The ILLUMINATE Study is taking place to assess an investigational medication to measure any effects it may or may not, have on symptoms (including those affecting sleep, communication, and seizures) in people living with Rett syndrome.
FAQs
Why is this study taking place?
The ILLUMINATE Study is taking place to assess an investigational medication to measure any effects it may or may not, have on symptoms (including those affecting sleep, communication, and seizures) in people living with Rett syndrome.
What happens during the study?
If you or your loved one joins the study, here are some of the things you will be asked to do:
How long will the study last?
If you allow your loved one to join the ILLUMINATE Study—or join yourself—participation will last for about 2 years and include up to 15 study visits.* Some of these visits may take place in the participant’s home.
Participation is voluntary, and participants can leave the study at any time, for any reason.
*Please note that those who do not have access to the study drug through an alternative source (e.g., commercially available product or a managed access program) after 52 weeks in the open-label period may continue receiving it with site visits for safety assessments every 6 months until alternative access is available.
Will my loved one or I receive any study medication?
During the first part of the ILLUMINATE Study (20 weeks), you or your loved one will be screened for medical eligibility in the study and then, if eligible, randomly assigned (like the flip of a coin) to receive the investigational medication or a placebo, which looks like the study medication but contains no active medication.
If you are eligible for the second part of the study, you or your loved one will receive the study medication. No placebo will be given.
Will the device have to be returned at the end of the study?
Yes, the medication diary that you receive must be returned at the end of the study.
Can my loved one or I keep taking other medications during the study?
Participants may be able to continue the prescribed medications that they were already taking when they joined the ILLUMINATE Study but some medications cannot be taken during the study. The study team will talk to you in detail about which medications are not allowed during the study.
Are there any risks I should know about?
There are risks and discomforts in most studies, and these include risks associated with the procedures done as part of study visits. Your study team will inform you in detail about potential risks and benefits before you decide to take part, or allow your loved one to join the study. Some known risks and discomforts in the ILLUMINATE Study are:
Can my loved one and I leave the study?
Joining in a clinical study is a very personal and individual decision, so you should consider whether this is the right choice for you and your loved one. You can leave at any time without giving any reason. Deciding not to take part will not affect your or your loved one’s usual medical care now or in the future.
Will I be compensated for my participation?
The ILLUMINATE Study team is committed to supporting you and your loved one throughout study participation, so we want to make your participation as easy and stress-free as possible. Comprehensive travel, reimbursement support, and compensation may be provided for the participant and all caregivers.
Who is running this study?
The ILLUMINATE Study is sponsored by UCB, a global biopharmaceutical company based in Belgium.
How is my or my loved one’s data protected during the study?
All personal data collected for the study that can identify you or your loved one will be “coded” to remove any part of the personal data that could be used for identification. Using a code to identify study participants helps researchers keep their information confidential.
Does contacting a study center for more information mean that my loved one and I must join the study?
No. You can contact the study center to find out more about participating without any commitment. Contacting a study center does not mean that you and your loved one must or will be able to join the study.
Will I be able to have access to the results of the study?
The overall results of this study will be available on the US Food and Drug Administration’s https://www.clinicaltrials.gov database after all participants have left the study, all study data have been analyzed, and the final study report has been written. A summary of the results in plain language will be shared on the UCB website, but please note that it could take years until this is available. The study sponsor, UCB, may publish the results in an academic journal, but it will not include any information that can identify individual study participants.