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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.

Tracking Information
First Submitted Date  ICMJE October 1, 2018
First Posted Date  ICMJE October 5, 2018
Last Update Posted Date May 11, 2020
Actual Study Start Date  ICMJE September 17, 2018
Actual Primary Completion Date February 3, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 25, 2019)
Incidence of adverse events [ Time Frame: Week 12 ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 3, 2018)
Incidence of adverse events [ Time Frame: Change from baseline to week 12 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 3, 2018)
Aberrant Behavior Checklist- Community (ABC-C) [ Time Frame: Change from baseline to week 12 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 25, 2019)
Clinical Global Impressions- Improvement (CGI-I) [ Time Frame: Week 12 ]
Original Other Pre-specified Outcome Measures
 (submitted: October 3, 2018)
Clinical Global Impressions- Improvement (CGI-I) [ 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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Fragile X Syndrome (FXS)
Intervention  ICMJE Drug: OV101 (gaboxadol)
OV101 (gaboxadol)
Study Arms  ICMJE
  • Experimental: OV101 (gaboxadol) Regimen 1
    Once Daily
    Intervention: Drug: OV101 (gaboxadol)
  • Experimental: OV101 (gaboxadol) Regimen 2
    Twice Daily
    Intervention: Drug: OV101 (gaboxadol)
  • Experimental: OV101 (gaboxadol) Regimen 3
    Three Times Daily
    Intervention: Drug: OV101 (gaboxadol)
Publications * Budimirovic DB, Dominick KC, Gabis LV, Adams M, Adera M, Huang L, Ventola P, Tartaglia NR, Berry-Kravis E. Gaboxadol in Fragile X Syndrome: A 12-Week Randomized, Double-Blind, Parallel-Group, Phase 2a Study. Front Pharmacol. 2021 Oct 8;12:757825. doi: 10.3389/fphar.2021.757825. eCollection 2021.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 8, 2020)
23
Original Estimated Enrollment  ICMJE
 (submitted: October 3, 2018)
30
Actual Study Completion Date  ICMJE February 26, 2020
Actual Primary Completion Date February 3, 2020   (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  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Ages  ICMJE 13 Years to 22 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03697161
Other Study ID Numbers  ICMJE OV101-17-001
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  ICMJE Not Provided
Responsible Party Ovid Therapeutics Inc.
Study Sponsor  ICMJE Ovid Therapeutics Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Amit Rakhit, MD Ovid Therapeutics Inc.
PRS Account Ovid Therapeutics Inc.
Verification Date September 2019

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