global evaluation.

  • a double blind randomized trial of topiramate in Lennox Gastaut Syndrome
    Neurology, 1999
    Co-Authors: R Sachdeo, Tracy A Glauser, Frank J Ritter, R Reife, G Pledger
    Abstract:

    Objective: To evaluate the efficacy and safety of topiramate as adjunctive therapy for LennoxGastaut Syndrome in a multicenter, double-blind, placebo-controlled trial. Background: Conventional antiepileptic drugs are frequently ineffective against multiple-seizure types of LennoxGastaut Syndrome. Methods: Ninety-eight patients >1 year to Results: For drop attacks, the most severe seizures associated with this Syndrome, the median percentage reduction from baseline in average monthly seizure rate was 14.8% for the topiramate group and −5.1% (an increase) for the placebo group ( p = 0.041). Topiramate-treated patients demonstrated greater improvement in seizure severity than did placebo-treated patients based on parental global evaluations ( p = 0.037). The percentage of patients with a ≥50% reduction from baseline in major seizures (drop attacks and tonic-clonic seizures) was greater in the topiramate group (15/46 or 33%) than in the control group (4/50 or 8%; p = 0.002). The most common adverse events in both groups were CNS related; there were no discontinuations from topiramate therapy due to adverse events. Conclusions: Topiramate adjunctive therapy was effective in reducing the number of drop attacks and major motor seizures and in improving seizure severity as determined by parental global evaluation.

S Arroyo - One of the best experts on this subject based on the ideXlab platform.

  • adjunctive rufinamide in Lennox Gastaut Syndrome a long term open label extension study
    Acta Neurologica Scandinavica, 2010
    Co-Authors: G Kluger, Tracy A Glauser, Carlos Perdomo, Gregory Krauss, R Seeruthun, S Arroyo
    Abstract:

    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.

  • rufinamide for generalized seizures associated with Lennox Gastaut Syndrome
    Neurology, 2008
    Co-Authors: Tracy A Glauser, G Kluger, R Sachdeo, Gregory L Krauss, Carlos Perdomo, S Arroyo
    Abstract:

    Background: LennoxGastaut Syndrome is a catastrophic pediatric epilepsy Syndrome characterized by multiple types of treatment-resistant seizures and high rates of seizure-related injury. Current available treatments are inadequate, leaving patients with few treatment options and opportunities. Methods: We conducted a double-blind, randomized, placebo-controlled trial of the antiepileptic drug rufinamide in patients with LennoxGastaut Syndrome. Eligible patients between 4 and 30 years of age had multiple types of seizures (including tonic–atonic and atypical absence seizures) with a minimum of 90 seizures in the month before baseline and a recent history of a slow spike-and-wave pattern on EEG. Results: After a 28-day baseline period, 139 eligible patients were randomized; 138 patients received either rufinamide (n = 74) or placebo (n = 64) in addition to their other antiepileptic drugs. The median percentage reduction in total seizure frequency was greater in the rufinamide therapy group than in the placebo group (32.7% vs 11.7%, p = 0.0015). There was a difference ( p p = 0.0041) and a higher 50% responder rate compared with placebo for total seizures ( p = 0.0045) and tonic–atonic seizures ( p = 0.002). The common adverse events (reported by ≥10% of patients receiving rufinamide) were somnolence (24.3% with rufinamide vs 12.5% with placebo) and vomiting (21.6% vs 6.3%). Conclusions: Rufinamide was an effective and well-tolerated treatment for seizures associated with LennoxGastaut Syndrome.

  • Rufinamide for generalized seizures associated with LennoxGastaut Syndrome
    Neurology, 2008
    Co-Authors: Tracy A Glauser, R Sachdeo, Gregory L Krauss, Carlos Perdomo, Gerhard Kluger, S Arroyo
    Abstract:

