prophylaxis of post-stroke epilepsy
Research type
Research Study
Full title
prevention of epilepsy in stroke patients at high risk of developing unprovoked seizures: anti-epileptogenic effects of eslicarbazepine acetate
IRAS ID
257867
Contact name
Matthias Koepp
Contact email
Sponsor organisation
Bial - Portela & Ca, S.A
Eudract number
2018-002747-29
Duration of Study in the UK
2 years, 6 months, 1 days
Research summary
This study will investigate the effect of an anti-epileptic drug named Eslicarbazepine acetate on patients who are at the risk of developing epileptic seizures within 7 days of having stroke. The patients will take either 800mg of Eslicarbazepine acetate (can be downtitrated to 400mg if required) or placebo for 30 days. they will be followed up for 17 months afterwards.
Summary of results
Prevention of epilepsy in stroke patients at high risk of developing unprovoked seizures: anti-epileptogenic effects of eslicarbazepine acetate.
Sponsor details:
Bial - Portela & Ca, S.A. À Av. da Siderurgia Nacional 4745-457 Coronado (S. Romão e S. Mamede), Portugal
Phone: +351 229866100
The trial was conducted in 19 active sites in 7 European countries and Israel: Austria (4 sites), Germany (6 sites), Italy (2 sites), Israel (2 sites), Portugal (1 site), Spain (1 site), Sweden (1 site) and in the United Kingdom (2 sites).
Date of first enrolment: 29-MAY-2019
Date of last patient completed: 11-SEP-2023 About 5-15% of all stroke patients experience a seizure within 2 years of stroke and stroke is the most common cause of epilepsy in the elderly population.
The primary objective of this trial was to assess if the study medicine (started within 96/120 hours after stroke occurrence and continued for 30 days) changed the incidence of Unprovoked Seizures within the first 6 months after starting the study medicine compared to placebo (inactive dummy medication).
A total of 129 patients were enrolled at 19 active trial centres in Europe and Israel. Of these, 125 patients were randomised (assigned to the study medicine or placebo). Two patients who were randomised did not take the study medicine/placebo due to withdrawal of consent (patient or patient’s family decision). Thus, a total of 123 (98.4%) randomised patients received at least one dose of study medicine/placebo (safety set) including 61 (98.4%) ESL (study medicine) group patients and 62 (98.4%) placebo group patients. Overall, of 125 (100%) patients in the randomised set, 92 (73.6%) patients completed the 6-month period, 86 (68.8%) patients completed the 12-month period and 84 (67.2%) patients completed the 18-month period. In general, the percentage of completers was similar between ESL and placebo at any timepoint. A total of 41 (32.8%) patients prematurely terminated the trial with similar frequencies in both treatment groups, most of them before Visit 3 (total: 19.2%; ESL: 16.1%; placebo: 22.2%).
Out of the 123 enrolled patients, 35 (28.5%) patients in total experienced at least one medical problem after randomisation that was possibly related to the study medicine. These were reported with a higher frequency in patients in the ESL group (23 patients, 37.7%) than in the placebo group (12 patients, 19.4%). Hyponatraemia (low sodium levels in the blood) (5 patients, 8.2% in the ESL group vs. 1 patient, 1.6% in the placebo group) was the most frequently reported possibly related medical problem after randomisation assessed as at least possibly related to the study medicine.
The main aim of the study was to compare the proportion of patients who experienced the first Unprovoked Seizure within the first 6 months after randomisation in the study medicine and placebo groups. This proportion was known as the failure rate.
The 6 months failure rate was lower in the ESL group than in the placebo group, although the treatment group difference was not statistically significant, meaning we cannot say with certainty that it was not due to chance.REC name
London - City & East Research Ethics Committee
REC reference
19/LO/0296
Date of REC Opinion
26 Jul 2019
REC opinion
Further Information Favourable Opinion