Ketogenic Diet vs.Antiepileptic Drug Treatment in Drug Resistant Epilepsy

NCT00552526 | Unknown Phase 4 DMC

• 2 other identifiers: Ketogenic dietEudraCT:2006-001776-20
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Epilepsy; Mental Retardation

Keywords

Epilepsy; Children; Mental retardation; Ketogenic diet; Diet

Outcome Measures

Primary Outcomes (1)

• Comparing amount of patients with 100%, >90% and >50% reduction in number of seizures between the two groups of seizures

  4 months

Secondary Outcomes (5)

• Comparing the parents´evaluation of change in quality of life and cognitive function between the two groups. The parents will answer a questionary.

  Four months

• Comparing side effects between the two groups

  Four months

• Comparing change in slow activity and epileptic activity by template matching on 24 hour EEG

  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

  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?

  4 and 12 months

Study Arms (2)

Ketogenic diet

ACTIVE COMPARATOR

Dietary Supplement: Ketogenic diet

AED

ACTIVE COMPARATOR

Most appropriate antiepileptic drug

Drug: Antiepileptic drug (AED)

Interventions

Ketogenic diet DIETARY_SUPPLEMENT

Ketogenic diet is a very strict high fat diet

Ketogenic diet

Antiepileptic drug (AED) DRUG

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.

AED

Eligibility Criteria

• Age: 2 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• The patient is mentally retarded
• The patient has tried at least 3 different AED:s including one combination with two or more different AED:s.
• The parents are willing to include their child in the study after written and verbal information.
• Patients with all types of epilepsy can be included.
• The patient has at least 6 seizures/month.
• The patient is submitted to our epilepsy center.
• The seizures are possible to count
• The patient has either generalized epilepsy, multifocal epilepsy or an epilepsy where it is undetermined whether it is localized or generalized such as Dravet syndrome classified as G40.3-G40.9 in ICD X.

You may not qualify if:

• The family is expected to have compliance problems with treatment and/or seizure registration.
• The hospital which have submitted the patient is not willing to accept the inpatient stays and the procedures that are necessary for the project.
• The patient's seizures are under acceptable control.
• The patient has got a vagus nerve stimulator implanted within the last 18 months, has started a new antiepileptic drug within the last 2 months or has changed his antiepileptic drugs the last month.
• The patient has a medical condition, for example a metabolic disease, where ketogenic diet is contraindicated.
• The patient has a localized epilepsy classified as G40.0-G40.2 in ICD X.
• The patient's nutritional status is not good enough or intake of fluid is to small to permit treatment with ketogenic diet.
• The patient has within the last 2 months been using medications or herbal medications that has a considerable effect on glucose metabolism, such as oral glucocorticoids.
• The patient has within the last 2 months been using medications or herbal medications that has a considerable effect on metabolism of AED:s.
• The patient uses herbal medicine which can interact with AED or Ketogenic diet.

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

SSE, Nevrological dep. , Rikshospitalet University hospital

Oslo, Norway

Location

Related Publications (7)

• Pulsifer MB, Gordon JM, Brandt J, Vining EP, Freeman JM. Effects of ketogenic diet on development and behavior: preliminary report of a prospective study. Dev Med Child Neurol. 2001 May;43(5):301-6. doi: 10.1017/s0012162201000573.

  PMID: 11368482 BACKGROUND

• Hallböök T Effects of vagus nerve stimulation and ketogenic diet on quality of life and changes in EEG and sleep Lund University 2006

  BACKGROUND

• Kossoff EH, McGrogan JR. Worldwide use of the ketogenic diet. Epilepsia. 2005 Feb;46(2):280-9. doi: 10.1111/j.0013-9580.2005.42704.x.

  PMID: 15679509 BACKGROUND

• Levy R, Cooper P. Ketogenic diet for epilepsy. Cochrane Database Syst Rev. 2003;(3):CD001903. doi: 10.1002/14651858.CD001903.

  PMID: 12917915 BACKGROUND

• Kang HC, Kim YJ, Kim DW, Kim HD. Efficacy and safety of the ketogenic diet for intractable childhood epilepsy: Korean multicentric experience. Epilepsia. 2005 Feb;46(2):272-9. doi: 10.1111/j.0013-9580.2005.48504.x.

  PMID: 15679508 BACKGROUND

• Kossoff EH, Pyzik PL, McGrogan JR, Vining EP, Freeman JM. Efficacy of the ketogenic diet for infantile spasms. Pediatrics. 2002 May;109(5):780-3. doi: 10.1542/peds.109.5.780.

  PMID: 11986436 BACKGROUND

• Lefevre F, Aronson N. Ketogenic diet for the treatment of refractory epilepsy in children: A systematic review of efficacy. Pediatrics. 2000 Apr;105(4):E46. doi: 10.1542/peds.105.4.e46.

  PMID: 10742367 BACKGROUND

MeSH Terms

Conditions

Epilepsy; Intellectual Disability

Interventions

Diet, Ketogenic; Anticonvulsants

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Central Nervous System Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Bjorn Bjurulf, MD

  SSE, Nevrological dep., Rikshospitalet University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 31, 2007
• First Posted: November 2, 2007
• Study Start: November 1, 2007
• Primary Completion: January 1, 2011
• Study Completion: December 1, 2013
• Last Updated: March 19, 2009

Record last verified: 2009-03

Locations

NO (1)