NCT04302116 Vigabatrin With High Dose Prednisolone Combination Therapy vs Vigabatrin Alone for Infantile Spasm
| NCT ID | NCT04302116 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Kullasate Sakpichaisakul |
| Condition | Infantile Spasm |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2020-05-18 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 250 participants in total. It began in 2020-05-18 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Kullasate Sakpichaisakul, MD
PRINCIPAL INVESTIGATOR
Queen Sirikit National Institute of Child Health
Frequently Asked Questions
Who can join the NCT04302116 clinical trial?
This trial is open to participants of all sexes, aged 2 Months or older, up to 14 Months, studying Infantile Spasm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04302116 currently recruiting?
Yes, NCT04302116 is actively recruiting participants. Contact the research team at kullasate.s@rsu.ac.th for enrollment information.
Where is the NCT04302116 trial being conducted?
This trial is being conducted at Ratchathewi, Thailand.
Who is sponsoring the NCT04302116 clinical trial?
NCT04302116 is sponsored by Kullasate Sakpichaisakul. The principal investigator is Kullasate Sakpichaisakul, MD at Queen Sirikit National Institute of Child Health. The trial plans to enroll 250 participants.