NCT01575639

Prednisolone in Infantile Spasms- High Dose Versus Usual Dose

Randomized Trial of High Dose (4mg/kg) Versus Usual Dose (2mg/kg) Oral Prednisolone in the Treatment of Infantile Spasms.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Lady Hardinge Medical College · Other Government
• Sex: All
• Age: 3 Months – 24 Months
• Healthy volunteers: Not accepted

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

Conditions

• Infantile Spasms
• West Syndrome

Interventions

Type	Name	Description
DRUG	Oral prednisolone	Dose will be different in the two groups. the high dose group will receive 4 mg/kg/day. The usual dose group will receive 2 mg/kg/day

Timeline

• Start date: 2012-02-01
• Primary completion: 2013-02-01
• Completion: 2013-03-01
• First posted: 2012-04-11
• Last updated: 2013-04-09

Locations

1 site across 1 country: India