    Background: LennoxGastaut Syndrome is a catastrophic pediatric epilepsy Syndrome characterized by multiple types of treatment-resistant seizures and high rates of seizure-related injury. Current available treatments are inadequate, leaving patients with few treatment options and opportunities. Methods: We conducted a double-blind, randomized, placebo-controlled trial of the antiepileptic drug rufinamide in patients with LennoxGastaut Syndrome. Eligible patients between 4 and 30 years of age had multiple types of seizures (including tonic–atonic and atypical absence seizures) with a minimum of 90 seizures in the month before baseline and a recent history of a slow spike-and-wave pattern on EEG. Results: After a 28-day baseline period, 139 eligible patients were randomized; 138 patients received either rufinamide (n = 74) or placebo (n = 64) in addition to their other antiepileptic drugs. The median percentage reduction in total seizure frequency was greater in the rufinamide therapy group than in the placebo group (32.7% vs 11.7%, p = 0.0015). There was a difference ( p p = 0.0041) and a higher 50% responder rate compared with placebo for total seizures ( p = 0.0045) and tonic–atonic seizures ( p = 0.002). The common adverse events (reported by ≥10% of patients receiving rufinamide) were somnolence (24.3% with rufinamide vs 12.5% with placebo) and vomiting (21.6% vs 6.3%). Conclusions: Rufinamide was an effective and well-tolerated treatment for seizures associated with LennoxGastaut Syndrome.

Kevin Farrell - One of the best experts on this subject based on the ideXlab platform.

  • Drug Therapy in Lennox-Gastaut Syndrome
    Advances in Experimental Medicine and Biology, 2020
    Co-Authors: Kevin Farrell
    Abstract:

    A logical approach to the pharmacological management of Lennox-Gastaut Syndrome (LGS) is complicated by several factors. There have been few well-designed studies of antiepileptic drugs in LGS. In addition, the criteria used for the diagnosis of LGS vary between studies. The multitude of different approaches to drug treatment reflects the evidence-based vacuum in which the treatment of LGS exists. This chapter will discuss some of these issues and will describe the authors approach to drug treatment of this condition.

  • Medical management of Lennox-Gastaut Syndrome
    CNS Drugs, 2010
    Co-Authors: Aspasia Michoulas, Kevin Farrell
    Abstract:

    Lennox-Gastaut Syndrome occurs in 3% of children with epilepsy and is characterized by multiple seizure types, slow spike-and-wave discharges and a poor prognosis for seizure control and cognitive development. Although randomized controlled trials of adjunctive felbamate, lamotrigine, topiramate and rufinamide have demonstrated a ≥50% reduction in seizure frequency, very few children achieve complete seizure control and a Cochrane review of the treatment of Lennox-Gastaut Syndrome concluded that the optimum treatment was uncertain and that no drug has been shown to be highly efficacious. Valproate, lamotrigine and topiramate were considered recently by expert panels in the US and Europe to be the first-line drugs. The ketogenic diet may be more effective than antiepileptic drugs and should be considered early in treatment. An improvement in the management of Lennox-Gastaut Syndrome requires a better understanding of the pathophysiology of this disorder and the development of animal models in which to test new compounds.

  • medical management of Lennox Gastaut Syndrome
    CNS Drugs, 2010
    Co-Authors: Aspasia Michoulas, Kevin Farrell
    Abstract:

    Lennox-Gastaut Syndrome occurs in 3% of children with epilepsy and is characterized by multiple seizure types, slow spike-and-wave discharges and a poor prognosis for seizure control and cognitive development. Although randomized controlled trials of adjunctive felbamate, lamotrigine, topiramate and rufinamide have demonstrated a ≥50% reduction in seizure frequency, very few children achieve complete seizure control and a Cochrane review of the treatment of Lennox-Gastaut Syndrome concluded that the optimum treatment was uncertain and that no drug has been shown to be highly efficacious. Valproate, lamotrigine and topiramate were considered recently by expert panels in the US and Europe to be the first-line drugs. The ketogenic diet may be more effective than antiepileptic drugs and should be considered early in treatment.

R Sachdeo - One of the best experts on this subject based on the ideXlab platform.

  • rufinamide for generalized seizures associated with Lennox Gastaut Syndrome
    Neurology, 2008
    Co-Authors: Tracy A Glauser, G Kluger, R Sachdeo, Gregory L Krauss, Carlos Perdomo, S Arroyo
    Abstract:

