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.
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.