Intravenous Methylprednisolone Versus Oral Prednisolone for Infantile Spasms

NCT03876444 | Unknown Phase 2

• 1 other identifier: MethylpredIV
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Hypsarrythmia; Methylprednisolone; Prednisolone

Outcome Measures

Primary Outcomes (1)

• Proportion of children who achieved spasm freedom as per parental reports in both the groups

  The proportion of children who achieve spasm freedom defined as no witnessed spasms on and between day 14 and day 42 as per parental reports will be evaluated in the both the groups

  6 weeks

Secondary Outcomes (3)

• Number of days after initiation of trial treatment on which spasms were not seen and after which response was maintained until 6 weeks (day 42) of treatment in both the groups

  6 weeks

• Proportion of children who achieve resolution of hypsarrhythmia on electro encephalogram at 2 weeks (in all cases) and at 6 weeks (for cases with sustained clinical response) in both the groups.

  6 weeks

• Description and proportion of the adverse effects of methylprednisolone in the experimental group

  6 weeks

Study Arms (2)

Intervention arm

EXPERIMENTAL

Pulse intravenous methylprednisolone (30 mg / kg for 3 days) followed by 1-week taper of oral prednisolone Day 1-3 Intravenous Methylprednisolone in dose of 30 mg/kg/day Day 4-6 Oral Prednisolone in dose of 2mg/kg/day Day 7-10 Oral Prednisolone in dose of 1mg/kg/day

Drug: Intravenous Methylprednisolone

Control

ACTIVE COMPARATOR

Oral prednisolone (4 mg/kg/day) for 2 weeks followed by tapering over 2 weeks Day 1-14 (2 weeks): dose 4mg/kg/day Day 15-21 (1 weeks): 2mg/kg/day Day 22-28 (1 weeks): 1mg/kg/day

Drug: Oral Pednisolone

Interventions

Intravenous Methylprednisolone DRUG

Intravenous Methylprednisolone will be used in the intervention group

Intervention arm

Oral Pednisolone DRUG

Oral Prednisolone will be used in the Control Group

Control

Eligibility Criteria

• Age: 4 Months - 30 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Newly diagnosed patients aged 4 - 30 months with epileptic spasms in clusters with electroencephalographic evidence of hypsarrhythmia or its variants with or without developmental delay -

You may not qualify if:

• Children with recognized progressive neurological illness will be excluded.
• Children with chronic renal, pulmonary, cardiac or hepatic dysfunction
• Severe malnutrition (weight for length and height for less than 3 SD for mean as per WHO growth charts)

Sponsors & Collaborators

• Suvasini Sharma: lead

Study Sites (1)

Lady Hardinge Medical College

New Delhi, National Capital Territory of Delhi, 110001, India

RECRUITING

Related Publications (1)

• Kapoor D, Sharma S, Garg D, Samaddar S, Panda I, Patra B, Mukherjee SB, Pemde HK. Intravenous Methylprednisolone Versus Oral Prednisolone for West Syndrome: A Randomized Open-Label Trial. Indian J Pediatr. 2021 Aug;88(8):778-784. doi: 10.1007/s12098-020-03630-3. Epub 2021 Feb 11.

  PMID: 33575989 DERIVED

MeSH Terms

Conditions

Spasms, Infantile

Condition Hierarchy (Ancestors)

Epilepsy, Generalized; Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epileptic Syndromes

Study Officials

• Dipti Kapoor, MD

  Lady Hardinge Medical College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dipti Kapoor, MD

CONTACT

91-9818426830; diptikumar81@yahoo.co.in

Suvasini Sharma, MD, DM

CONTACT

91-9910234344; sharma.suvasini@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: Open label Randomized Control Trial

Study Record Dates

• First Submitted: March 12, 2019
• First Posted: March 15, 2019
• Study Start: April 1, 2019
• Primary Completion: April 30, 2022
• Study Completion: October 31, 2022
• Last Updated: November 18, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)