An Open Label Study of Levetiracetam in Japanese Pediatric Patients With Partial Seizures

• Conditions: EpilepsyPartial Seizures; MedDRA version: 17.1Level: PTClassification code 10015037Term: EpilepsySystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2014-004335-39-Outside-EU/EEA
• Lead Sponsor: CB Japan Co. Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-16
• Last Update Posted: 23 February 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

- The patient has partial Epilepsy and the diagnosis must be confirmed in the last 6 months
- The patients must be on a stable 1 or 2 anti-epileptic drug(s) treatment during the 4 weeks prior to Baseline and must have at least 8 partial seizures during the 8-week prospective Baseline Period
- Patient at the age of 4 to 16 years, and at the body weight of 11 to 82 kg

Are the trial subjects under 18? yes
Number of subjects for this age range: 70
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

- The patient has a treatable seizure etiology
- The patient has Epilepsy secondary to a progressive cerebral disease or any other progressively neurodegenerative disease, including Rasmussen and Landau-Kleffner diseases
- The patient has a history of status Epilepticus during the 3 months prior to Visit 1
- The patient has a past and present history of pseudo seizures
- The patient has a current diagnosis of Lennox-Gastaut syndrome

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified