Seizure prophylaxis versus epilepsy prevention after acquired brain injury: a cross-sectional clinicaltrials.gov...

Seizures after acquired brain injury pose distinct therapeutic questions: early seizure prophylaxis, treatment of acute symptomatic seizures, and late epilepsy prevention. These endpoints are often conflated, although early seizure suppression does not establish disease-modifying antiepileptogenesis, these end points are often confused.

We performed a cross-sectional analysis of ClinicalTrials.gov records that were first posted from January 1, 2000, to June 18, 2026. Records retrieved through four disease-specific seizure-related searches were exported from the ClinicalTrials.gov web interface, deduplicated by NCT number, and adjudicated into a primary seizure-management or sensitivity/monitoring cohort. A purposively selected validation set of 269 potentially eligible or difficult-to-classify records underwent independent post-review classification by 2 reviewers who were blinded to each other's responses. A prespecified secondary subset comprised completed primary-cohort trials evaluating pharmacologic interventions.

The searches yielded 1,054 exported records and 878 unique records after deduplication. Final adjudication retained 85 primary cohort studies and 39 sensitivity/monitoring records. Brain tumor/neurosurgery (27/85, 31.8%) and traumatic brain injury (TBI) (23/85, 27.1%) predominated, whereas intracerebral hemorrhage and subarachnoid hemorrhage each had only 3 trials. Among the 44 completed or discontinued trials, 17 (38.6%) were discontinued. Among 26 completed trials eligible for results-reporting assessment, 11 (42.3%) had posted results, of which 10 (90.9%) were interventional drug trials. Only 3 of 15 completed pharmacologic trials had a late-prevention aim. Reviewer agreement ranged from 85.1% to 90.3%, with unweighted Cohen kappa values of 0.776-0.825.

The seizure management pipeline after acquired brain injury registered on ClinicalTrials.gov is concentrated in brain tumor/neurosurgery and TBI, with sparse representation of hemorrhagic stroke and few completed pharmacologic trials targeting late epilepsy prevention. The registry findings support a clearer separation of the objectives of acute seizure prophylaxis, treatment of acute symptomatic seizures, and late epilepsy prevention. The etiology-specific design recommendations are presented as an author-proposed framework rather than empirical effectiveness conclusions.

Not applicable.