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Prednisolone in Infantile Spasms- High Dose Versus Usual Dose

Information source: Lady Hardinge Medical College
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Infantile Spasms; West Syndrome

Intervention: Oral prednisolone (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Lady Hardinge Medical College

Official(s) and/or principal investigator(s):
Satinder Aneja, MD, Principal Investigator, Affiliation: Lady Hardinge Medical College


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

Clinical Details

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

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

Primary outcome: Proportion of children who achieved spasm freedom (for at least 48 hours) as per parental reports on day 14 .

Secondary outcome: Proportion of children with adverse effects


Minimum age: 3 Months. Maximum age: 24 Months. Gender(s): Both.


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

Locations and Contacts

Lady Hardinge Medical College and Associated Kalawati Saran Children's Hospital, New Delhi, Delhi 110001, India
Additional Information

Starting date: February 2012
Last updated: April 7, 2013

Page last updated: August 23, 2015

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