Addition of Pyridoxine to Prednisolone in Infantile Spasms

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2014-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Infantile Spasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pyridoxine plus prednisolone

allocated patients receive pyridoxine (30 mg/kg/day) in addition to prednisolone

Group Type EXPERIMENTAL

Pyridoxine plus prednisolone

Intervention Type DRUG

Prednisolone

allocated patients receive prednisolone alone

Group Type ACTIVE_COMPARATOR

Prednisolone

Intervention Type DRUG

Interventions

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Pyridoxine plus prednisolone

Intervention Type DRUG

Prednisolone

Intervention Type DRUG

Eligibility Criteria

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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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Minimum Eligible Age

3 Months

Maximum Eligible Age

36 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No