Ketogenic Diet vs.Antiepileptic Drug Treatment in Drug Resistant Epilepsy

Epilepsy Clinical Trial

Official title: Comparing Ketogenic Diet With the Most Appropriate Antiepileptic Drug- a Randomized Study of Children With Mental Retardation and Drug Resistant Epilepsy

Status Active, not recruiting

Clinical Trial Summary

This is an open randomized controlled study in children with mental retardation and refractory epilepsy in which treatment with ketogenic diet (KD) is compared with treatment with the antiepileptic drug (AED), not tried by the patient before, which we consider to be the most appropriate AED for the patient.

Clinical Trial Description

There are two trials in the study:

• To compare the effect of the ketogenic diet with the effect of the most appropriate AED after 4 months

• To evaluate the effect of the ketogenic diet after 4 and 13 months on the children who have been randomized to this treatment, the seizure frequency is compared with the frequency before start of treatment ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsy
• Intellectual Disability
• Mental Retardation

• NCT number: NCT00552526
• Study type: Interventional
• Source: Oslo University Hospital
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: November 2007
• Completion date: December 2013