This prospective observational study was conducted at a tertiary care hospital in North India from January 2019 to October 2020. Children with WS resistant to standard
therapy were enrolled within 7 d of initiation of
nitrazepam and prospectively followed-up for cessation of
spasms and adverse events.
RESULTS: Forty-one children with resistant WS initiated on
nitrazepam therapy were evaluated. The median age at onset of
spasms was 6 mo (Q1, Q3: 4, 8). There was a preponderance of male gender (71%) and structural causes (78%). More than half of the enrolled children had failed four or more antiseizure medications (ASM) for epileptic
spasms. The study participants had a long lead-
time-to-treatment (LTTT) for the initial standard
therapy (median: 2 mo; Q1, Q3: 1, 5) and
nitrazepam (median: 11 mo; Q1, Q3: 8, 16).
Nitrazepam was instituted as monotherapy in 7 (17%) children and as an adjunct in the rest. Twenty-one (51%) children achieved persistent cessation of epileptic
spasms. However, the electroclinical response was observed in 17 (42%) children. Drowsiness,
sialorrhea, and decreased appetite were the most commonly observed adverse events. Most adverse events were mild to moderate in severity and did not require
dose reduction or change of medication. There was no significant difference between the responders and nonresponders in terms of LTTT, age at onset, or etiology.
CONCLUSIONS: