Status:
UNKNOWN
Comparison of Efficacy of LGIT and MAD Among Children With Drug Resistant Epilepsy
Lead Sponsor:
All India Institute of Medical Sciences
Conditions:
Drug Resistant Epilepsy
Ketogenic Dieting
Eligibility:
All Genders
1-15 years
Phase:
PHASE4
Brief Summary
To compare the efficacy of two less restrictive dietary therapies - LGIT and MAD, used for treatment of drug resistant epilepsy in children
Detailed Description
Up to one third of patients with epilepsy progress to drug resistant epilepsy (DRE). Current treatment options for DRE include epileptic surgery and dietary therapy. Classic KD (Ketogenic diet) is the...
Eligibility Criteria
Inclusion
- Children aged 1-15 years with drug resistant epilepsy
- Willing to come for regular follow-up according to study protocol Drug resistant epilepsy defined as
- Seizure frequency \>4 seizures per month, while on optimal doses of at least 2 prescribed antiepileptic drugs
- For West syndrome, drug resistant epilepsy will be defined as more than 4 clusters of spasms per month despite treatment with antiepileptic drugs and either ACTH(Adrenocorticotrophic hormone) or Vigabatrin
Exclusion
- Surgically remediable causes for DRE
- Inborn errors of metabolism
- Previously received KD, MAD or LGIT
- Known case of
- Chronic kidney disease
- Chronic liver disease/GI illness
- Congenital/acquired heart disease
- Chronic respiratory illness
Key Trial Info
Start Date :
December 26 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2019
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT03764956
Start Date
December 26 2018
End Date
December 1 2019
Last Update
September 10 2019
Active Locations (2)
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1
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, India, 110029
2
AIIMS
New Delhi, National Capital Territory of Delhi, India