The purpose of this study is to assess the efficacy and safety of oral OV101 (gaboxadol) in pediatric subjects with Angelman syndrome.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
104
Ovid Therapeutics Investigative Site
Phoenix, Arizona, United States
Ovid Therapeutics Investigative Site
San Diego, California, United States
Ovid Therapeutics Investigative Site
Clinical Global Impressions- Improvement in Angelman Syndrome (CGI-I-AS) Rating at 12 Weeks
To evaluate the efficacy of OV101 versus placebo as assessed by the Clinical Global Impressions-Improvement-Angelman syndrome (CGI-I-AS) score at Week 12. CGIA-I-AS scores range from 1 (very much improved), to 4 (no change), to 7 (very much worse).
Time frame: 12 weeks
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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
Ovid Therapeutics Investigative Site
Nashville, Tennessee, United States
Ovid Therapeutics Investigative Site
Tacoma, Washington, United States
Ovid Therapeutics Investigative Site
Brisbane, Queensland, Australia
...and 4 more locations