RecruitingNot ApplicableNCT04302116

Vigabatrin With High Dose Prednisolone Combination Therapy vs Vigabatrin Alone for Infantile Spasm

Efficacy of Vigabatrin With High Dose Prednisolone Combination Therapy Versus Vigabatrin Alone for Infantile Spasm: a Randomized Trial


Sponsor

Kullasate Sakpichaisakul

Enrollment

250 participants

Start Date

May 18, 2020

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 2 MonthsMax Age: 14 Months

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Combination therapy with vigabatrin and prednisolone and a drug called Vigabatrin Tablets for people with infantile spasm and west syndrome. The study is currently recruiting participants at 1 location. People eligible for this study include aged 2 Months to 14 Months.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCombination 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

DRUGVigabatrin Tablets

Vigabatrin (50-150 mg/kg/day) twice daily for 4 months


Locations(1)

Queen Sirikit National Institute of Child Health

Ratchathewi, Bangkok, Thailand

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NCT04302116


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