Comparing Vigabatrin with High Dose Prednisolone Combination to Vigabatrin Alone for Treating Infantile Spasms in Babies 2 to 14 Months Old

What this Trial Is About

Infantile spasms IS are seizures linked to a serious brain condition in infants, characterized by specific seizure patterns and developmental delays. Researchers are comparing two treatments to see which better stops spasms and improves brain activity a combination of vigabatrin with high dose prednisolone versus vigabatrin alone. This trial addresses challenges in treatment availability, especially where ACTH is not accessible, like in Thailand. The study involves two groups. One group receives vigabatrin tablets in doses adjusted by weight, gradually increasing if seizures persist, continued for three months before tapering off over four weeks. The other group receives the same vigabatrin dosing plus high dose prednisolone tablets for one month, starting at 40 mg daily and increasing to 60 mg if needed, then tapered off. The treatments are given orally, and the study compares their effectiveness in stopping spasms. Participants are infants aged 2 to 14 months diagnosed with infantile spasms. Researchers will monitor seizure cessation between days 14 and 42 after treatment starts and assess brain wave activity with EEG at specific intervals. They will also track relapse, adverse reactions, and long-term epilepsy outcomes up to 18 months of age. Caregivers and medical staff will be involved throughout the study duration, which includes follow-up assessments to measure treatment responses and safety.

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