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OV101

Phase 2

Fragile X Syndrome (FXS) | Small molecule | Other |Ovid Therapeutics Inc.|Last Updated: Jan 23, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment36

FDA Designations

No designations recorded

Clinical trial landscape

OV101 · 2 trials · 3 indications

Phase 2 1Phase 1 1
NCT03697161A Study of OV101 in Individuals With Fragile X SyndromeFragile X Syndrome (FXS)
COMPLETED36 Analytics
PHASE2COMPLETED
A Study of OV101 in Individuals With Fragile X Syndrome
Fragile X Syndrome (FXS)
NCT0369716136
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Study Endpoints

Primary Endpoints

Number of Participants With Treatment Emergent Adverse Events (TEAE)
Week 12

Number of Participants with Treatment Emergent Adverse Events

Measurement of maximum plasma concentration achieved following a single dose of OV101
10 hours

Maximum plasma concentration (Cmax)

Measurement of time of maximum plasma concentration following a single dose of OV101
10 hours

Time after administration of drug when maximum plasma concentration is reached (Tmax)

Measurement of plasma half-life following a single dose of OV101
10 hours

Plasma half-life (T1/2)

Measurement of the area under the plasma concentration versus time curve following a single dose of OV101
10 hours

Area under the curve from 0 to 10 hours (AUC 0-10)

Measurement of clearance following a single dose of OV101
10 hours

Total body clearance (CL)

Measurement of the apparent volume of distribution following a single dose of OV101
10 hours

Apparent volume of distribution during terminal phase (Vz)

Secondary Endpoints

Safety parameters, adverse events, absolute values and changes over time of hematology, clinical chemistry, urinalysis, vital signs, electrocardiogram (ECG)
10 hours
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
OV101 (gaboxadol) Regimen 1EXPERIMENTALOnce Daily
OV101 (gaboxadol) Regimen 2EXPERIMENTALTwice Daily
OV101 (gaboxadol) Regimen 3EXPERIMENTALThree Times Daily
Single-dose 5 mg OV101EXPERIMENTAL -

Interventions

NameTypeDescription
OV101 (gaboxadol)DRUGOV101 (gaboxadol)
OV101DRUGSingle-dose 5 mg OV101
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Eligibility Criteria

Age Range13 Years to 22 Years
SexMALE
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * Is male and 13 to 22 years old (inclusive) at the time of informed consent. * Has a diagnosis of FXS with a confirmed FMR1 full mutation (≥200 CGG repeats). Exclusion Criteria: * Concomitant disease or condition that are clinically significant and would limit study participa...

Countries:United States
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