Prednisolone in Infantile Spasms- High Dose Versus Usual Dose

Phase 3

Completed

• Conditions: Infantile Spasms; West Syndrome
• Interventions: Drug: Oral prednisolone

• Registration Number: NCT01575639
• Lead Sponsor: Lady Hardinge Medical College

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-04-09
• Study First Submitted QC: 2012-04-10
• Study First Posted: 2012-04-11
• Primary Completion: 2013-02
• Study Completion: 2013-03
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-07
• Last Update Posted: 2013-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High dose	Oral prednisolone	Oral Prednisolone will be given at dose of 4 mg/kg/day for 14 days
Usual dose	Oral prednisolone	Oral prednisolone will be given at dose of 2 mg/kg/day for 14 days

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Proportion of children with adverse effects	14 days

Trial Locations

Locations (1)

Lady Hardinge Medical College and Associated Kalawati Saran Children's Hospital; 🇮🇳 New Delhi, Delhi, India