Last updated: August 24, 2021
Sponsor: Kullasate Sakpichaisakul
Overall Status: Active - Recruiting
Phase
N/A
Condition
Pain (Pediatric)
Treatment
N/AClinical Study ID
NCT04302116
QSNICH63-008
Ages 2-14 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age at 2-14 months at date of enrollment
- Clinical diagnosis of infantile spasm assessed by pediatric neurologist andhypsarrhythmic pattern or variants interpreted by pediatric epileptologist
- Thai nationality
Exclusion
Exclusion Criteria:
- Previous treatment (within the last 28 days) with vigabatrin or corticosteroid
- Previous diagnosis of epileptic encephalopathy e.g. early infantile epilepticencephalopathy and early myoclonic epileptic encephalopathy
- Has a clinical suspicious or diagnosis of tuberous sclerosis complex characterized byone of these; known affected parent, previously diagnosed cardiac rhabdomyoma,hypomelanotic macules, forehead fibrous plaque, shagreen patch, retinal phakoma, orknown polycystic kidneys
- A contraindication to vigabatrin or corticosteroid such as recent varicella or herpeszoster infection, gastrointestinal hemorrhage etc.
- Thai language ability of the parents or guardians is that they may not understand whatis being requested of them.
- Predictable lack of availability of follow up
Study Design
Total Participants: 250
Study Start date:
May 18, 2020
Estimated Completion Date:
December 31, 2026
Study Description
Connect with a study center
Queen Sirikit National Institute of Child Health
Ratchathewi, Bangkok 10400
ThailandActive - Recruiting


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