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.
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