A Study of OV101 in Individuals With Fragile X Syndrome

Fragile X Syndrome (FXS) Clinical Trial

— ROCKET  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03697161
• Other study ID #: OV101-17-001
• Status: Completed
• Phase: Phase 2
• Start date: September 17, 2018
• Est. completion date: February 26, 2020

Study information

• Verified date: December 2023
• Source: Ovid Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: February 26, 2020
• Est. primary completion date: February 3, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 13 Years to 22 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fragile X Syndrome
• Fragile X Syndrome (FXS)
• Syndrome

Intervention

Drug:
• OV101 (gaboxadol)
OV101 (gaboxadol)

Locations

Country	Name	City	State
United States	Ovid Therapeutics Investigative Site	Aurora	Colorado
United States	Ovid Therapeutics Investigative Site	Baltimore	Maryland
United States	Ovid Therapeutics Investigative Site	Chicago	Illinois
United States	Ovid Therapeutics Investigative Site	Cincinnati	Ohio
United States	Ovid Therapeutics Investigative Site	Nashville	Tennessee
United States	Ovid Therapeutics Investigative Site	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
Ovid Therapeutics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Clinical Global Impressions- Improvement (CGI-I)		Week 12
Primary	Number of Participants With Treatment Emergent Adverse Events (TEAE)	Number of Participants with Treatment Emergent Adverse Events	Week 12