Prednisolone in Infantile Spasms- High Dose Versus Usual Dose

Infantile Spasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01575639
• Other study ID #: PREDIS
• Status: Completed
• Phase: Phase 3
• First received: April 9, 2012
• Last updated: April 7, 2013
• Start date: February 2012
• Est. completion date: March 2013

Study information

• Verified date: April 2013
• Source: Lady Hardinge Medical College
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Ministry of Health
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: March 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Months to 24 Months

Eligibility

Inclusion Criteria:

• Children aged 3 months to 2 years presenting with epileptic spasms (at least 1 cluster/day) with EEG evidence of hypsarrhythmia or its variants

Exclusion Criteria:

1. Children with active systemic illness

2. Children with evidence of active tuberculosis

3. Severe Acute Malnutrition ad defined by WHO (visible wasting/Mid Upper Arm Circumference < 11 cm/pedal edema/Weight for height < 3 SD)

4. Children with recurrent illness/chronic systemic illness

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infantile Spasms
• Spasm
• Spasms, Infantile
• West Syndrome

Intervention

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

Locations

Country	Name	City	State
India	Lady Hardinge Medical College and Associated Kalawati Saran Children's Hospital	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Lady Hardinge Medical College

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of children who achieved spasm freedom (for at least 48 hours) as per parental reports on day 14 .		14 days	No
Secondary	Proportion of children with adverse effects		14 days	Yes