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A Study of OV101 in Individuals With Angelman Syndrome (AS) (NEPTUNE)

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: NCT04106557
Recruitment Status : Completed
First Posted : September 27, 2019
Last Update Posted : November 17, 2020
Sponsor:
Information provided by (Responsible Party):
Ovid Therapeutics Inc.

Tracking Information
First Submitted Date  ICMJE September 25, 2019
First Posted Date  ICMJE September 27, 2019
Last Update Posted Date November 17, 2020
Actual Study Start Date  ICMJE September 9, 2019
Actual Primary Completion Date November 2, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 27, 2019)
Clinical Global Impressions- Improvement in Angelman Syndrome (CGI-I-AS) [ Time Frame: 12 weeks ]
Clinical Global Impressions-Improvement-Angelman Syndrome (CGI-I-AS) - Scale of 1-7 reflects a spectrum where 1 is most improved, 4 is no change, and 7 is most worsened.
Original Primary Outcome Measures  ICMJE
 (submitted: September 25, 2019)
Clinical Global Impressions- Improvement in Angelman Syndrome (CGI-I-AS) [ Time Frame: 12 weeks ]
Clinical Global Impressions-Improvement-Angelman Syndrome (CGI-I-AS)
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of OV101 in Individuals With Angelman Syndrome (AS)
Official Title  ICMJE A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study to Evaluate the Efficacy and Safety of OV101 in Pediatric Individuals With Angelman Syndrome
Brief Summary The purpose of this study is to assess the efficacy and safety of oral OV101 (gaboxadol) in pediatric subjects with Angelman syndrome.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description:
Double (Participant/Care Giver and Investigator/Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Primary Disease or Condition Being Studied: Angelman Syndrome (AS)
Intervention  ICMJE
  • Drug: Gaboxadol
    OV101 versus placebo once daily at bedtime for 12 weeks
  • Drug: Placebo
    Matching placebo capsules to OV101 capsules.
Study Arms  ICMJE
  • Experimental: OV101 once daily (weight-based dosing) Other Name:Gaboxadol
    OV101 (gaboxadol), oral, provided once daily at bedtime for 12 week duration
    Intervention: Drug: Gaboxadol
  • Placebo Comparator: Placebo once daily
    Matching placebo,oral, provided once daily at bedtime for 12 week duration
    Intervention: Drug: Placebo
Publications * Not Provided

*   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: August 26, 2020)
104
Original Estimated Enrollment  ICMJE
 (submitted: September 25, 2019)
65
Actual Study Completion Date  ICMJE November 2, 2020
Actual Primary Completion Date November 2, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female and 2 to 12 years old (inclusive) at the time of informed consent
  • Confirmed molecular diagnosis of AS
  • Has a CGI-S-AS score of 3 or more at baseline.
  • Meets the following age-appropriate body weight criterion:

    1. Subjects 2 to 3 years old must have a minimum body weight of 9 kg.
    2. Subjects 4 years and older must be between 17 kg and 64 kg (inclusive).
  • Stable concomitant mediations for at least 4 weeks before study start

Exclusion Criteria:

  • Any condition that would limit study participation
  • Clinically significant lab or vital sign abnormalities at the time of screening
  • Poorly controlled seizures (weekly seizures of any frequency with a duration more than 3 minutes, weekly seizures occurring more than 3 times per week, each with a duration of less than 3 minutes, or as defined by investigator assessment)
  • Use of prescription medications for sleep, minocycline, or levodopa within the 4 weeks prior to Day 1 or during the study. Benzodiazepines chronically administered for seizure control are permitted.
  • Cannot comply with protocol study assessments during screening or caregiver unable to comply with study requirements.
  • Enrolled in any clinical trial or used any investigational agent within the 30 days before screening or concurrently with this study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Germany,   Israel,   Netherlands,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04106557
Other Study ID Numbers  ICMJE OV101-19-001
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 Not Provided
PRS Account Ovid Therapeutics Inc.
Verification Date November 2020

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