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The Primary Prevention Study of Post-Ischemic Stroke Epilepsy
Sponsor study identifier
interventional
180
1 country
1
Study Start
August 1, 2020
Actual (reported)Primary Completion
July 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 1, 2020
Actual (reported)April 21, 2021
Actual (reported)April 26, 2021
Actual (reported)July 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
July 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
post-stroke epileptic seizure
Occurrence of epileptic seizure following acute stage of stroke
at least 14 days after stroke
The group receives oral levetiracetam.
The group receives oral perampanel.
The group receives oral placebo.
Administer levetiracetam powder once a day in eligible patients
Administer perampanel powder once a day in eligible patients
National Cheng Kung University Hospital
Tainan, 701, Taiwan
Chen YS, Sung PS, Lai MC, Huang CW. The Primary Prevention of Poststroke Epilepsy in Patients With Middle Cerebral Artery Infarct: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2023 Nov 24;12:e49412. doi: 10.2196/49412.
Chin-Wei Huang, MD, PhD
National Cheng-Kung University Hospital
First Submitted
April 21, 2021
First Posted
April 26, 2021
Study Start
August 1, 2020
Actual (reported)Primary Completion
July 31, 2023
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 26, 2021
Record last verified: 2021-04
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