Status:
UNKNOWN
Ketogenic Diet in Infants With Epilepsy (KIWE)
Lead Sponsor:
University College, London
Collaborating Sponsors:
Great Ormond Street Hospital for Children NHS Foundation Trust
Cambridge University Hospitals NHS Foundation Trust
Conditions:
Epilepsy
Eligibility:
All Genders
1-2 years
Phase:
PHASE4
Brief Summary
Epilepsy, a condition where individuals are prone to recurrent epileptic seizures, is the most common chronic neurological disorder in children. Epilepsy onset is most common in the first two years of...
Detailed Description
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 corticost...
Eligibility Criteria
Inclusion
- Age between 1 month and 24 months of age (not beyond second birthday at baseline).
- Diagnosis of epilepsy confirmed.
- At least an average of 4 seizures/week in baseline period.
- Failed response to previous trial of two anti-epileptic drugs. In the case of infantile spasms this could include a trial of corticosteroids.
- Children with written informed consent from parent/guardian.
Exclusion
- Age \<1m or \> 24 months of age
- No secure diagnosis of epilepsy
- \< 4 seizures/week on average in baseline period
- Trial of \< 2 AEDs
- Continues on corticosteroids in previous 3 months prior to randomisation
- Metabolic disease contraindicating use of the ketogenic diet e.g. pyruvate carboxylase deficiency, MCAD from previous medical investigation and screening at baseline.
- Progressive neurological disease
- Severe gastroesophageal reflux
- Previous treatment with the ketogenic diet
- Concurrent participation in another clinical trial of an investigational medicinal product.
- Patients who are prescribed AEDs not listed in the trial IMPs
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2019
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT02205931
Start Date
January 1 2015
End Date
June 1 2019
Last Update
May 4 2017
Active Locations (11)
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1
Birmingham Children's Hospital
Birmingham, United Kingdom, B4 6NH
2
Bristol Royal Hospital for Children
Bristol, United Kingdom, BS2 8AE
3
Addenbrooke's Hospital
Cambridge, United Kingdom, CB2 0QQ
4
Lancashire Teaching Hospitals NHS Foundation Trust
Lancashire, United Kingdom