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Prednisolone in Infantile Spasms- High Dose Versus Usual Dose

Primary Purpose

Infantile Spasms, West Syndrome

Status

Completed

Phase

Phase 3

Locations

India

Study Type

Interventional

Intervention

Oral prednisolone

About this trial

This is an interventional treatment trial for Infantile Spasms

Eligibility Criteria

3 Months - 24 Months (Child)All SexesDoes not accept healthy volunteers

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:

Children with active systemic illness
Children with evidence of active tuberculosis
Severe Acute Malnutrition ad defined by WHO (visible wasting/Mid Upper Arm Circumference < 11 cm/pedal edema/Weight for height < 3 SD)
Children with recurrent illness/chronic systemic illness

Sites / Locations

Lady Hardinge Medical College and Associated Kalawati Saran Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High dose

Usual dose

Arm Description

Oral Prednisolone will be given at dose of 4 mg/kg/day for 14 days

Oral prednisolone will be given at dose of 2 mg/kg/day for 14 days

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Proportion of children with adverse effects

Full Information

NCT ID

NCT01575639

First Posted

April 9, 2012

Last Updated

April 7, 2013

Sponsor

Lady Hardinge Medical College

1. Study Identification

Unique Protocol Identification Number

NCT01575639

Brief Title

Prednisolone in Infantile Spasms- High Dose Versus Usual Dose

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2013

Overall Recruitment Status

Completed

Study Start Date

February 2012 (undefined)

Primary Completion Date

February 2013 (Actual)

Study Completion Date

March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Lady Hardinge Medical College

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infantile Spasms, West Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

63 (Actual)

8. Arms, Groups, and Interventions

Arm Title

High dose

Arm Type

Experimental

Arm Description

Oral Prednisolone will be given at dose of 4 mg/kg/day for 14 days

Arm Title

Usual dose

Arm Type

Active Comparator

Arm Description

Oral prednisolone will be given at dose of 2 mg/kg/day for 14 days

Intervention Type

Drug

Intervention Name(s)

Oral prednisolone

Intervention Description

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

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

Proportion of children with adverse effects

Time Frame

14 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Months

Maximum Age & Unit of Time

24 Months

Accepts Healthy Volunteers

Eligibility 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: Children with active systemic illness Children with evidence of active tuberculosis Severe Acute Malnutrition ad defined by WHO (visible wasting/Mid Upper Arm Circumference < 11 cm/pedal edema/Weight for height < 3 SD) Children with recurrent illness/chronic systemic illness

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Satinder Aneja, MD

Organizational Affiliation

Lady Hardinge Medical College

Official's Role

Principal Investigator

Facility Information:

Facility Name

Lady Hardinge Medical College and Associated Kalawati Saran Children's Hospital

City

New Delhi

State/Province

Delhi

ZIP/Postal Code

110001

Country

India

12. IPD Sharing Statement

Citations:

PubMed Identifier

25048310

Citation

Chellamuthu P, Sharma S, Jain P, Kaushik JS, Seth A, Aneja S. High dose (4 mg/kg/day) versus usual dose (2 mg/kg/day) oral prednisolone for treatment of infantile spasms: an open-label, randomized controlled trial. Epilepsy Res. 2014 Oct;108(8):1378-84. doi: 10.1016/j.eplepsyres.2014.06.019. Epub 2014 Jul 5.

Results Reference

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Prednisolone in Infantile Spasms- High Dose Versus Usual Dose

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