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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

Page last updated: August 23, 2015

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