The ROCKET study is a clinical research study that will help determine if an investigational medicine, called OV101 or gaboxadol, is safe and effective in treating behavioral characteristics commonly present in people with Fragile X syndrome (FXS). The study will test three different doses of OV101.
Participation in the ROCKET study will last approximately 21 weeks and include six visits to the study medical center and four phone appointments. The study center visits will last the majority of the day.
At the clinic appointments, you will meet with your study team, which will include a study physician, nurse, and other healthcare professionals. They will explain the study, answer your questions, and monitor your care.
The phone appointments will take place between visits to the study medical center. During these calls, a study team member will ask about any changes in your son’s health and behavior. You may also discuss any side effects or new symptoms your son may be experiencing and any new medicines or vitamins he may be taking.
Eligibility
Sex: Male
Age: 13 to 22
Disorder: Confirmed diagnosis of Fragile X syndrome
He also needs to be able to swallow a capsule, or its contents when mixed with soft food; and must have a parent or caregiver who can provide consent, attend scheduled visits, and participate in study assessments and scheduled phone meetings.
U.S. Locations
- Phoenix, Arizona
- Sacramento, California
- Aurora, Colorado
- Chicago, Illinois
- Baltimore, Maryland
- Cincinnati, Ohio
- Media, Pennsylvania
- Nashville, Tennessee
Frequently Asked Questions
Contact
Luke Rosen
Director of Patient Engagement
646-930-4387
lrosen@ovidrx.com
Study Director
Amit Rakhit, M.D.
Sponsor
Ovid Therapeutics Inc.
Clinicaltrials.gov Identifier:
NCT03697161
If you’d like to learn more or apply for this opportunity, please fill out the form to send your contact information to the study coordinators.
Our Most Recent Opportunities
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Survey: How has the COVID-19 Pandemic Impacted Fragile X Families
Researchers at Teachers College at Columbia University are conducting a survey to learn about the impact that the COVID-19 pandemic has had on multiple aspects of the lives of people with Fragile X Syndrome. We want to see how the Fragile X community specifically was impacted so that we can have a more focused plan of action for helping these families. The overall goal of this survey is to distribute our findings to medical professionals so that they can see what gaps have been created in their practices from the pandemic.
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Kaylynn Shuleski, a master’s in genetic counseling candidate, is conducting a research study to explore the concerns and challenges caregivers may face when planning long-term supports and living arrangements for their adult children with Fragile X syndrome (FXS). This information will be valuable for current and future families when considering long-term supports, as well as for healthcare professionals, counselors, and policy makers. About the Study Who can participate? Parents and caregivers of adults with full mutation ...