Status:
COMPLETED
A Study of OV101 in Individuals With Angelman Syndrome (AS)
Lead Sponsor:
Healx AI
Conditions:
Primary Disease or Condition Being Studied: Angelman Syndrome (AS)
Eligibility:
All Genders
2-12 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess the efficacy and safety of oral OV101 (gaboxadol) in pediatric subjects with Angelman syndrome.
Eligibility Criteria
Inclusion
- 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:
- Subjects 2 to 3 years old must have a minimum body weight of 9 kg.
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
September 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 2 2020
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT04106557
Start Date
September 9 2019
End Date
November 2 2020
Last Update
January 8 2024
Active Locations (14)
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1
Ovid Therapeutics Investigative Site
Phoenix, Arizona, United States, 85006
2
Ovid Therapeutics Investigative Site
San Diego, California, United States, 92024
3
Ovid Therapeutics Investigative Site
Chicago, Illinois, United States, 60612
4
Ovid Therapeutics Investigative Site
Boston, Massachusetts, United States, 02115