Clinical trial NCT00367432: A Long Term Follow up Administration Study of L059 (Levetiracetam) in Epilepsy Patients With Partial Onset Seizures
Official title: A Multicenter, Open, Long-term Follow-up Study to Evaluate the Safety and Efficacy of L059 (Levetiracetam) at Individual Optimal Dose Ranging From 500 to 3000 mg/Day in Twice Daily Administration in Subjects From 16 to 65 Years With Epilepsy Suffering From Partial Onset Seizures Whether or Not Secondarily Generalized Who Completed in a Previous Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Epilepsies
Partial
Keywords: Epilepsies
Partial
Keppra
levetiracetam
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2006-08-22
Enrollment: 398
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is planned to evaluate the safety and efficacy of L059 (levetiracetam) in long-term administration in patients who completed N01020 \[NCT00160165\] or N01221 \[NCT00280696\].


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Occurrence of Treatment-emergent Adverse Events During the Study Period (Until the Time of Approval Granted)
timeFrame: During the study period from Visit 1 (Week 0) to the Follow-up Visit (up to Month 60) until the time of approval granted
Secondary outcomes:
measure: Change From Baseline in N01221 [NCT00280696] in Partial (Type 1) Seizure Frequency Per Week During the First 16-week Period in This Study
timeFrame: Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study
measure: Seizure Frequency Per Week in Partial Seizures During the First 16-week Period in This Study
timeFrame: First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 ( Week 16)
measure: Response Status (Patients With a Percent Reduction in Partial Seizure Frequency of at Least 50% During the First 16-week Period in This Study From Baseline in N01221)
timeFrame: Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study
measure: Change From Baseline in N01221 [NCT00280696] in Simple Partial Seizure Frequency Per Week During the First 16-week Period in This Study
timeFrame: Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study
measure: Change From Baseline in N01221 [NCT00280696] in Complex Partial Seizure Frequency Per Week During the First 16-week Period in This Study
timeFrame: Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study
measure: Change From Baseline in N01221 [NCT00280696] in Secondary Generalized Seizure Frequency Per Week During the First 16-week Period in This Study
timeFrame: Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study
measure: Change From Baseline in N01221 [NCT00280696] in Simple and Complex Partial Seizure Frequency Per Week During the First 16-week Period in This Study
timeFrame: Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study
measure: Change From Baseline in N01221 [NCT00280696] in Other Types of Seizure Frequency Per Week During the First 16-week Period in This Study
timeFrame: Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study
Other outcomes:
Locations:
city: Aichi-gun
country: Japan
state: Aichi
city: Nagoya
country: Japan
state: Aichi
city: Hirosaki
country: Japan
state: Aomori
city: Matsudo
country: Japan
state: Chiba
city: Kitakyusyu
country: Japan
state: Fukuoka
city: Koga
country: Japan
state: Fukuoka
city: Kurume
country: Japan
state: Fukuoka
city: Fukuyama
country: Japan
state: Hiroshima
city: Asahikawa
country: Japan
state: Hokkaido
city: Hakodate
country: Japan
state: Hokkaido
city: Sapporo
country: Japan
state: Hokkaido
city: Kobe
country: Japan
state: Hyogo
city: Kahoku-gun
country: Japan
state: Ishikawa
city: Kanazawa
country: Japan
state: Ishikawa
city: Zentsuji
country: Japan
state: Kagawa
city: Koshi
country: Japan
state: Kumamoto
city: Tsu
country: Japan
state: Mie
city: Iwanuma
country: Japan
state: Miyagi
city: Sendai
country: Japan
state: Miyagi
city: Omura
country: Japan
state: Nagasaki
city: Kashihara
country: Japan
state: Nara
city: Nagaoka
country: Japan
state: Niigata
city: Beppu
country: Japan
state: Oita
city: Izumi
country: Japan
state: Osaka
city: Neyagawa
country: Japan
state: Osaka
city: Suita
country: Japan
state: Osaka
city: Takatsuki
country: Japan
state: Osaka
city: Iruma-gun
country: Japan
state: Saitama
city: Shimotsuga-gun
country: Japan
state: Tochigi
city: Shimotsuke
country: Japan
state: Tochigi
city: Komatsushima
country: Japan
state: Tokushima
city: Chiyoda-Ku
country: Japan
state: Tokyo
city: Kodaira
country: Japan
state: Tokyo
city: Kokubunji
country: Japan
state: Tokyo
city: Shinjuku-ku
country: Japan
state: Tokyo
city: Taito-ku
country: Japan
state: Tokyo
city: Ube
country: Japan
state: Yamaguchi
city: Aomori
country: Japan
city: Chiba
country: Japan
city: Fukuoka
country: Japan
city: Fukushima
country: Japan
city: Gifu
country: Japan
city: Hiroshima
country: Japan
city: Kagoshima
country: Japan
city: Kumamoto
country: Japan
city: Kyoto
country: Japan
city: Miyazaki
country: Japan
city: Niigata
country: Japan
city: Okayama
country: Japan
city: Osaka
country: Japan
city: Shizuoka
country: Japan
city: Toyama
country: Japan
city: Yamagata
country: Japan
Study officials:
affiliation: +1 877 822 9493
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References: