Antiepileptogenesis after stroke-trials and tribulations: Methodological challenges and recruitment results of a Phase II study with eslicarbazepine acetate.

There is currently no evidence to support the use of antiseizure medications to prevent unprovoked seizures following stroke. Experimental animal models suggested a potential antiepileptogenic effect for eslicarbazepine acetate (ESL), and a Phase II, multicenter, randomized, double-blind, placebo-controlled study was designed to test this hypothesis and assess whether ESL treatment for 1 month can prevent unprovoked seizures following stroke. We outline the design and status of this antiepileptogenesis study, and discuss the challenges encountered in its execution to date. Patients at high risk of developing unprovoked seizures after acute intracerebral hemorrhage or acute ischemic stroke were randomized to receive ESL 800 mg/d or placebo, initiated within 120 hours after primary stroke occurrence. Treatment continued until Day 30, then tapered off. Patients could receive all necessary therapies for stroke treatment according to clinical practice guidelines and standard of care, and are being followed up for 18 months. The primary efficacy endpoint is the occurrence of a first unprovoked seizure within 6 months after randomization ("failure rate"). Secondary efficacy assessments include the occurrence of a first unprovoked seizure during 12 months after randomization and during the entire study; functional outcomes (Barthel Index original 10-item version; National Institutes of Health Stroke Scale); post-stroke depression (Patient Health Questionnaire-9; PHQ-9); and overall survival. Safety assessments include the evaluation of treatment-emergent adverse events; laboratory parameters; vital signs; electrocardiogram; suicidal ideation and behavior (PHQ-9 question 9). The protocol aimed to randomize approximately 200 patients (1:1), recruited from 21 sites in seven European countries and Israel. Despite the challenges encountered, particularly during the COVID-19 pandemic, the study progressed and included a remarkable number of patients, with 129 screened and 125 randomized. Recruitment was stopped after 30 months, the first patient entered in May 2019, and the study is ongoing and following up on patients according to the Clinical Trial Protocol.

Epilepsy diagnosis after Covid-19: A population-wide study.

BACKGROUND: We aimed to investigate whether SARS-CoV-2 infection was associated with an increased risk of incident epilepsy. METHODS: National register-based matched study. Verified cases of SARS-CoV-2 infection were acquired from the system for communicable disease surveillance in Sweden (SmiNet) and linked to data from the National Patient Register (NPR) and Cause of Death register in Sweden. Cases and non-infected controls were compared using a Cox proportional hazards model. RESULTS: A total of 1,221,801 SARS-CoV-2 infected patients and 1,223,312 controls were included. Infection was not associated with an increased risk of epilepsy on a whole population level (HR 1.01, 95% CI 0.92-1.12). Statistically significant effects were observed in patients between 61 and 80 years (HR 1.66, 95% CI 1.37-2.02), also when adjusting for stroke, traumatic brain injury, tumours (same age group HR 1.50, 95% CI 1.24-1.82) and mechanical ventilation (HR 1.28, 95% CI 1.05-1.57). In patients 81-100 years, a similar significant difference was observed (HR 1.77, 95% CI 1.30-2.42), which remained after adjustment for stroke, traumatic brain injury and tumours (HR 1.51, 95% CI 1.10-2.05) but not when mechanical ventilation was included as a covariate (HR 1.34, 95% CI 0.97-1.84). CONCLUSIONS: On a whole population level, SARS-CoV-2 infections is not associated with an increased risk of epilepsy. In patients above 60 years, a moderately increased risk of epilepsy was observed. However, considering potential non-controllable bias and that Covid-19 patients in intensive care present with a lower risk than the general ICU population, the virus-induced epileptogenic effect is likely very small.

An online tool for information to women with epilepsy and therapeutic drug monitoring in pregnancy: Design and pilot study.

OBJECTIVE: Information to women with epilepsy on pregnancy-related antiseizure medication (ASM) issues and reliable tools for therapeutic drug monitoring (TDM) are important aspects of epilepsy care. We aimed to develop and test an online tool for patient education on pregnancy-related issues and communication with epilepsy nurses during pregnancy for women with epilepsy. METHODS: An existing national platform for online communication (1177.se) was used, and an online tool was developed by two epilepsy nurses, two neurologists, and an IT technician. The tool was launched as a complement to standard care, and patients deciding to use it were invited to participate in a survey of user experiences and knowledge questions. RESULTS: The online tool consists of two modules: one for patient education and one for TDM during pregnancy. The latter module allows scheduling of automatic reminders of blood tests that are sent to patients at set intervals. The epilepsy nurse can communicate results and suggested dose changes in the tool. A total of 48 women answered the survey: 28 had been invited to use the information module and 20 to use the TDM module. Patient experiences were generally good, and most users of the TDM module would prefer an online means of communication in future pregnancies. For epilepsy nurses, the tool provided good overview of patients currently pregnant and administrative advantages compared with traditional means of communication. SIGNIFICANCE: Online patient education and communication about TDM during pregnancy are feasible and can be a valuable part of future digitalization efforts in epilepsy care.