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NCT05751525 · ClinicalTrials.gov registry record
Impact of Sulphonylureas on Neurodevelopmental Outcomes in KCNJ11-related Intermediate Developmental Delay, Epilepsy and Neonatal Diabetes (iDEND) Syndrome
A clinical trial of Autism Spectrum Disorder and Epilepsy, sponsored by Royal Devon and Exeter NHS Foundation Trust.
- Recruiting
- Registry status
- 21
- Enrollment target
- 4
- Study locations
NCT05751525 is a study of Autism Spectrum Disorder and Epilepsy that is actively recruiting participants, run by Royal Devon and Exeter NHS Foundation Trust. The registered enrollment target is 21 participants, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (84% lower). The trial reports 4 study locations across 2 states.
The verdict
NCT05751525, a study of Autism Spectrum Disorder and Epilepsy, is actively recruiting participants, sponsored by Royal Devon and Exeter NHS Foundation Trust.
- RECRUITING
- Registry status
- 21 participants
- Enrollment target
- 4
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Sulfonylurea
Study Locations (4)
Other
- University of Rome - Rome
- University of Bergen - Bergen
- University of Exeter - Exeter
Illinois
- University of Chicago - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2016-07-01 |
| Est. Completion | 2025-12-31 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05751525
The ClinicalTrials.gov registry entry for NCT05751525 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (84% lower). The listed sponsor is Royal Devon and Exeter NHS Foundation Trust, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 6 conditions, with Autism Spectrum Disorder appearing as the primary indexed condition, and to 1 intervention - of which Sulfonylurea is the first listed.
NCT05751525 reports 4 study locations spanning 2 distinct geographic areas - top geographies include Other, Illinois.
Frequently Asked Questions
What is clinical trial NCT05751525 about?
NCT05751525 is a clinical study titled "Impact of Sulphonylureas on Neurodevelopmental Outcomes in KCNJ11-related Intermediate Developmental Delay, Epilepsy and Neonatal Diabetes (iDEND) Syndrome". 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 whe...
What is the current status of trial NCT05751525?
This trial is currently recruiting. The enrollment target is 21 participants. The study started on 2016-07-01. Estimated completion is 2025-12-31.
What conditions does trial NCT05751525 study?
This clinical trial studies the following conditions: Autism Spectrum Disorder, Epilepsy, ADHD, Neurodevelopmental Disorders, Intellectual Disability.
What interventions are being tested in trial NCT05751525?
The interventions under investigation include: Sulfonylurea (DRUG).
Who is sponsoring clinical trial NCT05751525?
This trial is sponsored by Royal Devon and Exeter NHS Foundation Trust, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05751525 being conducted?
This trial has 4 study locations across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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