Infantile Spasm Clinical Trial
Official title:
Intravenous Methylprednisolone Versus High Dose Oral Prednisolone for the Treatment of Infantile Spasms: a Randomized Open-labelled Trial
Infantile Spasms (IS) are classically refractory to the usual antiepileptic drugs and often pose a therapeutic challenge. Since, there is associated significant morbidity, much effort has been directed over the past years to evaluate the role of various anticonvulsants in the management of IS. High dose oral prednisolone has been shown to cause early cessation of spasms and resolution of hypsarrythmia on Electroencephalogram. Recently, role of intravenous methylprednislone pulse therapy has been explored as one of the therapeutic modality in IS, in order to avoid the development of side-effects associated with prolonged oral steroid therapy and maintain long-term efficacy.However, there are no studies comparing iv methylprednisolone pulse therapy with high dose oral prednisolone..
Multiple studies have subsequently used higher dose of prednisolone in infantile spasms at
the weight based dosing of 4-8 mg/kg/day with a maximum dose of 60mg/day. The results have
shown high rates of clinical and elecroencephalographic remission with lower relapse
rates.However, a major concern related to corticosteroids, especially in infants and
children, is the possible development of side effects. The most frequent ones are excessive
weight gain, hyperphagia, water retention with edema, cushingoid appearance, hypertension,
behavioral disturbances, increased infection susceptibility, leukopenia, electrolyte
disturbances, hyperglycemia, glycosuria, impaired glucose tolerance, frank diabetes and sleep
disorders. Furthermore, long-term side effects such as hypothalamus-pituitary axis
suppression, psychosis, osteoporosis, nephrocalcinosis, brain atrophy, cataracts and, in
children, growth retardation, have also been reported.
Recently, role of intravenous methylprednislone pulse therapy has been explored as one of the
therapeutic modality in IS, in order to avoid the development of side-effects associated with
prolonged oral steroid therapy and maintain long-term efficacy. There have been few studies
on use of iv pulse methylprednisolone in IS with small sample size, showing to a rapid
improvement in EEG & cessation of spasm in majority of the infants without significant
adverse effects.
Emerging evidence suggests that intravenous pulse methylprednisolone might have superior
efficacy and better safety profile when compared to high dose oral prednisolone in treatment
of IS.
Hence, present study aims at comparing intravenous pulse methylprednisolone versus oral
prednisolone in an open label, RCT for treatment of children with IS.
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