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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Ketogenic diet is a very strict high fat diet
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.
SSE, Nevrological dep. , Rikshospitalet University hospital
Oslo, Norway
Comparing amount of patients with 100%, >90% and >50% reduction in number of seizures between the two groups of seizures
Time frame: 4 months
Comparing the parents´evaluation of change in quality of life and cognitive function between the two groups. The parents will answer a questionary.
Time frame: Four months
Comparing side effects between the two groups
Time frame: Four months
Comparing change in slow activity and epileptic activity by template matching on 24 hour EEG
Time frame: Four months
Investigating side effects and change in number of seizures, change in EEG, quality of life and cognitive function after 13 months of treatment with the ketogenic diet
Time frame: 13 months
Is the effect of the ketogenic diet as good in children with severe mental retardation as in children with less severe learning disabilities?
Time frame: 4 and 12 months
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