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A study about effect of steroid treatment in children with severe epilepsy.

Efficacy of intravenous pulse methyl prednisolone as an add on treatment in epileptic encephalopathy- a randomized controlled study - NICE trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/02/017807
Enrollment
80
Registered
2019-02-25
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: G404- Other generalized epilepsy and epileptic syndromes

Interventions

Intervention1: Intravenous Methyl prednisolone (30 mg/kg) plus AEDs: Pulse IV Methyl prednisolone (30mg/kg) will be given for 5 days/ month for 3 months for children who satisfy the inclusion criteria

Sponsors

NON FUNDED NIMHANS
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Children with age > 6months 2) Diagnosed as epileptic encephalopathy 3) Negative for basic pediatric neurometabolic work 4) No contraindication for steroid treatment 5) Parents who are willing to participate

Exclusion criteria

Exclusion criteria: 1) Parents who are not willing to participate 2) Who have contraindication to steroids (Recurrent infections, primary or secondary immunodeficiency) 3) West syndrome 4) Age 5) Developmental encephalopathies 6) Patients who have had a trial of steroids in the past

Design outcomes

Primary

MeasureTime frame
Assessment of seizure control in patients receiving pulse methylprednisoloneTimepoint: 6months

Secondary

MeasureTime frame
a)To study the phenotypic and EEG features of epileptic encephalopathy and correlate it with the seizure control in children with epileptic encephalopathy b) To study the adverse effects of steroidsTimepoint: 6 months

Countries

India

Contacts

Public ContactSanjib sinha

NIMHANS

sanjib_sinha2004@yahoo.co.in08026995150

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 11, 2026