An Open Long Term Follow up Study of L059 (Levetiracetam) in Epilepsy Patients With Partial Onset Seizures
Information source: UCB
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Epilepsies, Partial
Intervention: Levetiracetam (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: UCB Official(s) and/or principal investigator(s):
UCB Clinical Trial Call Center, Study Director, Affiliation: +1 877 822 9493
Summary
This study is planned to evaluate the safety and efficacy of L059 (levetiracetam) in
long-term administration in patients who completed a previous study.
Clinical Details
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 b.i.d. Administration in Subjects With Epilepsy Suffering From Partial Onset Seizures Whether or Not Secondarily Generalized Who Completed a Previous Trial.
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: The long-term safety of L059 at the dose range from 500 to 3000 mg/day in subjects who participated in the preceding studies N01020 and N01021.
Secondary outcome: Percent reduction from baseline in the preceding study in Partial Seizure.Seizures Frequency per Week in Partial Seizures over the first period. Responder rate Percent reduction from baseline according to Type of Partial Epileptic Seizures.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients who participated in the preceding Levetiracetam studies (N01221 and N01020),
and completed the evaluation and transition period
Exclusion Criteria:
- Female patients during pregnancy, delivery and lactation or suspected of pregnancy.
Locations and Contacts
Aomori, Japan
Chiba, Japan
Fukuoka, Japan
Fukushima, Japan
Gifu, Japan
Hiroshima, Japan
Kagoshima, Japan
Kumamoto, Japan
Kyoto, Japan
Miyazaki, Japan
Niigata, Japan
Okayama, Japan
Osaka, Japan
Shizuoka, Japan
Tokyo, Japan
Toyama, Japan
Yamagata, Japan
Nagoya, Aichi, Japan
Aichi-gun, Aichi, Japan
Hirosaki, Aomori, Japan
Matsudo, Chiba, Japan
Kitakyusyu, Fukuoka, Japan
Kurume, Fukuoka, Japan
Koga, Fukuoka, Japan
Fukuyama, Hiroshima, Japan
Sapporo, Hokkaido, Japan
Asahikawa, Hokkaido, Japan
Hakodate, Hokkaido, Japan
Kobe, Hyogo, Japan
Kahoku-gun, Ishikawa, Japan
Kanazawa, Ishikawa, Japan
Zentsuji, Kagawa, Japan
Koshi, Kumamoto, Japan
Ukyo-ku, Kyoto, Japan
Tsu, Mie, Japan
Sendai, Miyagi, Japan
Iwanuma, Miyagi, Japan
Omura, Nagasaki, Japan
Kashihara, Nara, Japan
Nagaoka, Niigata, Japan
Beppu, Oita, Japan
Suita, Osaka, Japan
Takatsuki, Osaka, Japan
Izumi, Osaka, Japan
Neyagawa, Osaka, Japan
Iruma-gun, Saitama, Japan
Shimotsuga-gun, Tochigi, Japan
Kawachi-gun, Tochigi, Japan
Shimotsuke, Tochigi, Japan
Komatsujima, Tokushima, Japan
Kodaira, Tokyo, Japan
Chiyoda-Ku, Tokyo, Japan
Ube, Yamaguchi, Japan
Additional Information
Starting date: July 2006
Ending date: August 2009
Last updated: June 4, 2008
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