An Open Label Study of Levetiracetam Monotherapy in Japanese Patients With Newly Diagnosed Focal Epilepsy
- Conditions
- Focal EpilepsyMedDRA version: 18.0Level: PTClassification code 10015037Term: EpilepsySystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2014-004377-16-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
- 70
- Subject is male or female and aged = 16 years at Visit 1
- Subjects with newly or recently diagnosed Epilepsy having experienced unprovoked Partial Seizures (IA, IB, IC), that are classifiable according to the International League Against Epilepsy (ILAE) classification of Epileptic Seizures
- Subjects with at least 2 unprovoked seizures separated by a minimum of 48 hours in the year prior to Visit 1, of which, at least 1 unprovoked seizure occurred in the 3 months prior to Visit 1
- Minimum body weight of 40 kg at Visit 1
Are the trial subjects under 18? yes
Number of subjects for this age range: 2
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 48
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
- Subject has a history or presence of seizure types other than partial (IA, IB, IC)
- Subject has an experience of any type of brain surgery in the consecutive 2 years prior to Visit 1
- Subject has a history or presence of known Pseudo-Seizures
- Subject has been treated for Epilepsy with any Antiepileptic Drug (AED) within the 6 months prior to Visit 1. However, acute and sub-acute seizure treatments are accepted for a maximum use of 2 weeks, if the treatments are stopped for the week prior to Visit 1
- Subject has a known clinically significant acute or chronic illness, such as but not restricted to: cardiac, renal, hepatic dysfunction, endocrinological, or psychiatric illness, and that may impair reliable participation in the study or necessitate the use of medication not allowed by the protocol
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this study is to evaluate the efficacy of LEV used as monotherapy,<br>with efficacy measured as 6-month seizure freedom at the last evaluated dose in the LEV 1000 mg/day to 2000 mg/day group, in newly or recently diagnosed epilepsy subjects.<br>;Secondary Objective: The secondary objectives of this study are the following:<br>- To evaluate the 1-year efficacy of LEV used as monotherapy at the last evaluated dose in the LEV 1000 mg/day to 2000 mg/day group<br>- To evaluate the efficacy of LEV used as monotherapy in subjects in the LEV 3000 mg/day group<br>- To evaluate the long-term safety of LEV used as monotherapy<br>;Primary end point(s): Percentage of Subjects in the Levetiracetam (LEV) 1000 mg/Day to 2000 mg/Day Group Who Are Seizure Free for 26 Consecutive Weeks of Treatment During the Evaluation Period;Timepoint(s) of evaluation of this end point: From the end of the 1-week Stabilization Period over the 26-weeks Evaluation Period
- Secondary Outcome Measures
Name Time Method