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Trial record 2 of 4 for:    "West Syndrome" | "Prednisolone hemisuccinate"

Intravenous Methylprednisolone Versus Oral Prednisolone for Infantile Spasms (MPIV)

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ClinicalTrials.gov Identifier: NCT03876444
Recruitment Status : Not yet recruiting
First Posted : March 15, 2019
Last Update Posted : March 15, 2019
Sponsor:
Information provided by (Responsible Party):
Suvasini Sharma, Lady Hardinge Medical College

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..

Condition or disease Intervention/treatment Phase
Infantile Spasm Drug: Intravenous Methylprednisolone Drug: Oral Pednisolone Phase 2 Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Open label Randomized Control Trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intravenous Methylprednisolone Versus High Dose Oral Prednisolone for the Treatment of Infantile Spasms: a Randomized Open-labelled Trial
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : April 30, 2022
Estimated Study Completion Date : October 31, 2022


Arm Intervention/treatment
Experimental: Intervention arm
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
Intravenous Methylprednisolone will be used in the intervention group

Active Comparator: Control
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
Oral Prednisolone will be used in the Control Group




Primary Outcome Measures :
  1. Proportion of children who achieved spasm freedom as per parental reports in both the groups [ Time Frame: 6 weeks ]
    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


Secondary Outcome Measures :
  1. 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 [ Time Frame: 6 weeks ]
    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

  2. 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. [ Time Frame: 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.

  3. Description and proportion of the adverse effects of methylprednisolone in the experimental group [ Time Frame: 6 weeks ]
    Description and proportion of the adverse effects of methylprednisolone in the experimental group



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Ages Eligible for Study:   4 Months to 30 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

    -


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03876444


Contacts
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Contact: Dipti Kapoor, MD 91-9818426830 diptikumar81@yahoo.co.in
Contact: Suvasini Sharma, MD, DM 91-9910234344 sharma.suvasini@gmail.com

Locations
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India
Lady Hardinge Medical College Not yet recruiting
New Delhi, Delhi, India, 110001
Principal Investigator: Dipti Kapoor, MD         
Sub-Investigator: Suvasini Sharma, MD,DM         
Sub-Investigator: Sharmila B Mukherjee, MD         
Sub-Investigator: Bijoy Patra, MD         
Sub-Investigator: Harish Pemde, MD         
Sponsors and Collaborators
Suvasini Sharma
Investigators
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Principal Investigator: Dipti Kapoor, MD Lady Hardinge Medical College

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Responsible Party: Suvasini Sharma, Associate Professor, Lady Hardinge Medical College
ClinicalTrials.gov Identifier: NCT03876444     History of Changes
Other Study ID Numbers: MethylpredIV
First Posted: March 15, 2019    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Suvasini Sharma, Lady Hardinge Medical College:
Hypsarrythmia
Methylprednisolone
Prednisolone
Additional relevant MeSH terms:
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Prednisolone
Methylprednisolone Acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Spasm
Spasms, Infantile
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Epilepsy, Generalized
Epilepsy
Brain Diseases
Central Nervous System Diseases
Epileptic Syndromes
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents