Open-label, single-arm, multi-center, pharmacokinetic, safety and tolerability study oflevetiracetam intravenous infusion in children (4 - 16 years old) with epilepsy.
Phase 1
Active, not recruiting
- Conditions
- EpilepsyMedDRA version: 9.1Level: LLTClassification code 10015037Term: Epilepsy
- Registration Number
- EUCTR2006-005722-23-FR
- Lead Sponsor
- CB Pharma S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 33
Inclusion Criteria
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: ;Primary end point(s): ;Main Objective:
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms of levetiracetam in treating pediatric epilepsy?
How does intravenous levetiracetam compare to standard-of-care treatments in children with epilepsy?
Are there specific biomarkers that predict levetiracetam response in pediatric epilepsy patients?
What adverse events are associated with levetiracetam IV infusion in children and how are they managed?
What are the pharmacokinetic profiles of levetiracetam in pediatric epilepsy compared to other antiepileptic drugs?