Post-stroke Epilepsy: Primary Prophylaxis Study

• Status: Recruiting
• Trial end date: 2023-07-31
• Target enrollment: 0
• Participant gender: All

Summary

Advance in stroke treatment have resulted in a dramatic reduction in the stroke mortality, however, the number of stroke survivors living with morbidity has increased significantly. As we know, post-stroke epilepsy has been identified as a significant clinical issue in stroke survivors and stroke is the most common cause of epilepsy in older adults and for patients aged more than 65, post-stroke epilepsy accounts for 30-50% of new-onset seizures. Our previous study documented seizures during stroke presentation and during hospitalization would worsen the overall morbidity and mortality, suggesting the importance of awareness in seizure care in acute ischemic stroke.

As current studies only focus on anti-seizure/anti-convulsion after the appearance of late-onset seizures, without the intervention of the epileptogenesis, it is important to develop a potential novel prophylactic treatment on patients with acute severe stroke to prevent from late occurrence of seizures and epilepsy.

We have previously done researches on the medications that might have potential of anti-epileptogenesis in pilocarpine-induced animal models, supporting the concept of antiepileptogenesis, giving intervention immediately following a brain insult.

The results of some earlier anecdotal reports or small studies on prophylactic use of antiepileptic drug (AED) therapy in stroke, either hemorrhagic or ischemic strokes, remain inconclusive. There still lacks a well-established case-control study on prophylaxis of post-stroke epilepsy, with the early intervention of AED therapy with potential of anti-epileptogenesis in the phase of epileptogenesis.

Based on our clinical experience, and laboratory researches, we have noted two non-conventional AEDs, levetiracetam (LEV) and perampanel (PER) with potential of anti-epileptogenesis. It is justified to evaluate if early administration of LEV or PER in patients with acute major stroke as a prophylactic therapy could hamper the development of epileptogenesis and the later post-stroke epilepsy.

We aim to conduct a randomized case-control study to evaluate if early prophylactic introduction of low dose AED therapy (LEV or PER) in patients with moderate to severe middle cerebral artery infarct, could prevent the development of post-stroke epilepsy (primary prevention).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cheng Kung University
• Collaborators: Ministry of Science and Technology, Taiwan; National Cheng-Kung University Hospital
• Treatments: Levetiracetam

Criteria

Inclusion Criteria:

• Patients with acute MCA infarct (NIHSS > 8) and confirmed by brain MRI studies (excluding lacunar infarct) during hospital admission

Exclusion Criteria:

• Patients with prior clinical history of major stroke, significant head injury, brain tumor, major psychiatric illness, progressive neurodegenerative disorder, CNS infection, epilepsy, which might be precipitating to seizures or history of use of AEDs, including LEV or PER, during pregnancy or lactation, history of inadequate medical compliance, or any other significant major systemic disease with safety concern, determined by physician