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Search / Trial NCT02205931

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

Epilepsy Ketogenic Diet Antiepileptic Drugs Randomised Controlled Trial

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.

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

0 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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