Intravenous Methylprednisolone Versus Oral Prednisolone for Infantile Spasms
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..
Timeline
- Start
- 2019-04-01
- Primary completion
- 2022-04-30
- Completion
- 2022-10-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Methylprednisolone | Other / unclassified | 30 mg/kg | Intravenous |
| Comparator | Prednisolone | Other / unclassified | 4 mg/kg | Oral |