An open-label, randomized phase II study of the efficacy and safety of indisulam (E7070) in combination with capecitabine versus capecitabine monotherapy for the treatment of metastatic breast cancer patients following prior anthracycline and taxane therapy To compare the efficacy, safety and tolerability of indisulam (I) in combination with capecitabine (C) versus capecitabine (C) monotherapy in patients with metastatic breast cancer following prior ant...

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Open label Extension Study Following Double-blind, Randomized, Placebo-controlled, Multicentre Study to Assess Efficacy and Safety of Adjunctive Zonisamide in Myoclonic Seizures associated with Idiopathic Generalized Epilepsy To assess the long-term safety of zonisamide in subjects with myoclonic seizures.

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A 2-year, Randomized, Double-blind, Placebo-controlled, Multi-center, Phase II-III Study to Evaluate the Efficacy and Safety of Oral Ranirestat (40 and 80 mg) in Mild to Moderate Diabetic Sensorimotor Polyneuropathy To determine the effect of 40 mg and 80 mg ranirestat on peroneal motor nerve conduction velocity relative to placebo in subjects with mild to moderate diabetic sensorimotor polyneuropathy

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A 52-week, multicentre, open label extension study of the safety, tolerability and efficacy of donepezil (Aricept) in Parkinson's disease patients with dementia To assess the safety and tolerability (including an assessment of motor symptoms using the UPDRS) of open label 5-10 mg/day Aricept® in Parkinson's disease patients with dementia, who have completed t...

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Estudio aleatorizado, doble ciego, controlado con placebo y de grupos paralelos con una fase de extensión abierta para evaluar el efecto de perampanel (E2007) en la cognición, el crecimiento, la seguridad, la tolerabilidad y la farmacocinética cuando se administra como terapia adyuvante en adolescentes (de 12 a menos de 18 años de edad) con crisis de inicio parcial insuficientemente controladas. A Randomized, Double-blind, Placebo-controlled, Parallel-group Study With an Open-label Extension Phase to Evaluate the Effect of Perampanel (E2007) on Cognition, Growth, Safety, Tolerability, and Pharmacokinetics When Administered as an Adjunctive Therapy in Adolescents (12 to less than 18 years of age) With Inadequately Controlled Partial-onset Seizures •Comparar el efecto a corto plazo de perampanel y placebo en la cognición empleando el sistema Cognitive Drug Research (CDR) cuando se administra como tratamiento adjuvante a adolescentes (12 a menos ...

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