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A model-based cohort study of clobazam exposure and clinical efficacy and safety in children with drug-resistant epilepsy

A model-based cohort study of clobazam exposure and clinical efficacy and safety in children with drug-resistant epilepsy

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500100375
Enrollment
Unknown
Registered
2025-04-08
Start date
2024-08-29
Completion date
Unknown
Last updated
2025-04-14

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

Conditions

drug-resistant epilepsy

Interventions

Grouping according to clobazam exposure level (continuous variables):It was a cohort study without intervention.

Sponsors

Children’s Hospital of Soochow University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Months to 18 Years

Inclusion criteria

Inclusion criteria: 1. The age of the enrolled patients ranged from 1 month to 18 years. 2. Diagnosis of drug-resistant epilepsy. 3. Enrolled patients have already been treated with clobazam or newly treated with clobazam for antiepileptic therapy. 4. Sign informed consent.

Exclusion criteria

Exclusion criteria: 1. The type or dose of combined antiepileptic drugs still needs to be adjusted except clobazam. 2. Moderate to severe liver dysfunction (ALT/AST > 3 times the upper limit of normal). 3. Participants with renal failure requiring dialysis or expected to require dialysis during the study period. 4. Patients who could not be followed up regularly. 5. Patients with poor medication compliance. 6. Patients for whom surgical treatment is indicated.

Design outcomes

Primary

MeasureTime frame
Reduction rate of seizure frequency;Types and proportions of adverse events;

Countries

China

Contacts

Public ContactZengyan Zhu

Children’s Hospital of Soochow University

zhuzengyan7676@suda.edu.cn+86 137 7188 7067

Outcome results

None listed

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