Addition of Pyridoxine to Prednisolone in Infantile Spasms

Phase 3

Completed

• Conditions: Infantile Spasms
• Interventions: Drug: Pyridoxine plus prednisolone; Drug: Prednisolone

• Registration Number: NCT01828437
• Lead Sponsor: Lady Hardinge Medical College

Brief Summary

Infantile spasms constitute a unique age specific epilepsy syndrome of infancy, characterized by epileptic spasms often accompanied by neurodevelopmental regression and an EEG finding of hypsarrhythmia. When all 3 components are present, the eponym "West syndrome" is commonly used. West syndrome is a catastrophic epileptic encephalopathy. It does not respond well to standard anti-epileptic drugs. Hormonal therapy is the mainstay in the treatment of infantile spasms. This includes adreno-cortico trophic hormone (ACTH) and oral steroids. Variable dose of prednisolone used in the treatment. Oral prednisolone used in usual dose (2mg/kg) has been shown to be less effective as compared to ACTH. High dose prednisolone (4mg/kg) has been used in the treatment of infantile spasms, which has been shown to be as effective as ACTH. Pyridoxine has been used as first line treatment in Japan, however there is paucity of data on the efficacy of combination of pyridoxine with hormonal therapy. There are no studies comparing add on pyridoxine with high prednisolone versus high dose prednisolone alone in the treatment of infantile spasms. Therefore the study has been planned to see whether the addition of pyridoxine with high dose prednisolone in the treatment of infantile spasms improves the efficacy in terms of spasm cessation.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2013-04-07
• Study First Submitted QC: 2013-04-09
• Study First Posted: 2013-04-10
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-12
• Last Update Posted: 2019-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

1. Age in 3months-3years.

2. Presence of epileptic spasms (1 or more clusters per day) with EEG evidence of hypsarrythmia 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 (standard deviation scores below median weight for height)

4. Children with recurrent illness/chronic systemic illness

5. Prior treatment of pyridoxine, steroid, or ACTH.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pyridoxine plus prednisolone	Pyridoxine plus prednisolone	allocated patients receive pyridoxine (30 mg/kg/day) in addition to prednisolone
Prednisolone	Prednisolone	allocated patients receive prednisolone alone

Primary Outcome Measures

Name	Time	Method
Proportion of children who achieved complete cessation spasm for at least 48 hours as per parental reports at the end of 2 weeks in both the groups.	2 weeks	Proportion of children who achieved complete cessation spasm for at least 48 hours as per parental reports at the end of 2 weeks in both the groups.

Secondary Outcome Measures

Name	Time	Method
• Proportion of children who achieved more than 50 % reduction of clinical spasms as per parental reports at the end of 2 weeks	2 weeks

Trial Locations

Locations (1)

Lady Hardinge Medical College; 🇮🇳 New Delhi, India