Prevention of epilepsy in stroke patients at high risk of developing unprovoked seizures: anti-epileptogenic effects of eslicarbazepine acetate

Bial - Portela & Ca, S.A.0 sites220 target enrollmentApril 12, 2019

Overview

No summary available.

Registry

who.int

Start Date

April 12, 2019

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Patients must meet ALL of the following criteria:
•1\. Male or female patient aged 18 years or above.
•2\. To have one of the following confirmed by magnetic resonance imaging (MRI)/computed tomography (CT):
•a. Acute ischaemic or intracerebral haemorrhagic stroke with
•\- an acute symptomatic seizure until 120 hours post\-stroke and
•\- cerebral cortex involvement OR
•b. Acute ischaemic stroke with
•\- National Institutes of Stroke Scale (NIHSS) \= 11 and
•\- cerebral cortex involvement and
•\- large\-artery atherosclerosis and/or territory of middle cerebral artery (MCA) OR

•Patients are to be excluded from the trial for ANY ONE of the following reasons:
•1\. Contraindication to ESL, i.e. known hypersensitivity to ingredients of ESL formulation or other carboxamide derivatives (e.g., oxcarbazepine, carbamazepine), or second or third degree atrioventricular (AV) block.
•2\. Known Han Chinese or Thai ancestry.
•3\. History of previous clinical cerebral cortical stroke (other than the one described in inclusion criteria no. 2 \- 3\) within the last two years prior to Visit 1a.
•4\. Sinus venous thrombosis.
•5\. Spontaneous sub\-arachnoid haemorrhage due to e.g. aneurysmatic or arteriovenous malformation.
•6\. History of USs prior to primary (index) stroke.
•7\. Impaired pre\-stroke level of function, i.e. modified Rankin Scale (mRS) score \> 3 prior to first stroke occurrence.
•8\. History of AED use within the last 2 years as defined in the list of not allowed AEDs.
•9\. Use of ESL, unless provided as IMP of this trial, and oxcarbazepine.