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A Study of OV101 in Individuals With Fragile X Syndrome (ROCKET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03697161
Recruitment Status : Completed
First Posted : October 5, 2018
Last Update Posted : May 11, 2020
Sponsor:
Information provided by (Responsible Party):
Ovid Therapeutics Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Fragile X Syndrome (FXS) Drug: OV101 (gaboxadol) Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Blind, Parallel-Group Study Evaluating the Safety, Tolerability, and Efficacy of OV101 in Fragile X Syndrome
Actual Study Start Date : September 17, 2018
Actual Primary Completion Date : February 3, 2020
Actual Study Completion Date : February 26, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: OV101 (gaboxadol) Regimen 1
Once Daily
 Drug: OV101 (gaboxadol)
OV101 (gaboxadol)
Experimental: OV101 (gaboxadol) Regimen 2
Twice Daily
 Drug: OV101 (gaboxadol)
OV101 (gaboxadol)
Experimental: OV101 (gaboxadol) Regimen 3
Three Times Daily
 Drug: OV101 (gaboxadol)
OV101 (gaboxadol)


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: Week 12 ]

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

Other Outcome Measures:
  1. Clinical Global Impressions- Improvement (CGI-I) [ Time Frame: Week 12 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 22 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03697161


Locations
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United States, California
Ovid Therapeutics Investigative Site
Sacramento, California, United States, 95817
United States, Colorado
Ovid Therapeutics Investigative Site
Aurora, Colorado, United States, 80045
United States, Illinois
Ovid Therapeutics Investigative Site
Chicago, Illinois, United States, 60612
United States, Maryland
Ovid Therapeutics Investigative Site
Baltimore, Maryland, United States, 21205
United States, Ohio
Ovid Therapeutics Investigative Site
Cincinnati, Ohio, United States, 45229
United States, Tennessee
Ovid Therapeutics Investigative Site
Nashville, Tennessee, United States, 37212
Sponsors and Collaborators
Ovid Therapeutics Inc.
Investigators
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Study Director: Amit Rakhit, MD Ovid Therapeutics Inc.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ovid Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT03697161    
Other Study ID Numbers: OV101-17-001
First Posted: October 5, 2018    Key Record Dates
Last Update Posted: May 11, 2020
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fragile X Syndrome
Syndrome
Disease
Pathologic Processes
Mental Retardation, X-Linked
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Sex Chromosome Disorders
Chromosome Disorders
Congenital Abnormalities
Genetic Diseases, Inborn
 Genetic Diseases, X-Linked
Heredodegenerative Disorders, Nervous System
Gaboxadol
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action