In this double-blind, randomized, placebo-controlled, international study, researchers assessed the effectiveness and safety of pregabalin as adjunctive treatment for children (aged 4-16 years) with partial-onset seizures, termed focal onset seizures for this investigation. The criteria for selection included focal onset seizures and a stable regimen of 1 to 3 antiepileptic drugs. Pregabalin 2.5 mg/kg/d, 10 mg/kg/d or placebo were used in the study, with doses increased to 3.5 or 14 mg/kg/d for subjects weighing <30 kg. According to findings, pregabalin 10 mg/kg/d was effective in reducing the seizure frequency in children with focal onset seizures vs placebo, and both doses of pregabalin were generally safe and well tolerated. Common adverse events included somnolence, increased weight and increased appetite.
January 30, 2019
October 30, 2023
Neurona Therapeutics Announces Publication in Cell Stem Cell Reporting the Development of Investigational Novel Regenerative Cell Therapy Strategy for Drug-resistant Focal Epilepsy
The data support the development of Neurona Therapeutics’ regenerative cell therapy candidate, NRTX-1001, which is being evaluated in an ongoing Phase I/II clinical trial of a one-time dose in people with drug-resistant MTLE (NCT05135091).