Prednisolone in Infantile Spasms- High Dose Versus Usual Dose
Information source: Lady Hardinge Medical College
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Infantile Spasms; West Syndrome
Intervention: Oral prednisolone (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Lady Hardinge Medical College Official(s) and/or principal investigator(s): Satinder Aneja, MD, Principal Investigator, Affiliation: Lady Hardinge Medical College
Summary
Infantile spasms comprise a difficult to treat type of epilepsy in young children. Hormonal
treatment, i. e. Prednisolone and ACTH are considered the treatment of choice. There is no
consensus on the dosage of Prednisolone required for the treatment of infantile spasms.
Recent data has shown that a high dose (4 mg/kg/day) may be more efficacious than the usual
dose (2 mg/kg/day). However, there are no randomized controlled trials comparing these
doses. A higher steroid dose may also be associated with more side effects. Therefore, this
study was planned to compare the efficacy and tolerability of the high dose versus the usual
dose in children with infantile spasms, in a randomized open-label trial design
Clinical Details
Official title: Randomized Trial of High Dose (4mg/kg) Versus Usual Dose (2mg/kg) Oral Prednisolone in the Treatment of Infantile Spasms.
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Proportion of children who achieved spasm freedom (for at least 48 hours) as per parental reports on day 14 .
Secondary outcome: Proportion of children with adverse effects
Eligibility
Minimum age: 3 Months.
Maximum age: 24 Months.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Children aged 3 months to 2 years presenting with epileptic spasms (at least 1
cluster/day) with EEG evidence of hypsarrhythmia or its variants
Exclusion Criteria:
1. Children with active systemic illness
2. Children with evidence of active tuberculosis
3. Severe Acute Malnutrition ad defined by WHO (visible wasting/Mid Upper Arm
Circumference < 11 cm/pedal edema/Weight for height < 3 SD)
4. Children with recurrent illness/chronic systemic illness
Locations and Contacts
Lady Hardinge Medical College and Associated Kalawati Saran Children's Hospital, New Delhi, Delhi 110001, India
Additional Information
Starting date: February 2012
Last updated: April 7, 2013
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