The objective of the long-term extension phase is to evaluate the safety and tolerability of ruinamide as open-label adjunctive theapy, and possibly as monotherapy, in patients with inadequately controlled primary generalized, tonic-clonic (PGTC) seizures. The long-term extension phase will allow access/continued access to ruinamide therapy after completion of the double-blind treatment phase trial. Patients who complete all visits of the doubletr-blind phase treament phase of the protocol and who may benefit from treatment with ruinamide, may enter the long-term extension phase.
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