Actively Recruiting
Vigabatrin With High Dose Prednisolone Combination Therapy vs Vigabatrin Alone for Infantile Spasm
Led by Kullasate Sakpichaisakul · Updated on 2021-08-25
250
Participants Needed
1
Research Sites
341 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 outcomes. Adrenocorticotrophic hormone (ACTH), or prednisolone, or vigabatrin are considered the first-line treatment individually. However, ACTH expense and availability are the barriers in developing countries including Thailand. Vigabatrin, therefore, is the first recommended by Epilepsy Society of Thailand due to ACTH unavailability. Recently, combined steroid treatments (either ACTH or high dose prednisolone) with vigabatrin are superior in cessation of spasms compared to steroid treatment alone. Thus, this study is aimed to compare the efficacy of vigabatrin with high dose prednisolone combination therapy and vigabatrin alone.
CONDITIONS
Official Title
Vigabatrin With High Dose Prednisolone Combination Therapy vs Vigabatrin Alone for Infantile Spasm
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Previous treatment within the last 28 days with vigabatrin or corticosteroid
- Previous diagnosis of epileptic encephalopathy such as early infantile epileptic encephalopathy and early myoclonic epileptic encephalopathy
- Clinical suspicion or diagnosis of tuberous sclerosis complex characterized by known affected parent, diagnosed cardiac rhabdomyoma, hypomelanotic macules, forehead fibrous plaque, shagreen patch, retinal phakoma, or known polycystic kidneys
- Contraindication to vigabatrin or corticosteroid, such as recent varicella or herpes zoster infection, gastrointestinal hemorrhage
- Parents or guardians unable to understand Thai language
- Predictable lack of availability for follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Queen Sirikit National Institute of Child Health
Ratchathewi, Bangkok, Thailand, 10400
Actively Recruiting
Research Team
K
Kullasate Sakpichaisakul, MD
CONTACT
S
Sirorat Suwannachote, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here