Prednisolone in Infantile Spasms- High Dose Versus Usual Dose

Lady Hardinge Medical College

Status and phase: Completed; Phase 3

Conditions: Infantile Spasms; West Syndrome

Treatments: Drug: Oral prednisolone

Study type: Interventional

Funder types: Other

Identifiers

NCT01575639

PREDIS

Details and patient eligibility

About

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

Enrollment: 63 patients

Sex: All

Ages: 3 to 24 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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63 participants in 2 patient groups

High dose

Experimental group

Description:

Oral Prednisolone will be given at dose of 4 mg/kg/day for 14 days

Treatment:

Drug: Oral prednisolone

Usual dose

Active Comparator group

Description:

Oral prednisolone will be given at dose of 2 mg/kg/day for 14 days

Treatment:

Drug: Oral prednisolone