Perampanel for the prevention of post-stroke epilepsy- efficacy and safety

Phase 2

Recruiting

• Conditions: Stroke; Epilepsy; Stroke - Haemorrhagic; Stroke - Ischaemic; Neurological - Epilepsy

• Registration Number: ACTRN12618001984280
• Lead Sponsor: Alfred Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-11
• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 164

Inclusion Criteria

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

Exclusion Criteria

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
11. Unable to obtain informed consent from patient or substitute decision maker

Study & Design

• Study Type: Interventional
• Study Design: Not specified