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

Sponsor
Assiut University
Study ID
NCT04542629
Phase
PHASE4
Status
Unknown

Conditions

  • Refractory Epilepsy

Eligibility Criteria

Sex
ALL
Age
1 Month - 17 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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

Key Dates

Start date
Oct 1, 2020
Status verified
Sep 2020
Primary completion
Aug 20, 2021
Completion
Aug 20, 2022

Study Design

Enrollment
140 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: RITUXIMAB
    rituximab INTRAVENOUS 750MG/m2 every 2 weeks for 2 doses
  • Active Comparator: KETOGENIC DIET
    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"
  • Active Comparator: TRACE ELEMENTS
    . Essential trace elements that include zinc, copper, magnesium, and selenium
  • Active Comparator: CORTICOSTEROID
    corticosteroid pulse therapy 30 mg /kg /day for 5 days monthly for 6 month

Primary Outcome Measure

a-seizure frequency b-antiepileptic drugs c-compliance to treatment d-number of hospital admission [ Time Frame: 1 YEAR ]

Central Contacts

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