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Trial record 1 of 1 for:    NCT03697161
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A Study of OV101 in Individuals With Fragile X Syndrome (ROCKET)

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ClinicalTrials.gov Identifier: NCT03697161
Recruitment Status : Recruiting
First Posted : October 5, 2018
Last Update Posted : March 28, 2019
Sponsor:
Information provided by (Responsible Party):
Ovid Therapeutics Inc.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 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
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


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)




Primary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: Change from baseline to 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: Change from baseline to week 12 ]


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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.

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, Arizona
Ovid Therapeutics Investigative Site Recruiting
Phoenix, Arizona, United States, 85006
Contact: Melmed    480-443-4018    raun.melmed@melmedcenter.com   
United States, California
Ovid Therapeutics Investigative Site Recruiting
Sacramento, California, United States, 95817
Contact: Hagerman    916-703-0280    rjhagerman@ucdavis.edu   
United States, Colorado
Ovid Therapeutics Investigative Site Recruiting
Aurora, Colorado, United States, 80045
Contact: Tartaglia    720-777-8087    nicole.tartaglia@childrenscolorado.org   
United States, Illinois
Ovid Therapeutics Investigative Site Recruiting
Chicago, Illinois, United States, 60612
Contact: Berry Kravis    312-942-4036    elizabeth_berry-kravis@rush.edu   
United States, Maryland
Ovid Therapeutics Investigative Site Recruiting
Baltimore, Maryland, United States, 21205
Contact: Budimirovic    312-942-4036    budimirovic@kennedykrieger.org   
United States, Ohio
Ovid Therapeutics Investigative Site Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Dominick    312-942-4036    kelli.dominick@cchmc.org   
United States, Pennsylvania
Ovid Therapeutics Investigative Site Recruiting
Media, Pennsylvania, United States, 19063
Contact: Hatti    610-891-9699    shatti@suburbanresearch.com   
United States, Tennessee
Ovid Therapeutics Investigative Site Recruiting
Nashville, Tennessee, United States, 37212
Contact: Tanguturi    615-343-6547    yasas.c.tanguturi@vanderbilt.edu   
Sponsors and Collaborators
Ovid Therapeutics Inc.
Investigators
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Study Director: Amit Rakhit, MD Ovid Therapeutics Inc.

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Responsible Party: Ovid Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT03697161     History of Changes
Other Study ID Numbers: OV101-17-001
First Posted: October 5, 2018    Key Record Dates
Last Update Posted: March 28, 2019
Last Verified: March 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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Syndrome
Fragile X 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