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Gaboxadol

Phase 3

Primary Disease or Condition Being Studied: Angelman Syndrome (AS) | Small molecule | Other |Ovid Therapeutics Inc.|Last Updated: Jan 8, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment104

FDA Designations

No designations recorded

Clinical trial landscape

Gaboxadol · 1 trial · 1 indication

Phase 3 1
NCT04106557A Study of OV101 in Individuals With Angelman Syndrome (AS)Primary Disease or Condition Being Studied: Angelman Syndrome (AS)
COMPLETED104 Analytics
PHASE3COMPLETED
A Study of OV101 in Individuals With Angelman Syndrome (AS)
Primary Disease or Condition Being Studied: Angelman Syndrome (AS)
NCT04106557104
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Study Endpoints

Primary Endpoints

Clinical Global Impressions- Improvement in Angelman Syndrome (CGI-I-AS) Rating at 12 Weeks
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).

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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
OV101 once daily (weight-based dosing) Other Name:GaboxadolEXPERIMENTALOV101 (gaboxadol), oral, provided once daily at bedtime for 12 week duration
Placebo once dailyPLACEBO_COMPARATORMatching placebo,oral, provided once daily at bedtime for 12 week duration

Interventions

NameTypeDescription
GaboxadolDRUGOV101 versus placebo once daily at bedtime for 12 weeks
PlaceboDRUGMatching placebo capsules to OV101 capsules.
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Eligibility Criteria

Age Range2 Years to 12 Years
SexALL
Healthy VolunteersNo
Study Sites14

Inclusion Criteria: * 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 mini...

Countries:United StatesAustraliaGermanyIsraelNetherlands
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