Ketogenic Diet in Infants With Epilepsy (KIWE)
Launched by UNIVERSITY COLLEGE, LONDON · Jul 31, 2014
Trial Information
Current as of July 21, 2025
Unknown status
Keywords
ClinConnect Summary
The project proposed is a randomised controlled multicentre study of infants with epilepsy who have failed to respond to two or more pharmacological treatments (antiepileptic drugs (AEDs) or corticosteroids), comparing ketogenic diet to treatment with a further AED.
Children for this study will be recruited from 8 paediatric neurology centres in the South of England who have an established KD service for children with epilepsy. The collaborating paediatric neurologists based in these centres are named co-applicants on this proposal. All children ages 3 to 24 months will be considered if th...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Age between 1 month and 24 months of age (not beyond second birthday at baseline).
- • 2. Diagnosis of epilepsy confirmed.
- • 3. At least an average of 4 seizures/week in baseline period.
- • 4. Failed response to previous trial of two anti-epileptic drugs. In the case of infantile spasms this could include a trial of corticosteroids.
- • 5. Children with written informed consent from parent/guardian.
- Exclusion Criteria:
- • 1. Age \<1m or \> 24 months of age
- • 2. No secure diagnosis of epilepsy
- • 3. \< 4 seizures/week on average in baseline period
- • 4. Trial of \< 2 AEDs
- • 5. Continues on corticosteroids in previous 3 months prior to randomisation
- • 6. Metabolic disease contraindicating use of the ketogenic diet e.g. pyruvate carboxylase deficiency, MCAD from previous medical investigation and screening at baseline.
- • 7. Progressive neurological disease
- • 8. Severe gastroesophageal reflux
- • 9. Previous treatment with the ketogenic diet
- • 10. Concurrent participation in another clinical trial of an investigational medicinal product.
- • 11. Patients who are prescribed AEDs not listed in the trial IMPs
About University College, London
University College London (UCL) is a leading global research institution renowned for its commitment to advancing healthcare through innovative clinical trials. As a prominent sponsor of clinical research, UCL leverages its multidisciplinary expertise and state-of-the-art facilities to conduct rigorous investigations aimed at improving patient outcomes and addressing pressing medical challenges. The institution fosters collaboration among researchers, healthcare professionals, and industry partners, ensuring that its trials adhere to the highest ethical standards and regulatory guidelines. UCL's dedication to translating scientific discoveries into practical applications underscores its role as a vital contributor to the advancement of medical science and public health.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Manchester, , United Kingdom
London, , United Kingdom
Birmingham, , United Kingdom
Bristol, , United Kingdom
Birmingham, , United Kingdom
Cambridge, , United Kingdom
Liverpool, , United Kingdom
Lancashire, , United Kingdom
Newcastle Upon Tyne, Tyne And Wear, United Kingdom
Bristol, England, United Kingdom
Liverpool, England, United Kingdom
Leeds, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
Newcastle Upon Tyne, , United Kingdom
Sheffield, , United Kingdom
Patients applied
Trial Officials
Helen Cross, FRCP(UK)
Principal Investigator
UCL Institute of Child Health
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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