    Background: LennoxGastaut Syndrome is a catastrophic pediatric epilepsy Syndrome characterized by multiple types of treatment-resistant seizures and high rates of seizure-related injury. Current available treatments are inadequate, leaving patients with few treatment options and opportunities. Methods: We conducted a double-blind, randomized, placebo-controlled trial of the antiepileptic drug rufinamide in patients with LennoxGastaut Syndrome. Eligible patients between 4 and 30 years of age had multiple types of seizures (including tonic–atonic and atypical absence seizures) with a minimum of 90 seizures in the month before baseline and a recent history of a slow spike-and-wave pattern on EEG. Results: After a 28-day baseline period, 139 eligible patients were randomized; 138 patients received either rufinamide (n = 74) or placebo (n = 64) in addition to their other antiepileptic drugs. The median percentage reduction in total seizure frequency was greater in the rufinamide therapy group than in the placebo group (32.7% vs 11.7%, p = 0.0015). There was a difference ( p p = 0.0041) and a higher 50% responder rate compared with placebo for total seizures ( p = 0.0045) and tonic–atonic seizures ( p = 0.002). The common adverse events (reported by ≥10% of patients receiving rufinamide) were somnolence (24.3% with rufinamide vs 12.5% with placebo) and vomiting (21.6% vs 6.3%). Conclusions: Rufinamide was an effective and well-tolerated treatment for seizures associated with LennoxGastaut Syndrome.

  • Rufinamide for generalized seizures associated with LennoxGastaut Syndrome
    Neurology, 2008
    Co-Authors: Tracy A Glauser, R Sachdeo, Gregory L Krauss, Carlos Perdomo, Gerhard Kluger, S Arroyo
    Abstract:

    Background: LennoxGastaut Syndrome is a catastrophic pediatric epilepsy Syndrome characterized by multiple types of treatment-resistant seizures and high rates of seizure-related injury. Current available treatments are inadequate, leaving patients with few treatment options and opportunities. Methods: We conducted a double-blind, randomized, placebo-controlled trial of the antiepileptic drug rufinamide in patients with LennoxGastaut Syndrome. Eligible patients between 4 and 30 years of age had multiple types of seizures (including tonic–atonic and atypical absence seizures) with a minimum of 90 seizures in the month before baseline and a recent history of a slow spike-and-wave pattern on EEG. Results: After a 28-day baseline period, 139 eligible patients were randomized; 138 patients received either rufinamide (n = 74) or placebo (n = 64) in addition to their other antiepileptic drugs. The median percentage reduction in total seizure frequency was greater in the rufinamide therapy group than in the placebo group (32.7% vs 11.7%, p = 0.0015). There was a difference ( p p = 0.0041) and a higher 50% responder rate compared with placebo for total seizures ( p = 0.0045) and tonic–atonic seizures ( p = 0.002). The common adverse events (reported by ≥10% of patients receiving rufinamide) were somnolence (24.3% with rufinamide vs 12.5% with placebo) and vomiting (21.6% vs 6.3%). Conclusions: Rufinamide was an effective and well-tolerated treatment for seizures associated with LennoxGastaut Syndrome.

  • A double-blind, randomized trial of topiramate in LennoxGastaut Syndrome
    Neurology, 1999
    Co-Authors: R Sachdeo, Tracy A Glauser, Frank J Ritter, R Reife, G Pledger
    Abstract:

    Objective: To evaluate the efficacy and safety of topiramate as adjunctive therapy for LennoxGastaut Syndrome in a multicenter, double-blind, placebo-controlled trial. Background: Conventional antiepileptic drugs are frequently ineffective against multiple-seizure types of LennoxGastaut Syndrome. Methods: Ninety-eight patients >1 year to Results: For drop attacks, the most severe seizures associated with this Syndrome, the median percentage reduction from baseline in average monthly seizure rate was 14.8% for the topiramate group and −5.1% (an increase) for the placebo group ( p = 0.041). Topiramate-treated patients demonstrated greater improvement in seizure severity than did placebo-treated patients based on parental global evaluations ( p = 0.037). The percentage of patients with a ≥50% reduction from baseline in major seizures (drop attacks and tonic-clonic seizures) was greater in the topiramate group (15/46 or 33%) than in the control group (4/50 or 8%; p = 0.002). The most common adverse events in both groups were CNS related; there were no discontinuations from topiramate therapy due to adverse events. Conclusions: Topiramate adjunctive therapy was effective in reducing the number of drop attacks and major motor seizures and in improving seizure severity as determined by parental global evaluation.

