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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04106557
Recruitment Status : Recruiting
First Posted : September 27, 2019
Last Update Posted : February 12, 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 efficacy and safety of oral OV101 (gaboxadol) in pediatric subjects with Angelman syndrome.

Condition or disease Intervention/treatment Phase
Primary Disease or Condition Being Studied: Angelman Syndrome (AS) Drug: Gaboxadol Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 9, 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: OV101 once daily (weight-based dosing) Other Name:Gaboxadol
OV101 (gaboxadol), oral, provided once daily at bedtime for 12 week duration
 Drug: Gaboxadol
OV101 versus placebo once daily at bedtime for 12 weeks
Placebo Comparator: Placebo once daily
Matching placebo,oral, provided once daily at bedtime for 12 week duration
 Drug: Placebo
Matching placebo capsules to OV101 capsules.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
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): NCT04106557


Contacts
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Contact: Ovid - Neptune US Clinical Research Referral Network Media, PA 1-855-235-3138 clinicaltrialsinquiry@ovidrx.com

Locations
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United States, Arizona
Ovid Therapeutics Investigative Site Recruiting
Phoenix, Arizona, United States, 85006
Contact: Ovid - Neptune US Clinical Research Referral Network angelmanstudy.com    855-235-3138    clinicaltrialsinquiry@ovidrx.com   
United States, California
Ovid Therapeutics Investigative Site Recruiting
San Diego, California, United States, 92024
Contact: Ovid - Neptune US Clinical Research Referral Network angelmanstudy.com    855-235-3138    clinicaltrialsinquiry@ovidrx.com   
United States, Illinois
Ovid Therapeutics Investigative Site Recruiting
Chicago, Illinois, United States, 60612
Contact: Ovid - Neptune US Clinical Research Referral Network angelmanstudy.com    855-235-3138    clinicaltrialsinquiry@ovidrx.com   
United States, Massachusetts
Ovid Therapeutics Investigative Site Recruiting
Lexington, Massachusetts, United States, 02421
Contact: Ovid - Neptune US Clinical Research Referral Network angelmanstudy.com    855-235-3138    clinicaltrialsinquiry@ovidrx.com   
United States, Pennsylvania
Ovid Therapeutics Investigative Site Recruiting
Media, Pennsylvania, United States, 19063
Contact: Ovid - Neptune US Clinical Research Referral Network angelmanstudy.com    855-235-3138    clinicaltrialsinquiry@ovidrx.com   
United States, Washington
Ovid Therapeutics Investigative Site Recruiting
Tacoma, Washington, United States, 85006
Contact: Ovid - Neptune US Clinical Research Referral Network Angelmanstudy.com    855-235-3138    clinicaltrialsinquiry@ovidrx.com   
Australia, Queensland
Ovid Therapeutics Investigative Site Recruiting
Brisbane, Queensland, Australia, 4101
Contact: Ovid - Neptune US Clinical Research Referral Network angelmanstudy.com    1-855-235-3138    clinicaltrialsinquiry@ovidrx.com   
Israel
Ovid Therapeutics Investigative Site Recruiting
Ramat Gan, Israel, 52621
Contact: Ovid - NEPTUNE angelmanstudy.com    1-855-235-3138    clinicaltrialsinquiry@ovidrx.com   
Sponsors and Collaborators
Ovid Therapeutics Inc.
More Information
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Responsible Party: Ovid Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT04106557    
Other Study ID Numbers: OV101-19-001
First Posted: September 27, 2019    Key Record Dates
Last Update Posted: February 12, 2020
Last Verified: December 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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Angelman Syndrome
Syndrome
Disease
Pathologic Processes
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
 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