Intravenous Methylprednisolone Versus Oral Prednisolone for Infantile Spasms

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Brief Title

Intravenous Methylprednisolone Versus Oral Prednisolone for Infantile Spasms

Official Title

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

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..
    

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.
    

Study Phase

Phase 2/Phase 3

Study Type

Interventional


Primary Outcome

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

Secondary Outcome

 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

Condition

Infantile Spasm

Intervention

Intravenous Methylprednisolone

Study Arms / Comparison Groups

 Intervention arm
Description:  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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

128

Start Date

April 1, 2019

Completion Date

October 31, 2022

Primary Completion Date

April 30, 2022

Eligibility Criteria

        Inclusion Criteria:

        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 -

        Exclusion Criteria:

          1. Children with recognized progressive neurological illness will be excluded.

          2. Children with chronic renal, pulmonary, cardiac or hepatic dysfunction

          3. Severe malnutrition (weight for length and height for less than 3 SD for mean as per
             WHO growth charts)

             -
      

Gender

All

Ages

4 Months - 30 Months

Accepts Healthy Volunteers

No

Contacts

Dipti Kapoor, MD, 91-9818426830, [email protected]

Location Countries

India

Location Countries

India

Administrative Informations


NCT ID

NCT03876444

Organization ID

MethylpredIV


Responsible Party

Sponsor-Investigator

Study Sponsor

Suvasini Sharma


Study Sponsor

Dipti Kapoor, MD, Principal Investigator, Lady Hardinge Medical College


Verification Date

November 2019