Comparative Study of Dietary and Immunological Management of Refractory Epilepsy in Children

NCT04542629 | Unknown Phase 4

• 1 other identifier: CSDIMRE
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 1.Comparison of the efficacy of Rituximab and ketogenic diet in controlling refractory seizures versus the traditional lines as corticosteroid and trace elements.
2. 2.Improving the management of children with refractory seizures

Conditions

Refractory Epilepsy

Outcome Measures

Primary Outcomes (1)

• a-seizure frequency b-antiepileptic drugs c-compliance to treatment d-number of hospital admission

  number of attacks of fits during monitoring

  1 YEAR

Study Arms (4)

RITUXIMAB

EXPERIMENTAL

rituximab INTRAVENOUS 750MG/m2 every 2 weeks for 2 doses

Drug: RiTUXimab Injection [Rituxan]

KETOGENIC DIET

ACTIVE COMPARATOR

The common element of these different approaches is variable reduction in the amount of carbohydrate with appropriate increase in fat. Diets that produce a state of ketosis are referred to as ''ketogenic"

Drug: RiTUXimab Injection [Rituxan]

TRACE ELEMENTS

ACTIVE COMPARATOR

. Essential trace elements that include zinc, copper, magnesium, and selenium

Drug: RiTUXimab Injection [Rituxan]

CORTICOSTEROID

ACTIVE COMPARATOR

corticosteroid pulse therapy 30 mg /kg /day for 5 days monthly for 6 month

Drug: RiTUXimab Injection [Rituxan]

Interventions

RiTUXimab Injection [Rituxan] DRUG

375 MG/M2 /WEEK INFUSION

Also known as: KETOGENIC DIET, TRACE ELEMENTS, CORTICOSTEROID INJECTION

CORTICOSTEROID; KETOGENIC DIET; RITUXIMAB; TRACE ELEMENTS

Eligibility Criteria

• Age: 1 Month - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 1 month up to 17 years 2-Both male and female 3-Epileptic patient on two tolerated and appropriately chosen and used antiepilptic drugs with no response

You may not qualify if:

• Neonate 2-Epieptic patient on monotherapy 3-Conditions mimic epilepsy 4-Pseudo refractioness 5-Absolute contraindications for the use of diet therapy include carnitine deficiency (primary), carnitine palmitoyltransferase (CPT) I OR II deficiency, carnitine translocase deficiency, β-oxidation defects, pyruvate carboxylase deficiency, and porphyria 6-Contraindication for Rituximab:
• Hypersensitivity to any component, murine proteins. b. Heart failure c. Active infection

Sponsors & Collaborators

• Assiut University: lead

Related Publications (25)

• 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.

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• Beleza P. Refractory epilepsy: a clinically oriented review. Eur Neurol. 2009;62(2):65-71. doi: 10.1159/000222775. Epub 2009 Jun 12.

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• 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.

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• 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.

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• 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.

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• 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.

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• Kwan P, Brodie MJ. Early identification of refractory epilepsy. N Engl J Med. 2000 Feb 3;342(5):314-9. doi: 10.1056/NEJM200002033420503.

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• 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.

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• 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.

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• 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.

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• 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.

  PMID: 22573629 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.

  PMID: 27275339 BACKGROUND

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• 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.

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• 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.

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• 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.

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• 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.

  PMID: 23739109 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.

  PMID: 17241207 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.

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• 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.

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• 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.

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• 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.

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• 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.

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MeSH Terms

Conditions

Drug Resistant Epilepsy

Interventions

Rituximab; Diet, Ketogenic; Trace Elements; Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Elements; Inorganic Chemicals; Micronutrients; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Nutrients; Food; Food and Beverages; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Emad eldeen Mahmoud Hammad, professor

  aAssiut University Children Hospital

  STUDY DIRECTOR

Central Study Contacts

Duaa Mohammad Raafat Mahmoud, professor

CONTACT

01223112124; duaa-raafat@hotmail.com

Ahlam Badawy Ali Badawy, assisstant professor

CONTACT

01006807866; dr.ahlam_ali@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: September 2, 2020
• First Posted: September 9, 2020
• Study Start: October 1, 2020
• Primary Completion: August 20, 2021
• Study Completion: August 20, 2022
• Last Updated: September 9, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share