Open-label, single-arm, multi-center, pharmacokinetic, safety and tolerability study oflevetiracetam intravenous infusion in children (4 - 16 years old) with epilepsy.
Phase 1
- 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
- ot 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