PROPELLER study

JRCT ID: jRCTs051230107

Registered date:04/10/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Stroke
• Date of first enrollment: 04/10/2023
• Target sample size: 54
• Study type: Interventional
• Intervention(s): Off-label prophylactic administration of drug for post-stroke epilepsy with Peranpanel 2 mg orally once daily before bedtime

Outcome(s)

• Primary Outcome: Percentage of epilepsy incidence in the first 3 years after initiation of protocol treatment.

Secondary Outcome

1) All mortality during the first 3 years after initiation of protocol treatment.
2) Stroke (cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage) in the 3 years after initiation of protocol treatment, regardless of whether it was new or recurrent. New or recurrent stroke is defined here as symptomatic and treated in some way.

Key inclusion & exclusion criteria

• Age minimum: >= 50age old
• Age maximum: < 90age old
• Gender: Both

Include criteria

1)Patients with subcortical hemorrhage available for registration within 1 week
2)Patients'age at onset between 50 and 90 years
3)Patients capable of oral intake,including tube feeding
4)Patients who have been fully informed of the details of this clinical research and who have given their written consent,either by the research subject or by a surrogate

Exclude criteria

1) Patients with a history of epilepsy
2) Patients taking antiepileptic drugs
3) Patients whose cerebral hemorrhage is known to be caused by a vascular malformation such as arteriovenous malformation or moyamoya disease, or is traumatic in nature
4) Patients with severe renal or hepatic impairment
5) Patients with pregnant or breast feeding
6) Patients with allergy to the target drug
7) Patients who are judged to be inappropriate as research subjects by the principal investigator (subinvestigator)

Related Information

• Primary Sponsor: Yamada Shuichi
• Source(s) of Monetary Support: Nara Medical University