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Efficacy and Safety of Levetiracetam Sustained-release Granules in the Treatment of Focal Epilepsy: A Prospective, Multicenter, Real-world Observational Study

Efficacy and Safety of Levetiracetam Sustained-release Granules in the Treatment of Focal Epilepsy: A Prospective, Multicenter, Real-world Observational Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600128542
Enrollment
Unknown
Registered
2026-07-22
Start date
2026-07-25
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

epilepsy

Interventions

Levetiracetam sustained-release granules treatment group:None

Sponsors

Shanghai General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
12 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Diagnosed with focal epilepsy in accordance with the classification and diagnostic criteria of the International League Against Epilepsy (ILAE), 2025; 2.Patients were treated with at least one antiseizure medication (ASM) before enrollment, with no levetiracetam contained in the current treatment regimen. Add-on treatment with levetiracetam sustained-release granules was required as judged by the attending physician; 3.All participants provided written informed consent (signed by legal guardians for minor patients); 4. Age >= 12 years old;

Exclusion criteria

Exclusion criteria: 1.Pregnant or lactating women; 2.Patients with hypersensitivity to levetiracetam sustained-release granules or their excipients; 3.Patients with other severe comorbidities requiring priority treatment; 4.Other patients deemed ineligible for this study by the investigator.

Design outcomes

Primary

MeasureTime frame
The 6-month response rate in patients treated with levetiracetam sustained-release granules;

Secondary

MeasureTime frame
The retention rates of levetiracetam sustained-release granules at 3 and 6 months of treatment;The seizure-free rate at 6 months of treatment with levetiracetam sustained-release granules, defined as the proportion of patients who achieved seizure-free status during LEV SR therapy;The seizure-free and response rates at 3 months of treatment with levetiracetam sustained-release granules;

Countries

China

Contacts

Public ContactWu Yuncheng

Shanghai General Hospital

drwu2006@163.com+86 18930313198

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026