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Cognitive, adaptive, and behavioral effects of adjunctive rufinamide in Lennox-Gastaut syndrome: A prospective
Francesca Felicia Operto1, Alberto Verrotti2, Alfonso Marrelli2
1Child and Adolescent Neuropsychiatry Unit, Department of Medicine, Surgery and Dentistry, University of Salerno, Salerno, Italy.
Insights
Rufinamide (RFM) adjunctive therapy for Lennox-Gastaut syndrome (LGS) did not significantly alter cognitive, adaptive, or behavioral functions in patients after one year. This epilepsy treatment showed no negative impact on overall patient functioning.
Area of Science:
- Neurology
- Pediatric Epilepsy
- Pharmacology
Background:
- Lennox-Gastaut syndrome (LGS) is a severe, drug-resistant epilepsy in children, often leading to cognitive impairment.
- Rufinamide (RFM) is an approved adjunctive treatment for LGS seizures in patients aged 4 and older.
Purpose of the Study:
- To evaluate the 12-month effects of Rufinamide (RFM) on cognitive, adaptive, and behavioral functioning in Lennox-Gastaut syndrome (LGS) patients.
- Assess the safety and efficacy of RFM in a real-world clinical setting.
Main Methods:
- Prospective, observational, multicenter study of 16 LGS patients (aged 7-58).
- Neuropsychological evaluations (LEITER-R, Vineland, CBCL) at baseline and 12 months.
- RFM was added to existing antiepileptic drug regimens, with dosage titration.
Main Results:
- No statistically significant changes in total IQ (LEITER-R) after 12 months of RFM therapy.
- Adaptive functioning (Vineland) and emotional/behavioral profiles (CBCL) remained stable.
- No negative impact on cognitive, adaptive, or behavioral outcomes observed.
Conclusions:
- Adjunctive Rufinamide (RFM) therapy is not associated with negative effects on cognitive, adaptive, or emotional functioning in LGS patients after one year.
- RFM appears to be a safe treatment option regarding these functional domains in LGS management.
Introduction:
Lennox-Gastaut syndrome (LGS) is a severe pediatric epilepsy syndrome characterized by multiple drug-resistant seizure types. Children with LGS usually experience cognitive regression, and LGS is almost always associated with moderate to severe cognitive impairment. Rufinamide (RFM) was approved by the European Medicines Agency in 2007 for the adjunctive treatment of seizures associated with LGS in patients ≥4 years of age. The primary objective of our study was to assess cognitive, adaptive, and behavior functioning of patients with LGS after 12 months of RFM therapy.
Methods:
This was an observational, multicenter, prospective study involving 16 patients diagnosed with LGS aged between 7 and 58 years (mean = 22 ± 16.3). Fourteen of 16 patients were already on therapy with 3 antiseizure drugs and 2/16 with 4 antiseizure drugs; RFM has been added with 100 mg/week increments up to a dose of 300-2400 mg/day. The participants and their parents underwent a neuropsychological evaluation for the assessment of intellectual, adaptive, and emotional/behavioral functioning (Leiter International Performance Scale-Revised (LEITER-R), Vineland, and Child Behavior CheckList (CBCL), respectively) before the RFM introduction (baseline) and 12 months after the RFM therapy (T2). Physical and neurological examination, electroencephalography (EEG) recording, seizure type and frequency, and adverse reactions were also considered.
Results:
After 12 months, the total intelligence quotient (IQ) assessed by LEITER-R did not show statistical significant changes, such as there were no statistically significant changes in adaptive functions, assessed by Vineland. Furthermore, there were no statistically significant changes in internalizing and externalizing problems assessed by CBCL.
Conclusion:
Adjunctive treatment with RFM did not negatively affect cognitive, adaptive function, and emotional profile in patients with LGS after 1 year of follow-up.
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