Efficacy and Safety of Levetiracetam in Children with Partial Seizures: An Open-label Trial
Purpose: To assess the efficacy and safety of levetiracetam (LEV) as adjunctive therapy in children with treatment‐resistant partial‐onset seizures. Methods: Children (aged 6–12 years) with treatment‐resistant partial‐onset seizures receiving one standard antiepileptic drug (AED) were eligible. Afte...
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| Vydáno v: | Epilepsia (Copenhagen) Ročník 43; číslo 5; s. 518 - 524 |
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| Hlavní autoři: | , , , , , , |
| Médium: | Journal Article |
| Jazyk: | angličtina |
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Boston, MA, USA
Blackwell Science Inc
01.05.2002
Blackwell |
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| ISSN: | 0013-9580, 1528-1167 |
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| Abstract | Purpose: To assess the efficacy and safety of levetiracetam (LEV) as adjunctive therapy in children with treatment‐resistant partial‐onset seizures.
Methods: Children (aged 6–12 years) with treatment‐resistant partial‐onset seizures receiving one standard antiepileptic drug (AED) were eligible. After a 4‐week baseline period, children received LEV in a 6‐week titration phase (target dose, 40 mg/kg/day) followed by an 8‐week evaluation phase. Seizure frequency during the evaluation period with individualized LEV doses (20–40 mg/kg/day) were compared with the 4‐week baseline seizure frequency. Plasma concentrations of LEV and other AEDs were determined to evaluate potential drug interactions.
Results: Twenty‐four subjects enrolled and received LEV; 23 entered the evaluation phase, and 22 completed the evaluation phase. Compared with their baseline seizure frequency, 12 (52%) of 23 subjects entering the evaluation phase had their seizure frequency decrease by >50%. Two subjects remained seizure free during the entire evaluation period. LEV did not significantly affect plasma concentrations of any concomitant AED during this study, and no alteration of mean clinical laboratory values was observed. The most commonly reported adverse events were headache, infection, anorexia, and somnolence.
Conclusions: This open‐label study of adjunctive LEV therapy (at 20–40 mg/kg/day) suggests that LEV is effective, safe, and well tolerated in children ages 6–12 years with treatment‐resistant partial‐onset seizures. A randomized, placebo‐controlled, double‐blind trial of LEV adjunctive therapy in children with treatment‐resistant partial‐onset seizures is needed and ongoing to confirm these open‐label findings. |
|---|---|
| AbstractList | Purpose:
To assess the efficacy and safety of levetiracetam (LEV) as adjunctive therapy in children with treatment‐resistant partial‐onset seizures.
Methods:
Children (aged 6–12 years) with treatment‐resistant partial‐onset seizures receiving one standard antiepileptic drug (AED) were eligible. After a 4‐week baseline period, children received LEV in a 6‐week titration phase (target dose, 40 mg/kg/day) followed by an 8‐week evaluation phase. Seizure frequency during the evaluation period with individualized LEV doses (20–40 mg/kg/day) were compared with the 4‐week baseline seizure frequency. Plasma concentrations of LEV and other AEDs were determined to evaluate potential drug interactions.
Results:
Twenty‐four subjects enrolled and received LEV; 23 entered the evaluation phase, and 22 completed the evaluation phase. Compared with their baseline seizure frequency, 12 (52%) of 23 subjects entering the evaluation phase had their seizure frequency decrease by >50%. Two subjects remained seizure free during the entire evaluation period. LEV did not significantly affect plasma concentrations of any concomitant AED during this study, and no alteration of mean clinical laboratory values was observed. The most commonly reported adverse events were headache, infection, anorexia, and somnolence.
