A randomised controlled trial of the ketogenic diet in the treatment of epilepsy in children under the age of two years - Ketogenic diet treatment of epilepsy in infants

niversity College London0 sitesSeptember 8, 2014

Overview

No summary available.

Registry

who.int

Start Date

September 8, 2014

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

niversity College London

•1\. Age between 3 months and 24 months of age (not beyond second birthday at baseline)
•2\. Diagnosis of epilepsy confirmed
•3\. At least an average of 7 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
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 160
•F.1\.2 Adults (18\-64 years) no
•F.1\.2\.1 Number of subjects for this age range 0
•F.1\.3 Elderly (\>\=65 years) no

•1\. Age \<3m or \> 24 months of age
•2\. No secure diagnosis of epilepsy
•3\. \< 7 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.