A Randomized, Double-Blind, Placebo-Controlled, Fixed Dose-Ranging Study to Assess the Safety, Tolerability, and Efficacy of Topiramate Oral Liquid and Sprinkle Formulations as an Adjunct to Concurrent Anticonvulsant Therapy for Infants (1 to 23 Months of Age, Inclusive) With Refractory Partial-Onset Seizures, With Open-Label Extensio
- Conditions
- Adjunct to Concurrent Anticonvulsant Therapy for Infants (1 to 23 Months of Age, Inclusive) With Refractory Partial-Onset SeizuresMedDRA version: 6.1Level: PTClassification code 10010145
- Registration Number
- EUCTR2005-001338-33-IT
- Lead Sponsor
- JANSSEN-CILAG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 240
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