Trial record 1 of 1 for:
neptune ovid
A Study of OV101 in Individuals With Angelman Syndrome (AS) (NEPTUNE)
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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 |
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Recruitment Status :
Recruiting
First Posted : September 27, 2019
Last Update Posted : May 13, 2020
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Sponsor:
Ovid Therapeutics Inc.
Information provided by (Responsible Party):
Ovid Therapeutics Inc.
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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 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
Genetics Home Reference related topics:
Angelman syndrome
| Arm | Intervention/treatment |
|---|---|
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Experimental: OV101 once daily (weight-based dosing) Other Name:Gaboxadol
OV101 (gaboxadol), oral, provided once daily at bedtime for 12 week duration
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Drug: Gaboxadol
OV101 versus placebo once daily at bedtime for 12 weeks |
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Placebo Comparator: Placebo once daily
Matching placebo,oral, provided once daily at bedtime for 12 week duration
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Drug: Placebo
Matching placebo capsules to OV101 capsules. |
Primary Outcome Measures :
- 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.
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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.
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Meets the following age-appropriate body weight criterion:
- Subjects 2 to 3 years old must have a minimum body weight of 9 kg.
- 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.
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
| Contact: Ovid - Neptune US Clinical Research Referral Network Media, PA | 1-855-235-3138 | clinicaltrialsinquiry@ovidrx.com |
Locations
| 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 |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Ovid - Neptune US Clinical Research Referral Network Angelmanstudy.com 855-235-3138 clinicaltrialsinquiry@ovidrx.com | |
| 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, North Carolina | |
| Ovid Therapeutics Investigative Site | Recruiting |
| Carrboro, North Carolina, United States, 27510 | |
| Contact: Ovid - Neptune US Clinical Research Referral Network angelmanstudy.com 855-235-3138 clinicaltrialsinquiry@ovidrx.com | |
| United States, Ohio | |
| Ovid Therapeutics Investigative Site | Recruiting |
| Cincinnati, Ohio, United States, 45229 | |
| 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 | |
| Australia, Victoria | |
| Ovid Therapeutics Investigative Site | Recruiting |
| Heidelberg, Victoria, Australia, 3084 | |
| Contact: Ovid - Neptune US Clinical Research Referral Network Angelmanstudy.com +1-855-235-3138 clinicaltrialsinquiry@ovidrx.com | |
| Germany | |
| Ovid Therapeutics Investigative Site | Recruiting |
| Munich, Germany, 80804 | |
| 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 US Clinical Research Referral Network angelmanstudy.com +1-855-235-3138 clinicaltrialsinquiry@ovidrx.com | |
| Netherlands | |
| Ovid Therapeutics Investigative Site | Recruiting |
| Rotterdam, Netherlands, 3012CN | |
| Contact: Ovid - Neptune US Clinical Research Referral Network Angelmanstudy.com +1-855-235-3138 clinicaltrialsinquiry@ovidrx.com | |
Sponsors and Collaborators
Ovid Therapeutics Inc.
| 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: | May 13, 2020 |
| Last Verified: | December 2019 |
| 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 |