The Pharmacokinetic Study of Progesterone and Allopregnanolone in Patients with Drug-Resistant Epilepsy: A Phase II Study

Background: Progesterone, one of a class neurosteroids, has been linked to seizure control. However, the pharmacokinetics progesterone and its active metabolite, allopregnanolone, have never investigated among patients with drug-resistant epilepsy (DRE). Objective: To investigate progesterone, 400 mg micronized per oral every 12 hours for three months, DRE as an add-on therapy The pharmacokinetic parameters were examined using Phoenix WinNonlin® Software. Results: Twelve recruited. biochemical measurements serum allopregnanolone levels after taking first dose characterized by time maximum concentration (Tmax) median 1.0 2.5 hours, (Cmax) 274.97 3.81 ng/mL minimum (Cmin) 56.93 1.06 ng/mL, respectively. values during steady state follows: half-life (t1/2) 2.4 2.1 Cmax 964.35 8.92 Cmin 64.67 1.86 By examining relationship between or concentrations seizure-controlling ability, authors able identify responder patient group 5- 7-fold higher 2- 4-fold in than non-responders. Conclusion: present study revealed allopregnanolone. Moreover, could establish both which consequently relate lowering frequency DRE. Keywords: Neurosteroids; Dose regimens; Epilepsy; Pharmacokinetics; Drug-resistant