Conclusions:
This open‐label study of adjunctive LEV therapy (at 20–40 mg/kg/day) suggests that LEV is effective, safe, and well tolerated in children ages 6–12 years with treatment‐resistant partial‐onset seizures. A randomized, placebo‐controlled, double‐blind trial of LEV adjunctive therapy in children with treatment‐resistant partial‐onset seizures is needed and ongoing to confirm these open‐label findings. To assess the efficacy and safety of levetiracetam (LEV) as adjunctive therapy in children with treatment-resistant partial-onset seizures. Children (aged 6-12 years) with treatment-resistant partial-onset seizures receiving one standard antiepileptic drug (AED) were eligible. After a 4-week baseline period, children received LEV in a 6-week titration phase (target dose, 40 mg/kg/day) followed by an 8-week evaluation phase. Seizure frequency during the evaluation period with individualized LEV doses (20-40 mg/kg/day) were compared with the 4-week baseline seizure frequency. Plasma concentrations of LEV and other AEDs were determined to evaluate potential drug interactions. Twenty-four subjects enrolled and received LEV; 23 entered the evaluation phase, and 22 completed the evaluation phase. Compared with their baseline seizure frequency, 12 (52%) of 23 subjects entering the evaluation phase had their seizure frequency decrease by >50%. Two subjects remained seizure free during the entire evaluation period. LEV did not significantly affect plasma concentrations of any concomitant AED during this study, and no alteration of mean clinical laboratory values was observed. The most commonly reported adverse events were headache, infection, anorexia, and somnolence. This open-label study of adjunctive LEV therapy (at 20-40 mg/kg/day) suggests that LEV is effective, safe, and well tolerated in children ages 6-12 years with treatment-resistant partial-onset seizures. A randomized, placebo-controlled, double-blind trial of LEV adjunctive therapy in children with treatment-resistant partial-onset seizures is needed and ongoing to confirm these open-label findings. To assess the efficacy and safety of levetiracetam (LEV) as adjunctive therapy in children with treatment-resistant partial-onset seizures.PURPOSETo assess the efficacy and safety of levetiracetam (LEV) as adjunctive therapy in children with treatment-resistant partial-onset seizures.Children (aged 6-12 years) with treatment-resistant partial-onset seizures receiving one standard antiepileptic drug (AED) were eligible. After a 4-week baseline period, children received LEV in a 6-week titration phase (target dose, 40 mg/kg/day) followed by an 8-week evaluation phase. Seizure frequency during the evaluation period with individualized LEV doses (20-40 mg/kg/day) were compared with the 4-week baseline seizure frequency. Plasma concentrations of LEV and other AEDs were determined to evaluate potential drug interactions.METHODSChildren (aged 6-12 years) with treatment-resistant partial-onset seizures receiving one standard antiepileptic drug (AED) were eligible. After a 4-week baseline period, children received LEV in a 6-week titration phase (target dose, 40 mg/kg/day) followed by an 8-week evaluation phase. Seizure frequency during the evaluation period with individualized LEV doses (20-40 mg/kg/day) were compared with the 4-week baseline seizure frequency. Plasma concentrations of LEV and other AEDs were determined to evaluate potential drug interactions.Twenty-four subjects enrolled and received LEV; 23 entered the evaluation phase, and 22 completed the evaluation phase. Compared with their baseline seizure frequency, 12 (52%) of 23 subjects entering the evaluation phase had their seizure frequency decrease by >50%. Two subjects remained seizure free during the entire evaluation period. LEV did not significantly affect plasma concentrations of any concomitant AED during this study, and no alteration of mean clinical laboratory values was observed. The most commonly reported adverse events were headache, infection, anorexia, and somnolence.RESULTSTwenty-four subjects enrolled and received LEV; 23 entered the evaluation phase, and 22 completed the evaluation phase. Compared with their baseline seizure frequency, 12 (52%) of 23 subjects entering the evaluation phase had their seizure frequency decrease by >50%. Two subjects remained seizure free during the entire evaluation period. LEV did not significantly affect plasma concentrations of any concomitant AED during this study, and no alteration of mean clinical laboratory values was observed. The most commonly reported adverse events were headache, infection, anorexia, and somnolence.This open-label study of adjunctive LEV therapy (at 20-40 mg/kg/day) suggests that LEV is effective, safe, and well tolerated in children ages 6-12 years with treatment-resistant partial-onset seizures. A randomized, placebo-controlled, double-blind trial of LEV adjunctive therapy in children with treatment-resistant