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Completed

NCT Number: NCT03697161

A Study of OV101 in Individuals With Fragile X Syndrome

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

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Key information

Conditions

Fragile X Syndrome (FXS) Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Fragile X Syndrome Genetic Diseases, Inborn Genetic Diseases, X-Linked Heredodegenerative Disorders, Nervous System Intellectual Disability Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Sex Chromosome Disorders X-Linked Intellectual Disability

Age range

13 year–22 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Ovid Therapeutics Investigative Site, Sacramento, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

OV101 (gaboxadol)

Drug

OV101 (gaboxadol)

Primary outcomes

  1. Number of Participants With Treatment Emergent Adverse Events (TEAE)

    Time frame: Week 12

    Number of Participants with Treatment Emergent Adverse Events

Other outcomes

  1. Clinical Global Impressions- Improvement (CGI-I)

    Time frame: Week 12

Sponsors and collaborators

Lead sponsor

Healx AI

Industry

Registry information

Official study title

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

Acronym: ROCKET

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 5, 2018
Registry last updated
Jan 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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