臨床研究等提出・公開システム

Prophylactic Administration of Perampanel for Post-Stroke Epilepsy(PROPELLER study)

PROPELLER study (PROPELLER study)

Yamada Shuichi

Nara Medical University Hospital

840 Shijo-cho, Kashihara, Nara

syamada@naramed-u.ac.jp

Yamada Shuichi

Nara Medical University Hospital

840 Shijo-cho, Kashihara, Nara

+81-744-22-3051

syamada@naramed-u.ac.jp

Not Recruiting

Oct. 04, 2023

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

prevention purpose

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

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)

Both

Stroke

Off-label prophylactic administration of drug for post-stroke epilepsy with Peranpanel 2 mg orally once daily before bedtime

Percentage of epilepsy incidence in the first 3 years after initiation of protocol treatment.

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.

+81-744-29-8835

Sept. 28, 2023

none