Double‐Blind Study of Milacemide in Hospitalized Therapy‐Resistant Patients With Epilepsy

Abstract

Milacemide, 2-N-pentylaminoacetamide, a glycine prodrug, which readily crosses the blood-brain barrier, has been tested for antiepileptic efficacy and tolerability in 30 patients compared in a double-blind design with 30 patients treated with placebo. All patients continued to receive, without alteration, their previous partly effective medication. All patients presented an average of at least 10 seizures a month during the 6 months preceding the trial with no more than 50% fluctuation. The ratio of seizure frequency in the trial period over the seizure freuquency in the baseline period [RSF] was calculated. In the milacemide group, 9 of 29 patients had an RSF < 0.7 as opposed to 2 of 29 in the placebo group. Although no firm proof of therapeutic efficacy, this and the dramatic improvement of a patient with myoclonus epilepsy indicates that further studies are warranted. This opinion is strengthened if one considers the subgroup of patients aged .gtoreq. 25 years in which a statistically significant reduction in seizure frequency was observed with milacemide treatment. The drug was well tolerated.