The purpose of the study is to assess the safety and tolerability of oral OV101 (gaboxadol) in adult and adolescent subjects with Angelman syndrome. In addition, several exploratory efficacy outcome measures will be investigated.
Two dosing schedules of OV101 (gaboxadol) giving as once daily or twice daily dose will be assessed against placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
88
Ovid Therapeutics Investigative Site
Phoenix, Arizona, United States
Ovid Therapeutics Investigative Site
San Diego, California, United States
Ovid Therapeutics Investigative Site
Gainesville, Florida, United States
Incidence of Adverse Events in Placebo and Active Treatment Groups
Summary of Subjects Reporting at least one Treatment Emergent Adverse Event (TEAEs), Safety Set. The table below summarizes the subjects who experienced TEAEs in the study.
Time frame: Baseline and Week 12
Incidence of Adverse Events in Placebo and Active Treatment Groups
The Treatment Emergent Adverse Event (TEAEs) Reported by ≥10% of Subjects in Any Treatment Group by Preferred Term, Safety Set.
Time frame: Baseline and Week 12
Incidence of Adverse Events in Placebo and Active Treatment Groups
Treatment-related TEAEs (Treatment Emergent Adverse Event) in ≥ 2 Subjects in OV101 Combined, Safety Set. The incidence of TEAEs assessed as treatment-related (at least possibly related to study drug, by the Investigator). Preferred Term in the table below.
Time frame: Baseline and Week 12
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Ovid Therapeutics Investigative Site
Tampa, Florida, United States
Ovid Therapeutics Investigative Site
Atlanta, Georgia, United States
Ovid Therapeutics Investigative Site
Chicago, Illinois, United States
Ovid Therapeutics Investigative Site
Boston, Massachusetts, United States
Ovid Therapeutics Investigative Site
Lexington, Massachusetts, United States
Ovid Therapeutics Investigative Site
Cincinnati, Ohio, United States
Ovid Therapeutics Investigative Site
Media, Pennsylvania, United States
...and 3 more locations