ROCKET Fragile X Syndrome Clinical Study

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

What is a clinical research study?

A clinical research study is a scientific test that helps determine if and how a potential medicine or treatment may work. Clinical research studies, like the ROCKET study, are monitored by the U.S. Food and Drug Administration and reviewed by independent ethics committees to safeguard the rights and welfare of research participants.

Why would someone participate in a clinical study?

People agree to participate in studies for many reasons, including the chance to help others who may be or become affected by certain conditions, give back to the scientific community, play an active role in their health and gain access to new potential medicines.

If my son qualifies for the study, do we have to participate?

No. Participating in any clinical study is completely voluntary.

What happens if we agree to participate but then change our minds?

Deciding to volunteer in a study is an important choice. If your son qualifies to participate in the ROCKET study, your study team will ensure that both of you understand the study and its possible risks and benefits. You or your son can decide to withdraw from the ROCKET study at any time.

Will I have to pay for the treatment in the ROCKET study?

No. You will not be charged for taking part in the study. The investigational medicine and care required by the study will be provided at no expense by the study sponsor, Ovid Therapeutics™. You will also be reimbursed for travel-related expenses, and travel can be arranged for you. Please talk with your study team for more information.

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.

If you arrived on this page through a MyFXResearch Portal search, you can close this window and return to your filtered results. Or start a new search here.

View More Opportunities

View All

Survey: Needs and Experiences of Families with Young Children with Fragile X

This survey will help support families in the Early Check study in NC whose newborns have been diagnosed with Fragile X and inform the design of an early intervention program for these babies.

Early Development of Young Children with Fragile X in North Carolina

RTI Int’l and UNC at Chapel Hill are conducting a research study to learn more about early development of young children with Fragile X in North Carolina, and the experiences of their parents when obtaining the diagnosis and early intervention services.