NCT05751525 Impact of Sulphonylureas on Neurodevelopmental Outcomes in KCNJ11-related Intermediate Developmental Delay, Epilepsy and Neonatal Diabetes (iDEND) Syndrome
| NCT ID | NCT05751525 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Royal Devon and Exeter NHS Foundation Trust |
| Condition | Neurodevelopmental Disorders |
| Study Type | OBSERVATIONAL |
| Enrollment | 21 participants |
| Start Date | 2016-07-01 |
| Primary Completion | 2025-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 21 participants in total. It began in 2016-07-01 with a primary completion date of 2025-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this observational study is to learn about the impact of the diabetes drug glibenclamide (glyburide) on neurodevelopment in individuals with iDEND (developmental delay, epilepsy and neonatal diabetes) due to the V59M mutation in the KCNJ11 gene. The main question it aims to answer is whether initiating sulphonylurea (SU) therapy in the first year of life results in better neurodevelopmental outcomes in affected individuals, in comparison to starting therapy later than 12 months of age. Participants will undergo a neurodevelopmental assessment comprising parental and teacher completion of standardised questionnaires, and where possible face to face neuropsychological testing. Researchers will compare the outcomes of these standardised tests in the individuals who started SU therapy \<12 months of age in comparison to those who started \>12 months of age.
Eligibility Criteria
Inclusion Criteria: * Current age ≥2 years * Heterozygous for a V59M mutation in the KCNJ11 gene * Successfully transferred to oral sulphonylurea therapy * Willing to participate Exclusion Criteria: * Never able to transfer to oral sulphonylurea therapy * Unwilling to participate
Contact & Investigator
Dr Pamela Bowman, MBBS MSc PhD
✉ P.Bowman@exeter.ac.ukProf Andrew Hattersley
PRINCIPAL INVESTIGATOR
University of Exeter / Royal Devon University Healthcare Trust
Frequently Asked Questions
Who can join the NCT05751525 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 50 Years, studying Neurodevelopmental Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05751525 currently recruiting?
Yes, NCT05751525 is actively recruiting participants. Contact the research team at P.Bowman@exeter.ac.uk for enrollment information.
Where is the NCT05751525 trial being conducted?
This trial is being conducted at Chicago, United States, Rome, Italy, Bergen, Norway, Exeter, United Kingdom.
Who is sponsoring the NCT05751525 clinical trial?
NCT05751525 is sponsored by Royal Devon and Exeter NHS Foundation Trust. The principal investigator is Prof Andrew Hattersley at University of Exeter / Royal Devon University Healthcare Trust. The trial plans to enroll 21 participants.