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Vigabatrin With High Dose Prednisolone Combination Therapy vs Vigabatrin Alone for Infantile Spasm
Sponsor: Kullasate Sakpichaisakul
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.
Official title: Efficacy of Vigabatrin With High Dose Prednisolone Combination Therapy Versus Vigabatrin Alone for Infantile Spasm: a Randomized Trial
Key Details
Gender
All
Age Range
2 Months - 14 Months
Study Type
INTERVENTIONAL
Enrollment
250
Start Date
2020-05-18
Completion Date
2026-12
Last Updated
2021-08-25
Healthy Volunteers
No
Conditions
Interventions
Combination therapy with vigabatrin and prednisolone
High dose prednisolone (40 - 60 mg/day) for 1 month combined with vigabatrin treatment (50-150 mg/kg/day) twice daily for 4 months
Vigabatrin Tablets
Vigabatrin (50-150 mg/kg/day) twice daily for 4 months
Locations (1)
Queen Sirikit National Institute of Child Health
Ratchathewi, Bangkok, Thailand