Health Condition 1: G404- Other generalized epilepsy and epileptic syndromes
Conditions
Interventions
Intervention1: Oral nitrazepam: Oral nitrazepam (5 mg) will be initiated at a dose of 0.5-1 mg/kg/day in 2 divided doses. The subsequent dose escalation will be every 6 days of 0.5/kg/day to reach a m
Sponsors
Postgraduate Institute of Medical Education and Research
Eligibility
Inclusion criteria
Inclusion criteria: 1. Children should be fulfilling the diagnostic criteria of IESS (ILAE 2022) 2. Male or female, age range 6-30 months at enrollment. 3. Failed to achieve the cessation of epileptic spasms on two of three first-line therapies (ACTH, oral steroids, vigabatrin therapy) or failure to achieve the cessation of epileptic spasms on one of three first-line therapies (ACTH, oral steroids, vigabatrin therapy) when other two options were either not feasible or considered not suitable by treating neurologists or declined by parents. 4. Within six weeks of failing on hormonal therapy and/or vigabatrin therapy
Exclusion criteria
Exclusion criteria: 1. Parents decline to participate in the study. 2. Known contraindications for topiramate or nitrazepam (glaucoma, renal stone, liver disease) 3. Known allergy to topiramate or nitrazepam. 4. Co-intervention with another anti-seizure medication (ASM) in the last two weeks 5. Proven or suspected cases of neurometabolic or neurodegenerative disorder 6. Known history of aspiration pneumonia in last 3 months 7. Weight below 3 kg
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complete cessation of epileptic spasmsTimepoint: 6-10 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Electroclinical responseTimepoint: 6-10 weeks;Time to achieve cessation of spasmsTimepoint: Day 1-week 10;50% reduction of epileptic spasmsTimepoint: 6-10 weeks;Heart rate variabilityTimepoint: 10 weeks;QUALIN ScoreTimepoint: 10 weeks;Treatment emergent adverse eventsTimepoint: Day 1-10 weeks;Tolerability (retention rates for antiseizure medication)Timepoint: 10 weeks;Resolution of hypsarrhythmiaTimepoint: 6 weeks | — |
Countries
India
Contacts
Public ContactJitendra Kumar Sahu
Advanced Pediatric Center, Postgraduate Institute of Medical Education and Research
Outcome results
None listed