Addition of Pyridoxine to Prednisolone in Infantile Spasms
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ClinicalTrials.gov Identifier: NCT01828437
Verified April 2013 by Satinder Aneja, Lady Hardinge Medical College. Recruitment status was: Recruiting
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.
Condition or disease
Drug: Pyridoxine plus prednisoloneDrug: Prednisolone
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Ages Eligible for Study:
3 Months to 36 Months (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Age in 3months-3years.
Presence of epileptic spasms (1 or more clusters per day) with EEG evidence of hypsarrythmia or its variants.
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