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A real-world study of the efficacy and safety of pramparel in the treatment of post-stroke epilepsy

A real-world study of the efficacy and safety of pramparel in the treatment of post-stroke epilepsy

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400079424
Enrollment
Unknown
Registered
2024-01-03
Start date
2024-01-24
Completion date
Unknown
Last updated
2024-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy

Interventions

Experimental group:Take prampanel

Sponsors

Shandong First Medical University affiliated Provincial Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1) Age =18 years old; 2) Epilepsy appeared 1 week after stroke, and there was no history of epilepsy before stroke, and seizures caused by other diseases of the brain and systemic diseases were excluded; 3) Meet the diagnostic criteria for focal epilepsy or bilateral tonic-clonic seizures secondary to focal epilepsy set by the International League against Epilepsy in 2017; 4) Seizures were not controlled during baseline when the patient was treated with a fixed and stable dose ASMs regimen; 5) The patients signed the informed consent and voluntarily participated in the study.

Exclusion criteria

Exclusion criteria: 1) Patients who did not enter the hospital directly; 2) Patients with missing clinical records; 3) Patients with malignant tumors or degenerative diseases of the central nervous system; 4) Patients with mental or intellectual disabilities; 5) Failure to follow up patients; 6) Patients with abnormal liver and kidney function

Design outcomes

Primary

MeasureTime frame
The frequency of seizures decreased by =50% after 12 months of treatment compared with before treatment;

Secondary

MeasureTime frame
The frequency of seizures decreased by =50% after 6 months of treatment compared with before treatment;Drug retention rate at 3 months;Drug retention rate at 6 months;Final maintenance dose of prampanel;The frequency of seizures decreased by =50% after 3 months of treatment compared with before treatment;

Countries

China

Contacts

Public ContactXuewu Liu

Shandong First Medical University affiliated Provincial Hospital

snlxw1966@163.com+86 137 9112 2679

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026