A Study in Adults and Adolescents With Angelman Syndrome (STARS)
NCT ID: NCT02996305
Last Updated: 2025-08-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
88 participants
INTERVENTIONAL
2016-01-31
2018-08-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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OV101 regimen 1
OV101 once daily
OV101 Regimen 1
OV101 regimen 2
OV101 twice daily
OV101 regimen 2
Placebo
Twice daily
Placebo
Interventions
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OV101 Regimen 1
OV101 regimen 2
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of Angelman syndrome
3. Receiving a stable regimen of concomitant medications for at least 4 weeks prior to Baseline, and able to maintain these throughout the duration of the study
4. Has a caregiver capable of providing informed consent on behalf of the subject and able to attend scheduled study visits
5. Able to ingest study medication
6. Caregivers must agree not to post any subject or study information on social media
Exclusion Criteria
2. Poorly controlled seizure activity
3. Concomitant cardiovascular, respiratory, liver, renal, or hematologic diseases of a degree that would limit participation in the study
4. Pregnancy or women of child-bearing potential who are not using and acceptable method of contraception
5. Concomitant use of minocycline, levodopa, zolpidem, zaleplon, eszopiclone, ramelteon, and cannabinoid derivatives, or any other use of any investigational agent, device, and/or investigational procedure 4 weeks prior to Baseline and during the study
6. Allergy to OV101 or any excipients
7. At increased risk of harming self and/or others based on investigator assessment
8. Any condition or reason that in the opinion of the investigator makes the subject unsuitable for enrollment
9. Inability of subject or caregiver to comply with study requirements
13 Years
49 Years
ALL
No
Sponsors
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Healx AI
INDUSTRY
Responsible Party
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Principal Investigators
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Amit Rakhit, MD, MBA
Role: STUDY_DIRECTOR
Healx AI
Locations
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Ovid Therapeutics Investigative Site
Phoenix, Arizona, United States
Ovid Therapeutics Investigative Site
San Diego, California, United States
Ovid Therapeutics Investigative Site
Gainesville, Florida, United States
Ovid Therapeutics Investigative Site
Tampa, Florida, United States
Ovid Therapeutics Investigative Site
Atlanta, Georgia, United States
Ovid Therapeutics Investigative Site
Chicago, Illinois, United States
Ovid Therapeutics Investigative Site
Boston, Massachusetts, United States
Ovid Therapeutics Investigative Site
Lexington, Massachusetts, United States
Ovid Therapeutics Investigative Site
Cincinnati, Ohio, United States
Ovid Therapeutics Investigative Site
Media, Pennsylvania, United States
Ovid Therapeutics Investigative Site
Greenwood, South Carolina, United States
Ovid Therapeutics Investigative Site
Nashville, Tennessee, United States
Ovid Therapeutics Investigative Site
Ramat Gan, , Israel
Countries
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References
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Bird LM, Ochoa-Lubinoff C, Tan WH, Heimer G, Melmed RD, Rakhit A, Visootsak J, During MJ, Holcroft C, Burdine RD, Kolevzon A, Thibert RL. The STARS Phase 2 Study: A Randomized Controlled Trial of Gaboxadol in Angelman Syndrome. Neurology. 2021 Feb 16;96(7):e1024-e1035. doi: 10.1212/WNL.0000000000011409. Epub 2020 Dec 21.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan: Study Protocol
Document Type: Statistical Analysis Plan: Statistical Analysis Plan document
Other Identifiers
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OV101-15-001
Identifier Type: -
Identifier Source: org_study_id
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