drugset / Trial / NCT04542629
Comparative Study of Dietary and Immunological Management of Refractory Epilepsy in Children
RandomizedParallel-groupOpen-labelTreatment
Summary
1. Comparison of the efficacy of Rituximab and ketogenic diet in controlling refractory seizures versus the traditional lines as corticosteroid and trace elements. 2. Improving the management of children with refractory seizures
Timeline
- Start
- 2020-10-01
- Primary completion
- 2021-08-20
- Completion
- 2022-08-20
Publications
- Background Kwan P, Arzimanoglou A, Berg AT, Brodie MJ, Allen Hauser W, Mathern G, Moshe SL, Perucca E, Wiebe S, French J. Definition of drug resistant epilepsy: consensus proposal by the ad hoc Task Force of the ILAE Commission on Therapeutic Strategies. Epilepsia. 2010 Jun;51(6):1069-77. doi: 10.1111/j.1528-1167.2009.02397.x. Epub 2009 Nov 3.
- Background Beleza P. Refractory epilepsy: a clinically oriented review. Eur Neurol. 2009;62(2):65-71. doi: 10.1159/000222775. Epub 2009 Jun 12.
- Background Aneja S, Jain P. Refractory epilepsy in children. Indian J Pediatr. 2014 Oct;81(10):1063-72. doi: 10.1007/s12098-014-1533-1. Epub 2014 Aug 9.
- Background Dudley RW, Penney SJ, Buckley DJ. First-drug treatment failures in children newly diagnosed with epilepsy. Pediatr Neurol. 2009 Feb;40(2):71-7. doi: 10.1016/j.pediatrneurol.2008.09.021.
- Background Kalilani L, Sun X, Pelgrims B, Noack-Rink M, Villanueva V. The epidemiology of drug-resistant epilepsy: A systematic review and meta-analysis. Epilepsia. 2018 Dec;59(12):2179-2193. doi: 10.1111/epi.14596. Epub 2018 Nov 13.
- Background Berg AT, Kelly MM. Defining intractability: comparisons among published definitions. Epilepsia. 2006 Feb;47(2):431-6. doi: 10.1111/j.1528-1167.2006.00440.x.
- Background Kwan P, Brodie MJ. Early identification of refractory epilepsy. N Engl J Med. 2000 Feb 3;342(5):314-9. doi: 10.1056/NEJM200002033420503.
- Background Dlugos DJ, Sammel MD, Strom BL, Farrar JT. Response to first drug trial predicts outcome in childhood temporal lobe epilepsy. Neurology. 2001 Dec 26;57(12):2259-64. doi: 10.1212/wnl.57.12.2259.
- Background Berg AT, Shinnar S, Levy SR, Testa FM, Smith-Rapaport S, Beckerman B. Early development of intractable epilepsy in children: a prospective study. Neurology. 2001 Jun 12;56(11):1445-52. doi: 10.1212/wnl.56.11.1445.
- Background Dlugos DJ. The early identification of candidates for epilepsy surgery. Arch Neurol. 2001 Oct;58(10):1543-6. doi: 10.1001/archneur.58.10.1543.
- Background Brodie MJ, Barry SJ, Bamagous GA, Norrie JD, Kwan P. Patterns of treatment response in newly diagnosed epilepsy. Neurology. 2012 May 15;78(20):1548-54. doi: 10.1212/WNL.0b013e3182563b19. Epub 2012 May 9.
- Background Nikodijevic D, Baneva-Dolnenec N, Petrovska-Cvetkovska D, Caparoska D. Refractory Epilepsy-MRI, EEG and CT scan, a Correlative Clinical Study. Open Access Maced J Med Sci. 2016 Mar 15;4(1):98-101. doi: 10.3889/oamjms.2016.029. Epub 2016 Feb 16.
- Background Reff ME, Carner K, Chambers KS, Chinn PC, Leonard JE, Raab R, Newman RA, Hanna N, Anderson DR. Depletion of B cells in vivo by a chimeric mouse human monoclonal antibody to CD20. Blood. 1994 Jan 15;83(2):435-45.
- Background Eisenberg R, Albert D. B-cell targeted therapies in rheumatoid arthritis and systemic lupus erythematosus. Nat Clin Pract Rheumatol. 2006 Jan;2(1):20-7. doi: 10.1038/ncprheum0042.
- Background Sfikakis PP, Boletis JN, Tsokos GC. Rituximab anti-B-cell therapy in systemic lupus erythematosus: pointing to the future. Curr Opin Rheumatol. 2005 Sep;17(5):550-7. doi: 10.1097/01.bor.0000172798.26249.fc.
- Background Edwards JC, Cambridge G. B-cell targeting in rheumatoid arthritis and other autoimmune diseases. Nat Rev Immunol. 2006 May;6(5):394-403. doi: 10.1038/nri1838.
- Background Cervenka MC, Kossoff EH. Dietary treatment of intractable epilepsy. Continuum (Minneap Minn). 2013 Jun;19(3 Epilepsy):756-66. doi: 10.1212/01.CON.0000431396.23852.56.
- Background Bough KJ, Rho JM. Anticonvulsant mechanisms of the ketogenic diet. Epilepsia. 2007 Jan;48(1):43-58. doi: 10.1111/j.1528-1167.2007.00915.x.
- Background Kossoff EH, Zupec-Kania BA, Rho JM. Ketogenic diets: an update for child neurologists. J Child Neurol. 2009 Aug;24(8):979-88. doi: 10.1177/0883073809337162. Epub 2009 Jun 17.
- Background Neal EG, Chaffe H, Schwartz RH, Lawson MS, Edwards N, Fitzsimmons G, Whitney A, Cross JH. The ketogenic diet for the treatment of childhood epilepsy: a randomised controlled trial. Lancet Neurol. 2008 Jun;7(6):500-6. doi: 10.1016/S1474-4422(08)70092-9. Epub 2008 May 2.
- Background Yuen AW, Sander JW. Can magnesium supplementation reduce seizures in people with epilepsy? A hypothesis. Epilepsy Res. 2012 Jun;100(1-2):152-6. doi: 10.1016/j.eplepsyres.2012.02.004. Epub 2012 Mar 8.
- Background Hayashi M. Oxidative stress in developmental brain disorders. Neuropathology. 2009 Feb;29(1):1-8. doi: 10.1111/j.1440-1789.2008.00888.x.
- Background Kanner AM, Soto A, Gross-Kanner H. Prevalence and clinical characteristics of postictal psychiatric symptoms in partial epilepsy. Neurology. 2004 Mar 9;62(5):708-13. doi: 10.1212/01.wnl.0000113763.11862.26.
- Background van Mierlo P, Carrette E, Hallez H, Raedt R, Meurs A, Vandenberghe S, Van Roost D, Boon P, Staelens S, Vonck K. Ictal-onset localization through connectivity analysis of intracranial EEG signals in patients with refractory epilepsy. Epilepsia. 2013 Aug;54(8):1409-18. doi: 10.1111/epi.12206. Epub 2013 May 3.
- Background Salmenpera TM, Symms MR, Rugg-Gunn FJ, Boulby PA, Free SL, Barker GJ, Yousry TA, Duncan JS. Evaluation of quantitative magnetic resonance imaging contrasts in MRI-negative refractory focal epilepsy. Epilepsia. 2007 Feb;48(2):229-37. doi: 10.1111/j.1528-1167.2007.00918.x.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |
| Subject | Rituximab | Monoclonal antibody | 750 mg/m2 | Intravenous |