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EpilepsyPhase 4NCT00552526

Ketogenic Diet vs.Antiepileptic Drug Treatment in Drug Resistant Epilepsy

A Phase 4 study testing Ketogenic diet and Antiepileptic drug (AED) in people with Epilepsy and Mental Retardation, run by Oslo University Hospital at 1 site in Norway.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 2 to 15 years
Conditions the study is for
Epilepsy, Mental Retardation
What is being tested?
Ketogenic diet and Antiepileptic drug (AED)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteNorway
Study dates
Nov 2007to Dec 2013
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 15 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • SSE, Nevrological dep. , Rikshospitalet University hospital

    Oslo

Other trials in Norway

About this study

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

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.

Read the 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
Being tested
Ketogenic diet, Antiepileptic drug (AED)
Keywords
Epilepsy, Children, Mental retardation, Ketogenic diet, Diet
Medical subject headings
Epilepsy, Intellectual Disability

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ketogenic dietDietary supplement

    Ketogenic diet is a very strict high fat 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.

Study groups in NCT00552526
Study groupRoleWhat they receive
Ketogenic dietActive comparatorNot described
Receives: Dietary Supplement: Ketogenic diet
AEDActive comparatorMost appropriate antiepileptic drug
Receives: Drug: Antiepileptic drug (AED)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 4 months

Secondary outcomes (5)

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

    Measured: Four months

  2. Comparing side effects between the two groups

    Measured: Four months

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

    Measured: Four months

  4. 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

    Measured: 13 months

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

    Measured: 4 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2007 (estimated)
  2. Study startNov 2007
  3. Primary completionJan 2011 (estimated)
  4. Study completionDec 2013 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00552526
Sponsor's protocol ID
Ketogenic diet
Other IDs
EudraCT:2006-001776-20
Status last verified
Mar 2009
First submitted
31 Oct 2007
Last updated
19 Mar 2009
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 11368482

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

  • 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.

    PubMed 15679509

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

    PubMed 12917915

  • 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.

    PubMed 15679508

  • 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.

    PubMed 11986436

  • 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.

    PubMed 10742367

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ketogenic diet and Antiepileptic drug (AED) in people with Epilepsy and Mental Retardation, run by Oslo University Hospital at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparing amount of patients with 100%, >90% and >50% reduction in number of seizures between the two groups of seizures (time frame: 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00552526, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2009.

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