Post-stroke Epilepsy: Primary Prophylaxis Study

NCT04858841 | Unknown DMC

• 1 other identifier: A-BR-108-107
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• post-stroke epileptic seizure

  Occurrence of epileptic seizure following acute stage of stroke

  at least 14 days after stroke

Study Arms (3)

Levetiracetam

EXPERIMENTAL

The group receives oral levetiracetam.

Drug: Levetiracetam Oral Product

Perampanel

EXPERIMENTAL

The group receives oral perampanel.

Drug: Perampanel Oral Product

Placebo

PLACEBO COMPARATOR

The group receives oral placebo.

Drug: Placebo

Interventions

Levetiracetam Oral Product DRUG

Administer levetiracetam powder once a day in eligible patients

Also known as: keppra

Levetiracetam

Perampanel Oral Product DRUG

Administer perampanel powder once a day in eligible patients

Also known as: fycompa

Perampanel

Placebo DRUG

Administer placebo powder once a day in eligible patients

Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cheng Kung University: lead
• Ministry of Science and Technology, Taiwan: collaborator
• National Cheng-Kung University Hospital: collaborator

Study Sites (1)

National Cheng Kung University Hospital

Tainan, 701, Taiwan

RECRUITING

Related Publications (1)

• 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.

  PMID: 37999939 DERIVED

MeSH Terms

Conditions

Infarction, Middle Cerebral Artery

Interventions

Levetiracetam; perampanel

Condition Hierarchy (Ancestors)

Cerebral Infarction; Brain Infarction; Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cerebral Arterial Diseases; Intracranial Arterial Diseases; Stroke; Vascular Diseases; Cardiovascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Chin-Wei Huang, MD, PhD

  National Cheng-Kung University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chin-Wei Huang, MD, PhD

CONTACT

886-6-2353535; huangcw@mail.ncku.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blinded study
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: April 26, 2021
• Study Start: August 1, 2020
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: April 26, 2021

Record last verified: 2021-04

Locations

TW (1)