drugset / Trial / NCT00552526
Ketogenic Diet vs.Antiepileptic Drug Treatment in Drug Resistant Epilepsy
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2007-11
- Primary completion
- 2011-01
- Completion
- 2013-12
Publications
- 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
- 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.
- Background Levy R, Cooper P. Ketogenic diet for epilepsy. Cochrane Database Syst Rev. 2003;(3):CD001903. doi: 10.1002/14651858.CD001903.
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Acetazolamide | Small molecule | — | Oral |
| Comparator | Carbamazepine | Small molecule | — | Oral |
| Comparator | Clobazam | Small molecule | — | Oral |
| Comparator | Clonazepam | Small molecule | — | Oral |
| Comparator | Ethosuximide | Small molecule | — | Oral |
| Comparator | Felbamate | Small molecule | — | Oral |
| Comparator | Gabapentin | Small molecule | — | Oral |
| Comparator | Lamotrigine | Small molecule | — | Oral |
| Comparator | Levetiracetam | Other / unclassified | — | Oral |
| Comparator | Oxcarbazepine | Small molecule | — | Oral |
| Comparator | Phenobarbital | Unknown | — | Oral |
| Comparator | Phenytoin | Unknown | — | Oral |
| Comparator | Prednisolone | Other / unclassified | — | Oral |
| Comparator | Pregabalin | Small molecule | — | Oral |
| Comparator | Rufinamide | Small molecule | — | Oral |
| Comparator | Tiagabine | Small molecule | — | Oral |
| Comparator | Topiramate | Small molecule | — | Oral |
| Comparator | Valproate | Small molecule | — | Oral |
| Comparator | Vigabatrin | Small molecule | — | Oral |
| Comparator | Zonisamide | Other / unclassified | — | Oral |
| Comparator | nitrazepam | Small molecule | — | Oral |
| Comparator | tiagabil | Unknown | — | Oral |