Evaluation of Keyo in Children With Epilepsy (NCT02915211) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Keyo in Children With Epilepsy
United Kingdom17 participantsStarted 2016-04
Plain-language summary
To evaluate the tolerance, acceptability and compliance of Keyo in 20 subjects aged 3 years and over, with intractable epilepsy or Glut-1 DS on a KD.
Who can participate
Age range
3 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 3 years and over
* Confirmed diagnosis of intractable epilepsy or Glut-1 DS
* Children must be currently established on a KD for at least 3 months, taken orally
* Written, informed consent by participant/carer
Exclusion Criteria:
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Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial is completed and was measuring things like palatability and GI tolerance of Keyo rather than seizure outcomes, does the available data suggest that children actually tolerated and stuck with this food product, and would it be relevant for my child's situation?
2My child has intractable epilepsy — given that this trial focused on a specific ketogenic diet product called Keyo, is the ketogenic diet itself something worth seriously considering as part of their treatment plan, and how does Keyo compare to other ways of doing a ketogenic diet?
3This study tracked GI tolerance and compliance through daily diaries, which sounds like it requires a lot of ongoing effort from families — realistically, how demanding is managing a ketogenic diet product like this day-to-day, and is our family in a position to handle that?
4Since this trial was listed under Glucose Transporter Type 1 Deficiency Syndrome as well as intractable epilepsy, does my child's specific diagnosis make them a particularly good or poor candidate for a ketogenic dietary approach like the one studied here?
5Because this trial has already completed and was focused on usability and tolerability rather than long-term seizure control, what do we actually know — from this study or other evidence — about whether a ketogenic diet product like Keyo leads to meaningful seizure reduction in children like mine?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.