Prednisolone in Infantile Spasms- High Dose Versus Usual Dose

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01575639
• Date of registration: 09/04/2012
• Prospective Registration: No
• Primary sponsor: Lady Hardinge Medical College
• Public title: Prednisolone in Infantile Spasms- High Dose Versus Usual Dose
• Scientific title: Randomized Trial of High Dose (4mg/kg) Versus Usual Dose (2mg/kg) Oral Prednisolone in the Treatment of Infantile Spasms.
• Date of first enrolment: February 2012
• Target sample size: 63
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01575639
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

India

Contacts

• Name: Satinder Aneja, MD
• Affiliation: Lady Hardinge Medical College

Key inclusion & exclusion criteria

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



Age minimum: 3 Months
Age maximum: 24 Months
Gender: Both

Health Condition(s) or Problem(s) studied

Infantile Spasms

West Syndrome

Intervention(s)

Drug: Oral prednisolone

Primary Outcome(s)

Proportion of children who achieved spasm freedom (for at least 48 hours) as per parental reports on day 14 . [Time Frame: 14 days]

Secondary Outcome(s)

Proportion of children with adverse effects [Time Frame: 14 days]

Secondary ID(s)

PREDIS

Source(s) of Monetary Support

Please refer to primary and secondary sponsors