By Hilary Rosselot

Zynerba Pharmaceuticals is pleased to announce a new option for families to participate in the RECONNECT trial completely from their home through a combination of at-home and virtual visits!

The at-home option is being introduced to help lessen potential barriers for families who live far from a Fragile X clinical study site or find it too challenging to go to a site for study visits. At-home and virtual visits are supported by Dr. David Kudrow and his team at Science 37.

Whether you choose for your child to participate through this new at-home option or at a Fragile X clinical study site, your participation is critical to help complete the RECONNECT trial. RECONNECT is evaluating an investigational medicine in the treatment of behavioral symptoms of Fragile X syndrome. If the data is positive, it may lead to the approval of the first medicine specifically for the treatment of behavioral symptoms in Fragile X syndrome.

Is this option right for my family?

If you have a desire for your child (age 3 through 22 years old) to participate in a clinical trial, but going to a study site may be too much of a barrier, this option may be for you.

Eligible participants living anywhere in the USA other than Alaska, Hawaii, and Washington DC may participate from their home.

How do I find out if my child is eligible to participate?

Please go to fragilexhelp.com to fill out a form to be contacted or call 833-680-1155
Qualified participates must be:

  • Between the ages of 3 to 22
  • Have a diagnosis of Fragile X syndrome through genetic testing
  • Be experiencing behavioral symptoms of Fragile X syndrome such as social anxiety/avoidance, irritability, and social unresponsiveness
  • Otherwise, be in generally good health

Will this impact the care of my child by their current doctor?

No. Your child will continue to receive care from their doctor as they currently do. The study visits are focused on conducting assessments for the study. The study doctor may share relevant information with your child’s current doctor.

What is the difference between “at-home” and “virtual” visits?

During an “at-home” visit, a study nurse will visit your home to conduct study assessments along with having some study staff who will join virtually on a call/video communication. During ‘virtual’ visits, all assessments will be done virtually through a live video communication from your home.

Can my child still enroll if I want to participate through a Fragile X clinical study site?

Yes, participation at clinical study site is still an option. You can visit the RECONNECT MyFXResearch post and complete the contact form to be connected to a site or go to the RECONNECT fragilexhelp.com website at https://bit.ly/43lkJSq to see the location of clinical study sites and fill out the contact form or call 833-680-1155 to ask about participation at a specific site.

Is the at-home option available if my child is already participating in RECONNECT?

No, your child will continue to participate at their current study site. As a reminder, current participants and any newly enrolled child who participates at a clinic study site have a combination of 4 in-clinic (office) visits and 4 virtual visits.

Who is Science 37?

Science 37 is the name of the organization providing this virtual trial option. Dr. David Kudrow is the lead investigator for Science 37 for RECONNECT and he is joined by other doctors, nurses and staff to conduct the at-home and virtual visits for the study. Science 37 has conducted many at-home studies, including studies in children, adolescents, and young adults.

about
Author Hilary Rosselot

Hilary Rosselot
Hilary joined the NFXF team in 2019. Prior to joining the NFXF team, she worked at the Cincinnati Fragile X Research and Treatment Center for over five years. She has experience as a clinical research coordinator across many types of clinical trials and served as the clinical research manager for the Cincinnati program. She earned a bachelor’s degree in psychology, a master’s, and is a SOCRA certified clinical research professional (CCRP). She enjoys time with family and friends, a great book, a strong cup of coffee and, of course, a good laugh!

learn more

Visit the RECONNECT MyFXReserach post for more infromation:

Clinical Trial RECONNECT: ZYN002 Gel | MyFXResearch Portal (fragilex.org)

Study: Mechanisms and biomarkers of disease progression in Fragile X-associated tremor/ataxia syndrome (FXTAS)

The University of Kansas BRAIN Lab is conducting a research study to learn about behavioral and brain differences associated with the Fragile X premutation. Males and females ages 50-80 living with the Fragile X premutation, with or without FXTAS, may be eligible to participate. The study includes remote & in-person visits at the University of Kansas.