Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Ovid Therapeutics Inc.
Age
2–12
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or female and 2 to 12 years old (inclusive) at the time of informed consent
Confirmed molecular diagnosis of AS
Has a CGI-S-AS score of 3 or more at baseline.
Meets the following age-appropriate body weight criterion:
1. Subjects 2 to 3 years old must have a minimum body weight of 9 kg.
2. Subjects 4 years and older must be between 17 kg and 64 kg (inclusive).
Stable concomitant mediations for at least 4 weeks before study start
You may not be if
Any condition that would limit study participation
Clinically significant lab or vital sign abnormalities at the time of screening
Poorly controlled seizures (weekly seizures of any frequency with a duration more than 3 minutes, weekly seizures occurring more than 3 times per week, each with a duration of less than 3 minutes, or as defined by investigator assessment)
Use of prescription medications for sleep, minocycline, or levodopa within the 4 weeks prior to Day 1 or during the study. Benzodiazepines chronically administered for seizure control are permitted.
Cannot comply with protocol study assessments during screening or caregiver unable to comply with study requirements.
Enrolled in any clinical trial or used any investigational agent within the 30 days before screening or concurrently with this study.
Clareo Health | A Study of OV101 in Individuals With Angelman Syndrome (AS)
