Addition of Pyridoxine to Prednisolone in Infantile Spasms

Study Overview
=================
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.

Official Title
-----------------
Addition of Pyridoxine to Prednisolone in the Treatment of Infantile Spasms: A Randomized Controlled Trial

Conditions
-----------------
Infantile Spasms

Intervention / Treatment
-----------------
* Drug: Pyridoxine plus prednisolone
* Drug: Prednisolone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age in 3months-3years. Presence of epileptic spasms (1 or more clusters per day) with EEG evidence of hypsarrythmia or its variants. - Exclusion Criteria: Children with active systemic illness Children with evidence of active tuberculosis Severe Acute Malnutrition (standard deviation scores below median weight for height) Children with recurrent illness/chronic systemic illness Prior treatment of pyridoxine, steroid, or ACTH. -

Ages Eligible for Study
-----------------
Minimum Age: 3 Months
Maximum Age: 36 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pyridoxine plus prednisolone<br>allocated patients receive pyridoxine (30 mg/kg/day) in addition to prednisolone | Drug: Pyridoxine plus prednisolone<br> <br> |
| Active Comparator: Prednisolone<br>allocated patients receive prednisolone alone | Drug: Prednisolone<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • Proportion of children who achieved more than 50 % reduction of clinical spasms as per parental reports at the end of 2 weeks |  | 2 weeks |