NCT03876444

Intravenous Methylprednisolone Versus Oral Prednisolone for Infantile Spasms

Intravenous Methylprednisolone Versus High Dose Oral Prednisolone for the Treatment of Infantile Spasms: a Randomized Open-labelled Trial

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 128 (estimated)
• Sponsor: Suvasini Sharma · Other Government
• Sex: All
• Age: 4 Months – 30 Months
• Healthy volunteers: Not accepted

Summary

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..

Detailed description

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.

Conditions

• Infantile Spasm

Interventions

Type	Name	Description
DRUG	Intravenous Methylprednisolone	Intravenous Methylprednisolone will be used in the intervention group
DRUG	Oral Pednisolone	Oral Prednisolone will be used in the Control Group

Timeline

• Start date: 2019-04-01
• Primary completion: 2022-04-30
• Completion: 2022-10-31
• First posted: 2019-03-15
• Last updated: 2019-11-18

Locations

1 site across 1 country: India