NCT00552526

Ketogenic Diet vs.Antiepileptic Drug Treatment in Drug Resistant Epilepsy

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Oslo University Hospital · Academic / Other
• Sex: All
• Age: 2 Years – 15 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Epilepsy
• Mental Retardation

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Ketogenic diet	Ketogenic diet is a very strict high fat diet
DRUG	Antiepileptic drug (AED)	An AED,not used by the patient before, which we consider to be the most appropriate will be given orally or by gastrostomy. Serum concentration, the body weight, side effects and effects on the epilepsy will be considered when deciding the dose of the AED. Traditions for amount of medicine/kg body weight or optimal serum concentration at our center will be followed. This tradition will be the same as in other major European epilepsy centers but might propose lower, but not higher amounts than recommended by the drug company. Drugs from ACT groups N03A, N05BA, N05CD, H02A or S01EC will be used including prednisolon,levetiracetam, valproate, carbamazepine, oxcarbazepine, topiramate, felbamate, zonisamide, vigabatrin, tiagabil, lamotrigine, pregabalin, rufinamide, clobazam, clonazepam, tiagabine, gabapentin, phenytoin, phenobarbital, ethosuximide, acetazolamide, nitrazepam and other new antiepileptic drugs that might be released during the study period.

Timeline

• Start date: 2007-11-01
• Primary completion: 2011-01-01
• Completion: 2013-12-01
• First posted: 2007-11-02
• Last updated: 2009-03-19

Locations

1 site across 1 country: Norway