Prednisolone in Infantile Spasms- High Dose Versus Usual Dose
Status:
Completed
Trial end date:
2013-03-01
Target enrollment:
Participant gender:
Summary
Infantile spasms comprise a difficult to treat type of epilepsy in young children. Hormonal
treatment, i.e. Prednisolone and ACTH are considered the treatment of choice. There is no
consensus on the dosage of Prednisolone required for the treatment of infantile spasms.
Recent data has shown that a high dose (4 mg/kg/day) may be more efficacious than the usual
dose (2 mg/kg/day). However, there are no randomized controlled trials comparing these doses.
A higher steroid dose may also be associated with more side effects. Therefore, this study
was planned to compare the efficacy and tolerability of the high dose versus the usual dose
in children with infantile spasms, in a randomized open-label trial design