A Double-Blind, Randomized, Multicenter, Placebo-Controlled, In-Patient, Maximum 24 Day Study of Levetiracetam Oral Solution 20-50 mg/kg/day as Adjunctive Treatment of Refractory Partial Onset Seizures in Pediatric Epileptic Subjects Ranging in Age from 1 Month to Less Than 4 Years of Age.
- Conditions
- pediatric antiepilepticMedDRA version: 6.1Level: PTClassification code 10053551
- Registration Number
- EUCTR2004-000199-14-IT
- Lead Sponsor
- CB PHARMA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 220
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 Main Objective: ;Secondary Objective: ;Primary end point(s):
- Secondary Outcome Measures
Name Time Method