Infantile Spasms Clinical Trial
Official title:
Randomized Trial of High Dose (4mg/kg) Versus Usual Dose (2mg/kg) Oral Prednisolone in the Treatment of Infantile Spasms.
Verified date | April 2013 |
Source | Lady Hardinge Medical College |
Contact | n/a |
Is FDA regulated | No |
Health authority | India: Ministry of Health |
Study type | Interventional |
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
Status | Completed |
Enrollment | 63 |
Est. completion date | March 2013 |
Est. primary completion date | February 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 3 Months to 24 Months |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
India | Lady Hardinge Medical College and Associated Kalawati Saran Children's Hospital | New Delhi | Delhi |
Lead Sponsor | Collaborator |
---|---|
Lady Hardinge Medical College |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of children who achieved spasm freedom (for at least 48 hours) as per parental reports on day 14 . | 14 days | No | |
Secondary | Proportion of children with adverse effects | 14 days | Yes |
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