Ketogenic Diet vs.Antiepileptic Drug Treatment in Drug Re... | NCT00552526

Studies
Ketogenic Diet vs.Antiepileptic Drug Treatment in Drug Resistant Epilepsy

NCT00552526

Sponsor

Oslo University Hospital

Status

Unknown status

Last Update Posted

Mar 19, 2009Estimated

Enrollment

60Estimated

Phase

Phase 4

Conditions

Epilepsy
Mental Retardation

Interventions

Ketogenic diet
Antiepileptic drug (AED)

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
EudraCT:2006-001776-20

Status Module

Record Verification Date

Mar 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2007

Primary Completion Date

Jan 2011Estimated

Completion Date

Dec 2013Estimated

First Submitted Date

Oct 31, 2007

First Submission Date that Met QC Criteria

Nov 1, 2007

First Posted Date

Nov 2, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 18, 2009

Last Update Posted Date

Mar 19, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ketogenic diet	Active Comparator		Dietary Supplement: Ketogenic diet
AED	Active Comparator	Most appropriate antiepileptic drug	Drug: Antiepileptic drug (AED)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ketogenic diet	Dietary Supplement	Ketogenic diet is a very strict high fat diet	Ketogenic diet

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Comparing amount of patients with 100%, >90% and >50% reduction in number of seizures between the two groups of seizures		4 months

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

15 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Bjorn Bjurulf, MD	SSE, Nevrological dep., Rikshospitalet University Hospital	Principal Investigator

References Module

Citations

PubMed Identifier	Type	Citation
11368482	Background	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.
	Background	Hallböök T Effects of vagus nerve stimulation and ketogenic diet on quality of life and changes in EEG and sleep Lund University 2006
15679509

ID	Term
D004827	Epilepsy
D008607	Intellectual Disability

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D019954	Neurobehavioral Manifestations

ID	Term
D055423	Diet, Ketogenic
D000927	Anticonvulsants

ID	Term
D050528	Diet, Carbohydrate-Restricted
D004035	Diet Therapy
D044623	Nutrition Therapy
D013812	Therapeutics