Status:
COMPLETED
An Open Label Study of Levetiracetam Monotherapy in Patients With Newly Diagnosed Focal Epilepsy
Lead Sponsor:
UCB Japan Co. Ltd.
Conditions:
Epilepsy
Partial Onset Seizures
Eligibility:
All Genders
16+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy of Levetiracetam (LEV) used as monotherapy, with efficacy measured as 6-month seizure freedom at the last evaluated dose in the LEV 1000 mg/day to...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT01506882
Start Date
December 1 2011
End Date
April 1 2015
Last Update
December 31 2015
Active Locations (27)
Enter a location and click search to find clinical trials sorted by distance.
1
19
Aomori, Japan
2
33
Asaka, Japan
3
21
Daitō, Japan
4
12
Fujisawa, Japan