Status:
COMPLETED
An Open Label Study of L059 (Levetiracetam) in Japanese Epilepsy Subjects With Generalized Tonic-clonic Seizures
Lead Sponsor:
UCB Pharma
Conditions:
Epilepsy
Generalized Tonic-clonic Seizures
Eligibility:
All Genders
4+ years
Phase:
PHASE3
Brief Summary
The investigators will provide Levetiracetam treatment to epilepsy subjects in Japan who are judged to benefit from continued treatment with Levetiracetam by the investigators and who are willing to c...
Eligibility Criteria
Inclusion
- The subject in Japan has completed either of the studies N01159 or N01363 or has discontinued the N01159 study due to lack of efficacy.
- The subject who is judged to benefit from continued treatment with Levetiracetam by the investigators
Exclusion
- Subjects with multiple protocol deviations during N01159 or N01363, such as missing laboratory data, and low or noncompliance with the study medication, and who the investigator considers not to have the potential to have deviations stopped are ineligible
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT01398956
Start Date
June 1 2011
End Date
April 1 2016
Last Update
August 15 2017
Active Locations (32)
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1
152
Fujisawa, Japan
2
112
Fukuoka, Japan
3
113
Fukuoka, Japan
4
165
Fukuoka, Japan