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
|Condition or disease||Intervention/treatment||Phase|
|Infantile Spasm||Drug: Intravenous Methylprednisolone Drug: Oral Pednisolone||Phase 2 Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||128 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Open label Randomized Control Trial|
|Masking:||None (Open Label)|
|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|
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
- 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
- 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
- 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.
- 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
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
|Contact: Dipti Kapoor, MDfirstname.lastname@example.org|
|Contact: Suvasini Sharma, MD, DMemail@example.com|
|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|
|Principal Investigator:||Dipti Kapoor, MD||Lady Hardinge Medical College|