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Nitrazepam for refractory infantile spasms and the Lennox-Gastaut syndrome
1University of California San Diego, La Jolla, 92093-0812, USA.
Insights
Nitrazepam effectively treated medically refractory infantile spasms and Lennox-Gastaut syndrome in young children. This study found a 25% response rate with modest side effects, offering a new option for pediatric epilepsy.
Area of Science:
- Pediatric Neurology
- Clinical Pharmacology
Background:
- Infantile spasms and Lennox-Gastaut syndrome are age-specific pediatric epileptic syndromes.
- These conditions often present as medically resistant seizures in childhood.
Purpose of the Study:
- To evaluate the efficacy and safety of the investigational benzodiazepine nitrazepam.
- To assess nitrazepam's response rate in children with refractory infantile spasms or Lennox-Gastaut syndrome.
Main Methods:
- An open-label study involving 20 children (4-28 months) with refractory epilepsy.
- Nitrazepam dosage ranged from 0.5 to 3.5 mg/kg/day, with a median of 1.5 mg/kg/day.
- Seizure response and side effects were monitored.
Main Results:
- A 25% overall response rate was observed (5 complete, 7 partial responses).
- Median response duration was 9 months for infantile spasms and 14 months for Lennox-Gastaut syndrome.
- Common side effects included oral secretions pooling and sedation; no serious adverse events were reported.
Conclusions:
- Nitrazepam demonstrated efficacy as an anticonvulsant in this pediatric cohort.
- The drug showed a favorable safety profile with modest side effects.
- Nitrazepam represents a potential treatment option for medically refractory infantile spasms and Lennox-Gastaut syndrome.
Abstract:
Infantile spasms and the Lennox-Gastaut syndrome are considered to be age-specific pediatric epileptic syndromes and together constitute a significant percentage of medically resistant seizures in childhood. Twenty children, ages 4 to 28 months (median, 12 months), with medically refractory infantile spasms or the Lennox-Gastaut syndrome, were treated with the investigational benzodiazepine nitrazepam in an open-label study. Daily dosage of nitrazepam ranged from 0.5 to 3.5 mg/kg, with a median dosage of 1.5 mg/kg, divided into two doses per day. Side effects included pooling of oral secretions (12 children) and sedation (six children); however, no serious side effects were seen. Responses to nitrazepam were as follows: five complete responses (cessation of all seizures), seven partial responses (greater than 50% reduction of seizures), and eight with no response. Median duration of response was 9 months (range, 4 to 16 months) in children with infantile spasms and 14 months (range, 8 to 26 months) in children with the Lennox-Gastaut syndrome. Nitrazepam is an effective anticonvulsant in this small cohort of children with medically refractory infantile spasms and the Lennox-Gastaut syndrome, resulting in a 25% response rate and only modest side effects.