drugset / Trial / NCT04759196

Generating Evidence on NonEpileptic, Stereotypical and Intermittent Symptoms (NESIS) in Chronic Subdural Hematomas

NCT04759196

Phase 4 Unknown 56 enrolled University of Sherbrooke
RandomizedParallel-groupDouble-blindTreatment

Summary

Some patients with chronic subdural hematomas and transient neurological symptoms do not respond to standard antiepileptic drugs. The investigators think that some of them could have cortical depression rather than epileptic discharges. After an intensive literature review, the investigators found out that some antiepileptic dugs (Lamotrigine, Topiramate) were found to be efficient to treat cortical depression in other conditions (migraine, subarachnoid hemorrhage). In contrast, some other drugs (Levetiracetam) were not proved to be efficient. Knowing that, the investigators want to compare the efficacy of Topiramate against Levetiracetam in two different groups, the NESIS group (based on a NESIS score of 4 or more - increased risk of cortical depression) versus a non-NESIS group (score of 3 or less - increased risk of epileptic discharges).

Timeline

Start
2021-03-01
Primary completion
2024-09
Completion
2024-12

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Levetiracetam Other / unclassified 1500 mg
Subject Topiramate Small molecule 100 mg

Indications