Infantile Spasm Clinical Trial
— MPIVOfficial title:
Intravenous Methylprednisolone Versus High Dose Oral Prednisolone for the Treatment of Infantile Spasms: a Randomized Open-labelled Trial
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..
Status | Recruiting |
Enrollment | 128 |
Est. completion date | October 31, 2022 |
Est. primary completion date | April 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 4 Months to 30 Months |
Eligibility |
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) - |
Country | Name | City | State |
---|---|---|---|
India | Lady Hardinge Medical College | New Delhi | Delhi |
Lead Sponsor | Collaborator |
---|---|
Suvasini Sharma |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | 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 | |
Secondary | 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. | 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 | |
Secondary | Description and proportion of the adverse effects of methylprednisolone in the experimental group | Description and proportion of the adverse effects of methylprednisolone in the experimental group | 6 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
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