The Contractor shall undertake performance of a clinical trial to evaluate the safety and efficacy of an investigational antiepileptic drug (ADD 94057) in a minimum of 8 patients with therapy-resistant partial seizures. This contract is one of two centers that will participate in this trial. A total of 16 patients shall be studied. Patients shall undergo a single dose pharmacokinetic study, a 32-day baseline period, followed by six, 5-week, double-blind treatment periods.
| Privitera, M D; Treiman, D M; Pledger, G W et al. (1994) Dezinamide for partial seizures: results of an n-of-1 design trial. Neurology 44:1453-8 |
