Profilaktyka napadów a zapobieganie epilepsji po urazach mózgu: analiza rejestrów ClinicalTrials.gov z lat 2000-2026

Preprint (medRxiv/bioRxiv)➕ 09.07.2026Preprint (medRxiv/bioRxiv)

Seizure Prophylaxis Versus Epilepsy Prevention After Acquired Brain Injury: A Cross-Sectional ClinicalTrials.gov Registry Analysis, 2000-2026

W skrócie

[Preprint - wstępne wyniki] Badacze przeanalizowali ponad 800 badań klinicznych dotyczących napadów padaczkowych po urazach mózgu, aby zrozumieć, jak lekarze wybierają leczenie w pierwszych fazach i długoterminowej profilaktyce. Odkryli, że większość badań skupia się na urazach mózgu i guzach mózgu, ale brakuje wyraźnych standardów w dawkowaniu leków i sposobie raportowania wyników. Naukowcy wnioskują, że przyszłe badania powinny lepiej rozróżniać krótkoterminowe hamowanie napadów od długoterminowego zapobiegania epilepsji oraz bardziej szczegółowo raportować wyniki.

Oryginalny abstract (angielski)

Abstract Background Seizures after acquired brain injury create distinct therapeutic questions: early seizure prophylaxis, treatment of acute symptomatic seizures, and prevention of late epilepsy. These endpoints are often conflated, although early seizure suppression does not establish disease-modifying antiepileptogenesis. Methods We performed a cross-sectional ClinicalTrials.gov registry analysis of studies first posted from January 1, 2000, through June 18, 2026. Four disease-specific seizure-related search blocks were deduplicated by NCT number and adjudicated into a primary seizure-management cohort or sensitivity/monitoring cohort. Data were extracted from ClinicalTrials.gov export files and final adjudicated CTG Excel workbooks. In response to clinical-review priorities, we added NCT-specific extraction of completed pharmacologic trials, antiseizure medication or study-drug dosing when explicitly present in registry fields, seizure-control endpoints, follow-up windows, and clinical, EEG/cEEG/ECoG, and MRI/CT/imaging markers. Results Searches yielded 1,054 exported records; after removal of duplicate NCT numbers, 878 unique records were screened. Final adjudication retained 85 primary-cohort studies and 39 sensitivity/monitoring records; 754 records were excluded. Reviewer agreement was substantial to almost perfect across inclusion, disease category, seizure-focus category, and intervention type (kappa range, 0.787–0.897). Primary-cohort activity was concentrated in brain tumor/neurosurgery (27/85, 31.8%) and traumatic brain injury (23/85, 27.1%). Trial focus included late epilepsy prevention (26/85, 30.6%), acute seizure prophylaxis (25/85, 29.4%), acute symptomatic seizure treatment (23/85, 27.1%), and monitoring/characterization or other ASM-use studies (11/85, 12.9%). Drug/ASM interventions accounted for 46/85 (54.1%). Among 26 completed trials eligible for registry results-reporting assessment, 11 (42.3%) had posted results. Completed medication/study-drug trials were clinically heterogeneous, and explicit dose fields were sparse and NCT-specific. Conclusions The registered evidence-generating pipeline for seizures after acquired brain injury is clinically important but fragmented. Future trials should separate acute seizure suppression from late epilepsy prevention, enrich enrollment using etiology-specific seizure-risk markers, predefine how clinical seizures, EEG/cEEG/ECoG, and imaging guide prophylaxis decisions and duration, and improve dose-level and results reporting. Clinical trial registration Clinical trial number: not applicable. This manuscript is a cross-sectional registry analysis and was not itself a clinical trial. NCT01463033 is an included ClinicalTrials.gov registry record; its ClinicalTrials.gov first-posted/registration date was November 1, 2011.

Metadane publikacji

Journal
Preprint (medRxiv/bioRxiv)
Data publikacji
07.07.2026
DOI
10.21203/rs.3.rs-10219486/v1
Europe PMC ID
PPR1273955
Autorzy
Chimakurthy A, Susarla V, Chaudhary JH, Desai O
Źródło
Preprint (medRxiv/bioRxiv)