  • a double blind randomized trial of topiramate in Lennox Gastaut Syndrome
    Neurology, 1999
    Co-Authors: R Sachdeo, Tracy A Glauser, Frank J Ritter, R Reife, G Pledger
    Abstract:

    Objective: To evaluate the efficacy and safety of topiramate as adjunctive therapy for LennoxGastaut Syndrome in a multicenter, double-blind, placebo-controlled trial. Background: Conventional antiepileptic drugs are frequently ineffective against multiple-seizure types of LennoxGastaut Syndrome. Methods: Ninety-eight patients >1 year to Results: For drop attacks, the most severe seizures associated with this Syndrome, the median percentage reduction from baseline in average monthly seizure rate was 14.8% for the topiramate group and −5.1% (an increase) for the placebo group ( p = 0.041). Topiramate-treated patients demonstrated greater improvement in seizure severity than did placebo-treated patients based on parental global evaluations ( p = 0.037). The percentage of patients with a ≥50% reduction from baseline in major seizures (drop attacks and tonic-clonic seizures) was greater in the topiramate group (15/46 or 33%) than in the control group (4/50 or 8%; p = 0.002). The most common adverse events in both groups were CNS related; there were no discontinuations from topiramate therapy due to adverse events. Conclusions: Topiramate adjunctive therapy was effective in reducing the number of drop attacks and major motor seizures and in improving seizure severity as determined by parental global evaluation.

G Kluger - One of the best experts on this subject based on the ideXlab platform.

  • adjunctive rufinamide in Lennox Gastaut Syndrome a long term open label extension study
    Acta Neurologica Scandinavica, 2010
    Co-Authors: G Kluger, Tracy A Glauser, Carlos Perdomo, Gregory Krauss, R Seeruthun, S Arroyo
    Abstract:

    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.

  • Lennox Gastaut Syndrome a consensus approach on diagnosis assessment management and trial methodology
    Lancet Neurology, 2009
    Co-Authors: Alexis Arzimanoglou, Warren T. Blume, Pierre Genton, Renzo Guerrini, Jacqueline A French, Helen J Cross, Jan Peter Ernst, Martha Feucht, G Kluger, John M Pellock
    Abstract:

    Summary Lennox-Gastaut Syndrome is one of the most severe epileptic encephalopathies of childhood onset. The cause of this Syndrome can be symptomatic (ie, secondary to an underlying brain disorder) or cryptogenic (ie, has no known cause). Although Lennox-Gastaut Syndrome is commonly characterised by a triad of signs, which include multiple seizure types, slow spike-wave complexes on electroencephalographic (EEG) recordings, and impairment of cognitive function, there is debate with regard to the precise limits, cause, and diagnosis of the Syndrome. Tonic seizures, which are thought to be a characteristic sign of Lennox-Gastaut Syndrome, are not present at onset and the EEG features are not pathognomonic of the disorder. There are few effective treatment options for the multiple seizures and comorbidities, and the long-term outlook is poor for most patients. Probably as a result of the complexity of the disorder, only a few randomised trials have studied Lennox-Gastaut Syndrome, and thus many of the drugs that are more commonly used have little or no supporting evidence base from controlled trials. In this Review, we discuss the main issues with regard to the diagnosis and treatment options available. We also suggest key considerations for future trials and highlight the importance of a comprehensive approach to the assessment and management of this Syndrome.

  • rufinamide for generalized seizures associated with Lennox Gastaut Syndrome
    Neurology, 2008
    Co-Authors: Tracy A Glauser, G Kluger, R Sachdeo, Gregory L Krauss, Carlos Perdomo, S Arroyo
    Abstract:

    Background: LennoxGastaut Syndrome is a catastrophic pediatric epilepsy Syndrome characterized by multiple types of treatment-resistant seizures and high rates of seizure-related injury. Current available treatments are inadequate, leaving patients with few treatment options and opportunities. Methods: We conducted a double-blind, randomized, placebo-controlled trial of the antiepileptic drug rufinamide in patients with LennoxGastaut Syndrome. Eligible patients between 4 and 30 years of age had multiple types of seizures (including tonic–atonic and atypical absence seizures) with a minimum of 90 seizures in the month before baseline and a recent history of a slow spike-and-wave pattern on EEG. Results: After a 28-day baseline period, 139 eligible patients were randomized; 138 patients received either rufinamide (n = 74) or placebo (n = 64) in addition to their other antiepileptic drugs. The median percentage reduction in total seizure frequency was greater in the rufinamide therapy group than in the placebo group (32.7% vs 11.7%, p = 0.0015). There was a difference ( p p = 0.0041) and a higher 50% responder rate compared with placebo for total seizures ( p = 0.0045) and tonic–atonic seizures ( p = 0.002). The common adverse events (reported by ≥10% of patients receiving rufinamide) were somnolence (24.3% with rufinamide vs 12.5% with placebo) and vomiting (21.6% vs 6.3%). Conclusions: Rufinamide was an effective and well-tolerated treatment for seizures associated with LennoxGastaut Syndrome.