5 results
Primary Objectives:• To assess the efficacy of soticlestat in reducing major motor drop (MMD) seizure frequency as add-on therapy to SOC as compared with placebo during the full treatment period (titration + maintenance).For European Medicines…
Primary Objective:To assess the long-term safety and tolerability of soticlestat when administered as adjunctive therapy to standard of care (SOC) (eg, antiseizure medications [ASMs], vagus nerve stimulation, ketogenic diet, or modified Atkins diet…
CORE PERIODPrimary:* Evaluate the safety and tolerability of up to 24 weeks of AG-348 administration in patients with pyruvate kinase deficiency (PK deficiency).Secondary:* Evaluate the pharmacokinetics (PK) of AG-348 and the metabolite AGI-8702.*…
Primary Objective The primary objective of this pilot study is to assess the ability of MV sensor driven rate adaptive atrial stimulation to restore the quality of life in CI heart failure patients.Secondary Objective(s)The secondary objectives of…
Primary Objectives:• To assess the efficacy of soticlestat in reducing convulsive seizure frequency as add-on therapy to SOC as compared with placebo during the full treatment period (titration + maintenance).• To assess the efficacy of soticlestat…