Clinical trial NCT01398956: An Open Label Study of L059 (Levetiracetam) in Japanese Epilepsy Subjects With Generalized Tonic-clonic Seizures
Official title: An Open-label, Multicenter, Long-term, Follow-up Study in Japan to Evaluate the Safety, Tolerability, and Efficacy of Adjunctive Treatment With Oral L059 (Levetiracetam) in Epilepsy Subjects With Generalized Tonic-clonic (GTC) Seizures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Epilepsy
Generalized Tonic-clonic Seizures
Keywords: Levetiracetam
Epilepsy
Generalized tonic-clonic seizures
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2011-07-21
Enrollment: 44
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 continuously receive this drug.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Incidence of Treatment Emergent Adverse Events During the Entire Study Period
timeFrame: Through study completion, an average of 3 years
Secondary outcomes:
measure: The Percentage Change in Generalized Tonic-Clonic (GTC) Seizure Frequency Per Week Over the Evaluation Period From Either of the Combined Baseline Periods of the Previous Studies (N01159 or N01363).
timeFrame: During the Treatment Period (up to 4.8 years)
measure: The Incidence of Adverse Drug Reactions During the Entire Study Period
timeFrame: Through study completion, an average of 3 years
Other outcomes:
Locations:
city: Fujisawa
country: Japan
facility: 152
city: Fukuoka
country: Japan
facility: 112
city: Fukuoka
country: Japan
facility: 113
city: Fukuoka
country: Japan
facility: 165
city: Fukuoka
country: Japan
facility: 166
city: Fukushima
country: Japan
facility: 187
city: Gifu
country: Japan
facility: 107
city: Himeji
country: Japan
facility: 162
city: Hiroshima
country: Japan
facility: 110
city: Hokkaido
country: Japan
facility: 117
city: Hokkaido
country: Japan
facility: 130
city: Hokkaido
country: Japan
facility: 176
city: Kagoshima
country: Japan
facility: 143
city: Kagoshima
country: Japan
facility: 156
city: Kodaira
country: Japan
facility: 120
city: Kokubunji
country: Japan
facility: 105
city: Koshi
country: Japan
facility: 306
city: Miyazaki
country: Japan
facility: 172
city: Miyazaki
country: Japan
facility: 179
city: Nagoya
country: Japan
facility: 305
city: Niigata
country: Japan
facility: 106
city: Niigata
country: Japan
facility: 153
city: Okayama
country: Japan
facility: 109
city: Osaka
country: Japan
facility: 174
city: Saitama
country: Japan
facility: 119
city: Sakai
country: Japan
facility: 147
city: Sakai
country: Japan
facility: 194
city: Sapporo
country: Japan
facility: 304
city: Tochigi
country: Japan
facility: 138
city: Tokyo
country: Japan
facility: 184
city: Tokyo
country: Japan
facility: 190
city: Ube
country: Japan
facility: 111
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References: