A Study of OV101 in Individuals With Fragile X Syndrome

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

October 1, 2018

First Posted Date ^ICMJE

October 5, 2018

Last Update Posted Date

October 5, 2018

Actual Study Start Date ^ICMJE

September 17, 2018

Estimated Primary Completion Date

July 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Incidence of adverse events[ Time Frame: Change from baseline to week 12 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Aberrant Behavior Checklist- Community (ABC-C)[ Time Frame: Change from baseline to week 12 ]

Descriptive Information

Brief Title ^ICMJE

A Study of OV101 in Individuals With Fragile X Syndrome

Official Title ^ICMJE

A Phase 2, Randomized, Double-Blind, Parallel-Group Study Evaluating the Safety, Tolerability, and Efficacy of OV101 in Fragile X Syndrome

Brief Summary

The purpose of this study is to assess the safety, tolerability and efficacy of oral OV101 (gaboxadol) in subjects with Fragile X syndrome.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

Drug: OV101 (gaboxadol)
OV101 (gaboxadol)

Study Arms

Experimental: OV101 (gaboxadol) Regimen 1
Once Daily
Experimental: OV101 (gaboxadol) Regimen 2
Twice Daily
Experimental: OV101 (gaboxadol) Regimen 3
Three Times Daily

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

September 2019

Estimated Primary Completion Date

July 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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 participation - Clinically significant lab abnormalities or vital signs at the time of screening - History of uncontrollable seizure disorder or seizure episodes within 6 months of screening or change in the anticonvulsant pharmacotherapy in the past 3 months. - Unable or does not have a caregiver able to comply with study requirements. - Enrolled in any clinical trial within the 30 days before screening.

Sex/Gender

Sexes Eligible for Study:

Male

Ages

13 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

Ovid Therapeutics Inc.

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director: Amit Rakhit, MD Ovid Therapeutics

PRS Account

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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