Ovid Therapeutics – OV101 Clinical Trial
Ovid Therapeutics is conducting a Phase 2 clinical trial for their drug OV101 in adults with Angelman syndrome. The trial will assess the safety and efficacy of the drug, which is thought to restore tonic inhibition and potentially alleviate symptoms such as gait and balance issues. The trial will last for 12 weeks and will include measures such as motor activity, sleep patterns, and behavior. Ovid Therapeutics is also working on other treatment approaches for Angelman syndrome and is committed to partnering with the community to make a difference in the lives of individuals with the condition. The trial is currently recruiting participants at various sites across the US.
Author(s): Amit Rakhit, Jeremy Levin
Publication Date: 2016-12-02
In this talk, we will be discussing the OV101 clinical trial conducted by Ovid Therapeutics. The trial focuses on the use of Gaboxadol, a compound that has shown potential in treating Angelman Syndrome. We will provide an overview of the trial, including its design, inclusion and exclusion criteria, and how to find more information about participating.
OV101 Clinical Trial
The OV101 clinical trial is a Phase 2 study conducted by Ovid Therapeutics. The trial aims to evaluate the safety and efficacy of Gaboxadol in adults with Angelman Syndrome. Gaboxadol is a compound that has previously been studied in adults with insomnia and has shown a good safety profile.
The trial is randomized and double-blind, meaning that participants are assigned to one of three treatment arms (two active doses and one placebo) by chance, and neither the participants nor the investigators know which treatment they are receiving. The trial lasts for 12 weeks, with regular visits and phone calls to monitor progress.
The trial measures various efficacy markers, including gait and balance, motor activity, sleep parameters, behavior, and health-related quality of life. These measures are designed to assess the potential impact of Gaboxadol on the symptoms of Angelman Syndrome.
Inclusion and Exclusion Criteria
To participate in the trial, individuals must be between 18 and 49 years old and have a molecular confirmation of Angelman Syndrome. They must also be on stable doses of medications and be able to swallow the study drug. Informed consent from a legally authorized representative is required.
The trial is being conducted at 15 sites across the United States, with plans to open a site in Israel in the future. The sites are listed on the Ovid Therapeutics website, and individuals can choose the site closest to them when enrolling in the trial.
For more information about the OV101 clinical trial, individuals can visit the Ovid Therapeutics website at angelmanstudy.com. The website provides details about the trial, including what to expect, treatment choices, and frequently asked questions. There is also a pre-screener available for individuals who are interested in participating.
The OV101 clinical trial conducted by Ovid Therapeutics is an important step in evaluating the potential of Gaboxadol in treating Angelman Syndrome. The trial aims to provide meaningful therapeutics to individuals with Angelman Syndrome and improve their quality of life. By partnering with the community and involving caregivers in the trial, Ovid Therapeutics is committed to making a difference in the lives of individuals with Angelman Syndrome.
- Title: Ovid Therapeutics – OV101 Clinical Trial
- Author(s): Amit Rakhit, Jeremy Levin
- Author(s)’ affiliation: Ovid Therapeutics
- Publication date: 2016-12-02
- Collection: 2016 FAST Science Summit