partial-onset seizures is needed and ongoing to confirm these open-label findings.CONCLUSIONSThis open-label study of adjunctive LEV therapy (at 20-40 mg/kg/day) suggests that LEV is effective, safe, and well tolerated in children ages 6-12 years with treatment-resistant partial-onset seizures. A randomized, placebo-controlled, double-blind trial of LEV adjunctive therapy in children with treatment-resistant partial-onset seizures is needed and ongoing to confirm these open-label findings. Purpose: To assess the efficacy and safety of levetiracetam (LEV) as adjunctive therapy in children with treatment‐resistant partial‐onset seizures. Methods: Children (aged 6–12 years) with treatment‐resistant partial‐onset seizures receiving one standard antiepileptic drug (AED) were eligible. After a 4‐week baseline period, children received LEV in a 6‐week titration phase (target dose, 40 mg/kg/day) followed by an 8‐week evaluation phase. Seizure frequency during the evaluation period with individualized LEV doses (20–40 mg/kg/day) were compared with the 4‐week baseline seizure frequency. Plasma concentrations of LEV and other AEDs were determined to evaluate potential drug interactions. Results: Twenty‐four subjects enrolled and received LEV; 23 entered the evaluation phase, and 22 completed the evaluation phase. Compared with their baseline seizure frequency, 12 (52%) of 23 subjects entering the evaluation phase had their seizure frequency decrease by >50%. Two subjects remained seizure free during the entire evaluation period. LEV did not significantly affect plasma concentrations of any concomitant AED during this study, and no alteration of mean clinical laboratory values was observed. The most commonly reported adverse events were headache, infection, anorexia, and somnolence. Conclusions: This open‐label study of adjunctive LEV therapy (at 20–40 mg/kg/day) suggests that LEV is effective, safe, and well tolerated in children ages 6–12 years with treatment‐resistant partial‐onset seizures. A randomized, placebo‐controlled, double‐blind trial of LEV adjunctive therapy in children with treatment‐resistant partial‐onset seizures is needed and ongoing to confirm these open‐label findings. |
| Author | PELLOCK John M. FOUNTAIN Nathan B. JENSEN Christof M. GLAUSER Tracy A. BEBIN E. Martina RITTER Frank J. SHIELDS W. Donald |
| Author_xml | – sequence: 1 givenname: Tracy A. surname: Glauser fullname: Glauser, Tracy A. – sequence: 2 givenname: John M. surname: Pellock fullname: Pellock, John M. – sequence: 3 givenname: E. Martina surname: Bebin fullname: Bebin, E. Martina – sequence: 4 givenname: Nathan B. surname: Fountain fullname: Fountain, Nathan B. – sequence: 5 givenname: Frank J. surname: Ritter fullname: Ritter, Frank J. – sequence: 6 givenname: Christof M. surname: Jensen fullname: Jensen, Christof M. – sequence: 7 givenname: W. Donald surname: Shields fullname: Shields, W. Donald |
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| Keywords | Human Nervous system diseases Chemotherapy Partial Treatment efficiency Epilepsy Central nervous system disease Tolerance Anticonvulsant Child Cerebral disorder Levetiracetam |
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| Snippet | Purpose: To assess the efficacy and safety of levetiracetam (LEV) as adjunctive therapy in children with treatment‐resistant partial‐onset seizures.
Methods:... Purpose: To assess the efficacy and safety of levetiracetam (LEV) as adjunctive therapy in children with treatment‐resistant partial‐onset seizures. Methods:... To assess the efficacy and safety of levetiracetam (LEV) as adjunctive therapy in children with treatment-resistant partial-onset seizures. Children (aged 6-12... To assess the efficacy and safety of levetiracetam (LEV) as adjunctive therapy in children with treatment-resistant partial-onset seizures.PURPOSETo assess the... |
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| SubjectTerms | Age Factors Age of Onset Anorexia - chemically induced Anticonvulsants - adverse effects Anticonvulsants - blood Anticonvulsants - therapeutic use Anticonvulsants. Antiepileptics. Antiparkinson agents Biological and medical sciences Child Children Drug Administration Schedule Drug Therapy, Combination Epilepsies, Partial - blood Epilepsies, Partial - drug therapy Epilepsy Female Headache - chemically induced Headache. Facial pains. Syncopes. Epilepsia. Intracranial hypertension. Brain oedema. Cerebral palsy Humans Infection - chemically induced Keppra Levetiracetam Male Medical sciences Nervous system (semeiology, syndromes) Neurology Neuropharmacology Partial seizures Pharmacology. Drug treatments Piracetam - adverse effects Piracetam - analogs & derivatives Piracetam - blood Piracetam - therapeutic use Sleep Wake Disorders - chemically induced Treatment Outcome |
| Title | Efficacy and Safety of Levetiracetam in Children with Partial Seizures: An Open-label Trial |
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