Diazepam Nasal Spray May Space Out Seizure Clusters

What was studied

This study looked at whether the time between seizure clusters changed over time in young children with epilepsy who used diazepam nasal spray as a rescue medicine. The children were 2 to 5 years old and were part of an open-label Phase 1/2a trial, meaning everyone knew they were getting the study medicine.

The trial included 36 children. Researchers gave doses of 5, 10, or 15 mg based on body weight (0.5 mg/kg) and followed the children during a 180-day safety period, with an optional extension. In this later analysis, the researchers looked back at the number of days between seizure clusters during consecutive 90-day periods.

What they found

Among the 36 children enrolled, 22 had at least one measurable interval between seizure clusters. Across the study, 315 intervals were recorded. The average time between seizure clusters increased over time: it was 25.2 days in the first 90-day period and 51.9 days in the third 90-day period. In a smaller group of 7 children who kept using the medicine and had data in each period, the average interval also increased, from 22.1 days to 27.7 days. The authors say this is in line with an earlier analysis in older patients and suggest a possible longer-term treatment effect beyond acute use, but this analysis does not establish proof.

Limits of the evidence

This was a small study, especially by the third time period, where only 8 children had data, and the consistent subgroup had only 7 children. The analysis was post hoc, meaning it was done after the main study and was not the original main goal. The study was open-label and did not include a comparison group, so it cannot show from this analysis alone that diazepam nasal spray caused the longer time between seizure clusters. The results may not apply to all children with epilepsy.

For families and caregivers

For families, this study suggests that in some young children who use diazepam nasal spray for seizure clusters, the clusters may happen farther apart over time. Still, this study does not prove the spray prevents future clusters, and the results are based on a small number of children. It is best viewed as early evidence that needs confirmation in larger studies.

What to watch next

Larger studies, including studies with a comparison group, could help clarify whether changes in time between seizure clusters are related to diazepam nasal spray use in young children.

Terms in this summary

seizure cluster

An intermittent increase in seizure activity that differs from a person's usual seizure pattern.

diazepam nasal spray

A rescue medicine sprayed into the nose that is approved to treat seizure clusters.

benzodiazepine

A type of medicine used in immediate-use seizure medications, also called rescue therapies.

open-label trial

A study where patients and researchers know which treatment is being given.

post hoc analysis

An analysis planned after the study was already done, using existing data.

pharmacokinetics

The study of how a drug moves through the body, such as how it is absorbed and cleared.

SEIVAL

The number of days between one seizure cluster and the next.