Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT04302116
NA

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

Sponsor: Kullasate Sakpichaisakul

View on ClinicalTrials.gov

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

Interventions

DRUG

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

DRUG

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