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

Recruiting N/A Interventional Study
Infantile Spasm West Syndrome
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
2 Months – 14 Months
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
250 (estimated)
Sponsor
Kullasate Sakpichaisakul · Government
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About This Trial
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 cou…
Trial Locations
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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 d…
Contacts

Kullasate Sakpichaisakul, MD

66-2-354-8333

kullasate.s@rsu.ac.th

CONTACT

Sirorat Suwannachote, MD

66-2-354-8333

sirorat.s@rsu.ac.th

CONTACT