An Open Label Study of L059 (Levetiracetam) in Japanese Epilepsy Subjects With Generalized Tonic-clonic Seizures
Information source: UCB Pharma
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Epilepsy; Generalized Tonic-clonic Seizures
Intervention: Levetiracetam (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: UCB Pharma Official(s) and/or principal investigator(s): UCB Clinical Trial Call Center, Study Director, Affiliation: +1 877 822 9493 (UCB)
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.
Clinical Details
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 design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Incidence of treatment emergent adverse events during the entire study period.
Secondary outcome: The percentage reduction 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).The incidence of adverse drug reactions during the entire study period
Eligibility
Minimum age: 4 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
152, Fujisawa, Japan
112, Fukuoka, Japan
113, Fukuoka, Japan
165, Fukuoka, Japan
166, Fukuoka, Japan
187, Fukushima, Japan
107, Gifu, Japan
162, Himeji, Japan
110, Hiroshima, Japan
117, Hokkaido, Japan
130, Hokkaido, Japan
176, Hokkaido, Japan
143, Kagoshima, Japan
156, Kagoshima, Japan
120, Kodaira, Japan
105, Kokubunji, Japan
306, Koshi, Japan
172, Miyazaki, Japan
179, Miyazaki, Japan
305, Nagoya, Japan
106, Niigata, Japan
153, Niigata, Japan
109, Okayama, Japan
174, Osaka, Japan
119, Saitama, Japan
147, Sakai, Japan
194, Sakai, Japan
304, Sapporo, Japan
138, Tochigi, Japan
184, Tokyo, Japan
190, Tokyo, Japan
111, Ube, Japan
Additional Information
Starting date: June 2011
Last updated: July 26, 2015
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