Status:
RECRUITING
Vigabatrin With High Dose Prednisolone Combination Therapy vs Vigabatrin Alone for Infantile Spasm
Lead Sponsor:
Kullasate Sakpichaisakul
Conditions:
Infantile Spasm
West Syndrome
Eligibility:
All Genders
2-14 years
Phase:
NA
Brief Summary
Infantile spasms (IS) are seizures associated with a severe infantile epileptic encephalopathy. Both cessation of spasms and electrographic response are necessary for the best neurodevelopmental outco...
Detailed Description
Infantile spasms are recognized as epileptic encephalopathy which include the hypsarrhythmia or variants electroencephalographic (EEG) features and psychomotor regression. Various underlying condition...
Eligibility Criteria
Inclusion
- Age at 2-14 months at date of enrollment
- Clinical diagnosis of infantile spasm assessed by pediatric neurologist and hypsarrhythmic pattern or variants interpreted by pediatric epileptologist
- Thai nationality
Exclusion
- Previous treatment (within the last 28 days) with vigabatrin or corticosteroid
- Previous diagnosis of epileptic encephalopathy e.g. early infantile epileptic encephalopathy and early myoclonic epileptic encephalopathy
- Has a clinical suspicious or diagnosis of tuberous sclerosis complex characterized by one of these; known affected parent, previously diagnosed cardiac rhabdomyoma, hypomelanotic macules, forehead fibrous plaque, shagreen patch, retinal phakoma, or known polycystic kidneys
- A contraindication to vigabatrin or corticosteroid such as recent varicella or herpes zoster infection, gastrointestinal hemorrhage etc.
- Thai language ability of the parents or guardians is that they may not understand what is being requested of them.
- Predictable lack of availability of follow up
Key Trial Info
Start Date :
May 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT04302116
Start Date
May 18 2020
End Date
December 1 2026
Last Update
August 25 2021
Active Locations (1)
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1
Queen Sirikit National Institute of Child Health
Ratchathewi, Bangkok, Thailand, 10400