A Long Term Follow up Administration Study of L059 (Levetiracetam) in Epilepsy Patients With Partial Onset Seizures

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

Registration Number: EUCTR2014-004334-26-Outside-EU/EEA

Lead Sponsor: CB Japan Co. Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 398

Inclusion Criteria

Patients who participated in study N01221 [NCT00280696] and completed the evaluation period and transition period or patients who participated in study N01020 [NCT00160615]

Are the trial subjects under 18? yes
Number of subjects for this age range: 18
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 380
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

Female patients during pregnancy, delivery and lactation, or suspected of pregnancy

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary end point(s): Occurrence of Treatment-emergent Adverse Events During the Study Period (Until the Time of Approval Granted) <br>;Timepoint(s) of evaluation of this end point: During the study period from Visit 1 (Week 0) to the Follow-up Visit (up to Month 60) until the time of approval granted <br>;Main Objective: The primary objective was to continuously evaluate the safety of long-term administration at the dose range from LEV 500 mg/day to LEV 3000 mg/day in subjects who completed N01221 or N01020. <br>;Secondary Objective: The secondary objectives were to evaluate the efficacy of LEV on epileptic seizures during the first 16-week period at individualized optimal doses ranging from 500 mg/day to 3000 mg/day in subjects who completed N01221 or N01020, and to provide LEV for the subjects from N01221 and N01020 who had no treatment alternatives and were willing to use this drug continuously, and to whom the investigator judged that it was necessary to administer this drug through the study. <br>

Secondary Outcome Measures