| Trial name or title | Safety and Pharmacokinetic Profile of Rufinamide in Pediatric Patients Aged Less than 4 Years with Lennox‐Gastaut Syndrome: an Interim Analysis from a Multicenter, Randomized, Active‐Controlled, Open‐Label Study. |
| Methods | Randomised, active‐controlled, open‐label multi‐centre study. Number of control centres: 20. Country/location: North America and the EU. 2 treatment arms: 1 rufinamide, 1 any other approved AED. |
| Participants | Participants: children aged 1 to < 4 years. Gender: 63.9% boys; 36.1% girls. Mean age (months): 29.2 (rufinamide group 28.3; any other AED group 31.3). Inclusion criteria: aged 1 to < 4 years; clinical diagnosis of LGS, which might include the presence of multiple types of seizures progressively enriching the clinical picture, a slow background EEG rhythm, slow spike‐wave pattern (< 3 Hz) or the presence of polyspikes, or both. Exclusion criteria: diagnosed with benign myoclonic epilepsy of infancy, atypical benign focal epilepsy (pseudo‐Lennox syndrome), or continuous spike‐waves of slow sleep, as well as other epilepsy syndromes not suggesting the electroclinical profile of children within the LGS spectrum; additionally, children with familial short QT syndrome and with prior treatment with rufinamide. Comedications: ≤ 3 AEDs. Total children randomised 37: rufinamide group 25; any other approved AED group 12. 1 child assigned to any other AED group was excluded from analysis. |
| Interventions | Intervention: rufinamide up to 45 mg/kg per day. Control: any other AED. 2‐phase study: 8‐week pre‐randomisation phase included a screening period and baseline visit, and a 106‐week randomisation phase included titration and maintenance. Interim analysis at 6 months. |
| Outcomes | Primary outcomes:
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| Starting date | June 2011. |
| Contact information | aarzimanoglou@orange.fr (A. Arzimanoglou). |
| Notes | Funded by Eisai Inc. |
AED: antiepileptic drug; EEG: electroencephalogram; LGS: Lennox‐Gastaut syndrome.