4 results
Part 1 (phase 1b): to identify a dose of AMG 655 in combination with doxorubicin that is safe and tolerated as determined by the incidence of dose limiting toxicity Part 2 (phase2): To estimate the efficacy, as measured by progression-free survival…
Primary Objective* To demonstrate the efficacy of adjunctive perampanel therapy, compared to placebo on primary generalized tonic-clonic (PGTC)seizuresSecondary Objectives* To evaluate the safety and tolerability of perampanel in subjects with…
Primary Objective: The primary objective is to evaluate the efficacy of 2 doses ofperampanel (8 and 12 mg) in comparison to placebo given as an adjunctive therapy insubjects with refractory partial seizures.Secondary Objective: The secondary…
Primary Objective: To evaluate whether PBCC results in a reduced incidence of pulmonary hypertension in infants with CDH 24hrs after birth.Secondary Objectives: To measure and monitor physiological parameters during transition to provide information…