Perampanel for the prevention of post-stroke epilepsy- efficacy and safety: a pilot phase II randomised controlled trial

Alfred Health0 sites164 target enrollmentDecember 11, 2018

Overview

No summary available.

Registry

who.int

Start Date

December 11, 2018

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

•1\. Radiological (CT, CT perfusion or MRI) evidence of acute cortical ischaemic stroke or lobar haemorrhage within 7 days of symptom onset
•If enrolment is feasible prior to obtaining MRI (or MRI is contraindicated), cortical involvement can be inferred by either (1\) evidence of large vessel (ICA, M1/M2\) occlusion on CT angiography at admission or (2\) clinical evidence of a cortical syndrome such as aphasia, neglect/inattention or visual field defect
•2\. No previous anti\-epileptic drug use
•3\. Able to give informed consent or proxy consent
•4\. Pre\-admission mRS\<4

•1\. Preadmission Modified Rankin Scale (mRS) \> 3
•2\. Acute stroke more than 7 days from onset
•3\. Previous ischaemic or haemorrhagic stroke within preceding 12 months
•4\. Significant risk factors for non stroke\-related epilepsy
•5\. Previously diagnosed epilepsy (excluding benign childhood epilepsies)
•6\. Additional epileptogenic intra\-cranial pathology
•7\. Previous intracranial surgery
•8\. History of major psychiatric morbidity (such as psychiatric illness requiring hospitalisation or history of psychosis, major depression or suicidality) within the last 2 years
•9\. Pregnant or breast\-feeding
•10\. Excessive alcohol or recreational drug use