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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 2 months
Maximum Age: 1
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Thailand
Queen Sirikit National Institute of Child Health
RECRUITING
Ratchathewi
Contact Information
Primary
Kullasate Sakpichaisakul, MD
kullasate.s@rsu.ac.th
66-2-354-8333
Backup
Sirorat Suwannachote, MD
sirorat.s@rsu.ac.th
66-2-354-8333
Time Frame
Start Date: 2020-05-18
Estimated Completion Date: 2026-12
Participants
Target number of participants: 250
Treatments
Experimental: Combination therapy with vigabatrin and prednisolone
Vigabatrin (tablet of 500 mg) dose based on weight divided in two times. The protocol for vigabatrin dose is 50 mg/kg/day at Day 1, 100 mg/kg/day at Day 2, and increase to 150 mg/kg/day if seizures still occur after 72 hours after treatment. Vigabatrin will be continued for 3 months, then reduced and completely off within 4 weeks.~Prednisolone (tablet of 5 mg), 40 mg of prednisolone (10 mg oral 4 times a day) for 14 days. Prednisolone will be increased to 60 mg/day (20 mg oral 3 times a day) if seizures still occur at Day 7 or recur within Day 8 - 14. Then, prednisolone will be reduced every 5 day until completely off within 1 month. Total prednisolone duration is 1 month.
Active_comparator: Vigabatrin alone
Vigabatrin (500 mg/tab) dose will be calculated on weight basis divided in two times. The protocol for vigabatrin dose is 50 mg/kg/day at Day 1, 100 mg/kg/day at Day 2, and increase to 150 mg/kg/day if seizures still occur after 72 hours after treatment.~Vigabatrin will be continued for 3 months, then reduced and completely off within 4 weeks.
Sponsors
Leads: Kullasate Sakpichaisakul

This content was sourced from clinicaltrials.gov

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