Efficacy and Safety of corticosteroids and vigabatrin plus corticosteroids in infantile spasm
Not Applicable
Recruiting
- Conditions
- Infantile spasm.Epileptic spasms, not intractable, without status epilepticusG40.822
- Registration Number
- IRCT20200414047072N2
- Lead Sponsor
- The Children's Hospital & the Institute of Child Health, Multan.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 320
Inclusion Criteria
Signed informed consent from parents/guardians
Children aged one to 12 months
Both genders with clinical diagnosis of infantile spasm made according to international league against epilepsy plus hypsarrhythmia on EEG (EEG records were graded using the Burden of Amplitudes and Epileptiform Discharges (BASED) scoring system
Exclusion Criteria
Infantile spasm due to tuberous sclerosis
Previous treatment with steroids or vigabatrin
Contraindication to steroids/vigabatrin (fever, active infection and hypertension).
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie corticosteroid and vigabatrin efficacy in infantile spasm treatment?
How does combination therapy with vigabatrin plus corticosteroids compare to monotherapy in infantile spasm management?
Which biomarkers correlate with response to corticosteroid-based treatments in G40.822 epileptic spasms?
What are the potential adverse events associated with corticosteroid and vigabatrin combination therapy in infants?
Are there alternative drug combinations to vigabatrin plus corticosteroids for non-intractable infantile spasm treatment?