Rene Andrade Machado, Edgar Bladimir Romero, Adriana Maria Goicoechea Astencio, Aisel Santos Santos, Vanessa Benjumea Cuartas and Marlene Maya Lopez
Purpose: To prove whether the use of nimodipine as add-on therapy in focal refractory epilepsy patients could improve seizure control and quality of life.
Methods: This is a randomized, unblinded, controlled trial of nimodipine as add-on therapy in adult patients
with focal refractory epilepsy. The trial consisted of baseline, maintenance and taper periods. Twenty-two patients with focal refractory epilepsy, which seizure frequency was greater than 5 per month, were randomized to one of the following dosage treatment regimens of nimodipine administered orally in four subdoses and according to body
weight: arm A, 2 mg/kg/day; arm B, 3 mg/kg/day. The primary efficacy assessment, based on change in seizure frequency, was evaluated in two ways: the 50% responder rate and seizure freedom from baseline to maintenance periods; quality of life improvement was also taken into consideration. Assessment of adverse events (AEs) was included for safety evaluation.
Results: In the intention to treat population, 7.6% of patients were seizure free for 3 months. In 16/26 patients (61.5%) seizure rate was reduced more than fifty percent. In the per protocol population 16/22 patients (72.7%) seizure rate also diminished more than fifty percent. In those patients allocated to the arm B, seizure frequency improved more than 50% in the first month of treatment. After three months of treatment, total quality of life improved significantly (p<0.05). The most frequently reported adverse events were somnolence and headache.
Conclusion: Nimodipine improves quality of life and reduced seizure rate in patients with refractory focal epilepsy.
