A Randomized, Double-Blind, Placebo-Controlled Multiple-Center, Efficacy and Safety Study of ZYN002 Administered as a Transdermal Gel to Children, Adolescents, and Young Adults with Fragile X Syndrome - RECONNECT
This research study, called RECONNECT, is looking into a new gel treatment for Fragile X syndrome (FXS). The gel, named ZYN002, contains CBD and is applied to the skin. The study wants to find out if this gel can help improve social avoidance and other common challenges faced by children, teenagers, and young adults with FXS. Participants will receive either the active CBD gel or a dummy gel (placebo) without knowing which one they have. The researchers will then carefully compare how these groups change over 18 weeks to understand if ZYN002 is safe and effective.
At a glance
What is this study about?
This study is called RECONNECT, and it's looking for new ways to help people with Fragile X syndrome (FXS). FXS is a genetic condition that can affect a person's learning, behaviour, and how they interact with others. One common challenge for people with FXS is social avoidance, meaning they might find it difficult or uncomfortable to be around other people.
The main aim of this study is to test a new treatment called ZYN002. This is a gel that contains CBD (cannabidiol), which is applied to the skin. Researchers want to see if applying this gel regularly can help reduce social avoidance and other related behaviours in children, teenagers, and young adults with FXS. They will also be looking at how safe the gel is to use.
To make sure the results are fair and accurate, the study is set up in a special way. Some participants will receive the active ZYN002 gel, while others will receive a 'dummy' gel (called a placebo) that looks and feels the same but doesn't contain the active ingredient. Neither the participants nor their doctors will know who is getting which gel until the study is over. This helps to get a clear picture of whether the ZYN002 gel truly makes a difference.
Key takeaways
- Tests a CBD gel (ZYN002) for Fragile X syndrome.
- Aims to improve social avoidance and other behaviours.
- Involves children, teenagers, and young adults (18+).
- Compares active gel to a dummy gel (placebo).
- Main treatment period is 18 weeks.
- Focuses on safety and how well the treatment works.
Who may be eligible?
This study is looking for children, teenagers, and young adults who have been diagnosed with Fragile X syndrome (FXS). To be considered, participants must be at least 18 years old. There isn't an upper age limit mentioned, so adults of any age might be able to take part if they meet other criteria.
Researchers will also check specific genetic information about your Fragile X syndrome. Some parts of the study are particularly interested in people who have a 'complete methylation' of a specific gene called FMR1, but other parts of the study will include all participants with Fragile X syndrome regardless of this detail.
Both males and females are welcome to participate in this research. The study will have other specific medical requirements, which will be discussed with you by the study team to ensure it's safe for you to take part.
- Do you have a diagnosis of Fragile X syndrome?
- Are you 18 years old or older?
- Are you able to attend regular study appointments?
- Are you comfortable with applying a gel to the skin?
- Are you currently receiving treatment that won't interfere with the study?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to join the study, you would regularly apply a gel to your skin – either the active ZYN002 gel or a dummy gel – for 18 weeks (about 4.5 months). Neither you nor your doctor will know which gel you are using. You would need to attend appointments at a study clinic at different times during these 18 weeks, and possibly before and after, for assessments. These assessments will involve checking your health, discussing any changes in behaviour or mood, and completing questionnaires. There would also be follow-up checks after the main treatment period to see how you are doing. The total duration of your involvement could be several months, including the treatment and follow-up stages.
Potential risks and benefits
Locations (1)
- —Ireland
Common questions
What is Fragile X syndrome?
Fragile X syndrome is a genetic condition that can cause developmental and learning challenges, as well as behavioural difficulties, including issues with social interaction.
What is ZYN002?
ZYN002 is a gel applied to the skin that contains CBD (cannabidiol), which is derived from the cannabis plant. It's being tested as a potential treatment for Fragile X syndrome.
What is a 'placebo'?
A placebo is a 'dummy' treatment that looks and feels exactly like the active treatment but doesn't contain any active medicine. It helps researchers compare results fairly.
How long will the study last?
The main treatment part of the study lasts for 18 weeks (about 4.5 months), but your total involvement, including initial checks and follow-up, could be longer.
Will I know if I'm getting the real gel or the dummy gel?
No, neither you nor your doctors will know which gel you are receiving until the study is finished. This is to ensure the results are as unbiased as possible.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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