A clinical trial to compare two different doses of Prednisolone in the management of children with West syndrome

High dose versus very high dose prednisolone in the management of newly diagnosed children with West syndrome: An open labelled randomized trial.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/09/036739

Enrollment

Registered

2021-09-22

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G408- Other epilepsy and recurrent seizures

Interventions

Intervention1: Fourteen days high dose Prednisolone therapy: High dose Prednisolone(4mg/kg /day) for fourteen days, maximum daily dose being 60mg Control Intervention1: Fourteen days very high dose Pr

Eligibility

Inclusion criteria

Inclusion criteria: Newly diagnosed children aged 3-36 months with West syndrome

Exclusion criteria

Exclusion criteria: 1.children with recognised progressive neurological illness. 2.children with 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. 4.Those screened positive for mantoux test( >10mm).

Design outcomes

Primary

Measure	Time frame
Electroclinical remission at 2 weeks of treatmentTimepoint: 2 weeks	—

Secondary

Measure	Time frame
1-50% reduction in spasms at 2 weeks of treatment 2-safety of high dose and very high dose Prednisolone in terms of proportion of children with parent reported side effects.Timepoint: 2 weeks	—

Countries

India

Contacts

Public ContactPooja dagar

Pandit B.D. Sharma PGIMS Rohtak

jskaushik2010@gmail.com9871174069

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026