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Ketogenic Diet vs.Antiepileptic Drug Treatment in Drug Resistant Epilepsy

Primary Purpose

Epilepsy, Mental Retardation

Status

Unknown status

Phase

Phase 4

Locations

Norway

Study Type

Interventional

Intervention

Ketogenic diet

Antiepileptic drug (AED)

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring Epilepsy, Children, Mental retardation, Ketogenic diet, Diet

Eligibility Criteria

2 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

SSE, Nevrological dep. , Rikshospitalet University hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Ketogenic diet

AED

Arm Description

Most appropriate antiepileptic drug

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Comparing side effects between the two groups

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

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

Is the effect of the ketogenic diet as good in children with severe mental retardation as in children with less severe learning disabilities?

Full Information

NCT ID

NCT00552526

First Posted

October 31, 2007

Last Updated

March 18, 2009

Sponsor

Oslo University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00552526

Brief Title

Ketogenic Diet vs.Antiepileptic Drug Treatment in Drug Resistant Epilepsy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2009

Overall Recruitment Status

Unknown status

Study Start Date

November 2007 (undefined)

Primary Completion Date

January 2011 (Anticipated)

Study Completion Date

December 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Oslo University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Epilepsy, Mental Retardation

Keywords

Epilepsy, Children, Mental retardation, Ketogenic diet, Diet

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Ketogenic diet

Arm Type

Active Comparator

Arm Title

AED

Arm Type

Active Comparator

Arm Description

Most appropriate antiepileptic drug

Intervention Type

Dietary Supplement

Intervention Name(s)

Ketogenic diet

Intervention Description

Ketogenic diet is a very strict high fat diet

Intervention Type

Drug

Intervention Name(s)

Antiepileptic drug (AED)

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Time Frame

4 months

Secondary Outcome Measure Information:

Title

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

Title

Comparing side effects between the two groups

Time Frame

Four months

Title

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

Time Frame

Four months

Title

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

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bjorn Bjurulf, MD

Organizational Affiliation

SSE, Nevrological dep., Rikshospitalet University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

SSE, Nevrological dep. , Rikshospitalet University hospital

City

Oslo

Country

Norway

12. IPD Sharing Statement

Citations:

PubMed Identifier

11368482

Citation

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.

Results Reference

background

Citation

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

Results Reference

background

PubMed Identifier

15679509

Citation

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.

Results Reference

background

PubMed Identifier

12917915

Citation

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

Results Reference

background

PubMed Identifier

15679508

Citation

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.

Results Reference

background

PubMed Identifier

11986436

Citation

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.

Results Reference

background

PubMed Identifier

10742367

Citation

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.

Results Reference

background

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Ketogenic Diet vs.Antiepileptic Drug Treatment in Drug Resistant Epilepsy

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