Post-stroke Epilepsy: Primary Prophylaxis Study

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).

Conditions

• Middle Cerebral Artery Stroke

Interventions

DRUG

Levetiracetam Oral Product

Administer levetiracetam powder once a day in eligible patients

DRUG

Perampanel Oral Product

Administer perampanel powder once a day in eligible patients

DRUG

Placebo

Administer placebo powder once a day in eligible patients

Sponsors & Collaborators

• Ministry of Science and Technology, Taiwan

  collaborator OTHER_GOV

• National Cheng-Kung University Hospital

  collaborator OTHER

• National Cheng Kung University

  lead OTHER

Principal Investigators

• Chin-Wei Huang, MD, PhD · National Cheng-Kung University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-08-01

Primary Completion

2023-07-31

Completion

2023-07-31

Countries

• Taiwan

Study Locations