4 results
All efficacy study objectives will be assessed in the pediatric AS study population of subjects who are 4 to 12 years old. All safety study objectives will be assessed in the pediatric AS study population of subjects who are 2 to 12 years old.…
The purpose of the study is to investigate how quickly and to what extent radiprodil is absorbed and eliminated from the body (this is called pharmacokinetics). It will also be investigated to what extent radiprodil is tolerated. In addition, 2 new…
The primary objective of this study is to evaluate the long-term safety and tolerability of OV101 in individuals with AS assessed by the incidence and severity of AEs and SAEs in subjects who are at least 2 years old.The secondary objectives of this…
Primary Objective:-To determine the long-term safety and tolerability of multiple individually titrated doses of radiprodil as an addon therapy to standard of care (SOC)in pediatric participants-To establish a safe and well tolerated dose after 8…