Addition of Pyridoxine to Prednisolone in Infantile Spasms
Status:
Completed
Trial end date:
2014-03-01
Target enrollment:
Participant gender:
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.