BACKGROUND: @entity48261 is a novel antiepileptic drug for the treatment of @entity235 @entity3762 . The present study was conducted to demonstrate superior antiepileptic activity of a high dose of 30 mg/kg @entity68173 over a low dose of 1 mg/kg @entity68173 of @entity48261 during 12 weeks of treatment under double blind conditions in a field population of @entity235 with previously untreated @entity302 . In a consecutive 12 weeks open label follow up (phase 2), all animals received 30 mg/kg @entity68173 , to evaluate the persistence of the antiepileptic activity, and to evaluate the effect of a dose step up to 30 mg/kg in the former low-dose animals. RESULTS: A treatment with 30 mg/kg @entity68173 resulted in a significantly greater reduction in monthly @entity410 frequency relative to baseline data as compared to the 1 mg/kg dose. Both generalized and partial @entity410 but not cluster @entity410 were significantly less frequent in the high dose group. The antiepileptic activity was maintained during study phase 2 in the high dose group. An increase to 30 mg/kg @entity68173 in the low- dose animals resulted in a significant reduction in generalized and partial @entity410 , but not cluster @entity410 . At the end of study phase 2, 32.1 and 46.8 % of @entity235 of the former high and former low-dose groups respectively, remained free of generalized @entity410 . @entity48261 was well tolerated. The frequency of @entity235 with any @entity137 was higher in the 30 mg/kg @entity68173 dose (59 % vs. 41 %, p = 0.041), and the main target organ was the central nervous system (CNS). The occurrence of CNS related adverse reactions was transient and findings were mostly restricted to the first weeks of treatment. No hepatic enzyme increase and no other organ @entity137 were observed. CONCLUSION: The administration of @entity48261 twice daily at a dose of 30 mg/kg results in significant and persistent antiepileptic effects in @entity1 with newly diagnosed @entity302 and generalized @entity410 , as observed over a study period of up to 6 months. @entity48261 was well tolerated. Most CNS related @entity137 were transient. Both the antiepileptic activity and the safety profile make the drug suitable for long-term clinical use.

Efficacy, safety, and tolerability of XXXX in @entity235 with newly diagnosed @entity302 in a randomized controlled clinical study with long-term follow up.

@entity1 :: ('9606', 'Species') :: ['patients'] @entity410 :: ('MESH:D012640', 'Disease') :: ['seizure', 'seizures', 'tonic-clonic seizures'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicity', 'adverse drug reactions'] @entity48261 :: ('MESH:C116306', 'Chemical') :: ['imepitoin', 'Imepitoin'] @entity235 :: ('9615', 'Species') :: ['canine', 'dogs'] @entity302 :: ('MESH:D004827', 'Disease') :: ['epilepsy'] @entity68173 :: ('100683675', 'Gene') :: ['BID'] @entity3762 :: ('MESH:C562694', 'Disease') :: ['idiopathic epilepsy']
@entity48261 :: (MESH:C116306,Chemical) :: ['imepitoin']
