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Intravenous Methylprednisolone Versus Oral Prednisolone for Infantile Spasms

NCT03876444 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2019-11-18

No results posted yet for this study

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..

Conditions

  • Infantile Spasm

Interventions

DRUG

Intravenous Methylprednisolone

Intravenous Methylprednisolone will be used in the intervention group

DRUG

Oral Pednisolone

Oral Prednisolone will be used in the Control Group

Sponsors & Collaborators

  • Suvasini Sharma

    lead OTHER_GOV

Principal Investigators

  • Dipti Kapoor, MD · Lady Hardinge Medical College

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Months
Max Age
30 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-01
Primary Completion
2022-04-30
Completion
2022-10-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03876444 on ClinicalTrials.gov