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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 Seizures
MedDRA 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
NameTimeMethod
Main Objective: ;Secondary Objective: ;Primary end point(s):
Secondary Outcome Measures
NameTimeMethod
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