A Long Term Follow up Administration Study of L059 (Levetiracetam) in Epilepsy Patients With Partial Onset Seizures

NCT ID: NCT00367432

Last Updated: 2020-11-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

398 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2010-12-31

Brief Summary

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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 \[NCT00280696\].

Detailed Description

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Conditions

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Epilepsies Partial

Keywords

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Epilepsies Partial Keppra levetiracetam

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Levetiracetam

Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).

Group Type EXPERIMENTAL

Levetiracetam

Intervention Type DRUG

Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).

Interventions

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Levetiracetam

Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).

Intervention Type DRUG

Other Intervention Names

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Keppra

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UCB Japan Co. Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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UCB Clinical Trial Call Center

Role: STUDY_DIRECTOR

+1 877 822 9493

Locations

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Aichi-gun, Aichi-ken, Japan

Site Status

Nagoya, Aichi-ken, Japan

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Hirosaki, Aomori, Japan

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Matsudo, Chiba, Japan

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Kitakyushu, Fukuoka, Japan

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Koga, Fukuoka, Japan

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Kurume, Fukuoka, Japan

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Fukuyama, Hiroshima, Japan

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Asahikawa, Hokkaido, Japan

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Hakodate, Hokkaido, Japan

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Sapporo, Hokkaido, Japan

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Kobe, Hyōgo, Japan

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Kahoku-gun, Ishikawa-ken, Japan

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Kanazawa, Ishikawa-ken, Japan

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Zentsujichó, Kagawa-ken, Japan

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Kōshi, Kumamoto, Japan

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Tsu, Mie-ken, Japan

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Iwanuma, Miyagi, Japan

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Sendai, Miyagi, Japan

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Ōmura, Nagasaki, Japan

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Kashihara, Nara, Japan

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Nagaoka, Niigata, Japan

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Beppu, Oita Prefecture, Japan

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Izumi, Osaka, Japan

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Neyagawa, Osaka, Japan

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Suita, Osaka, Japan

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Takatsuki, Osaka, Japan

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Iruma-gun, Saitama, Japan

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Shimotsuga-gun, Tochigi, Japan

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Shimotsuke, Tochigi, Japan

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Komatsushimachō, Tokushima, Japan

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Chiyoda-Ku, Tokyo, Japan

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Kodaira, Tokyo, Japan

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Kokubunji, Tokyo, Japan

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Shinjuku-ku, Tokyo, Japan

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Taito-ku, Tokyo, Japan

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Ube, Yamaguchi, Japan

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Aomori, , Japan

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Chiba, , Japan

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Fukuoka, , Japan

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Fukushima, , Japan

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Gifu, , Japan

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Hiroshima, , Japan

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Kagoshima, , Japan

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Kumamoto, , Japan

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Kyoto, , Japan

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Miyazaki, , Japan

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Niigata, , Japan

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Okayama, , Japan

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Osaka, , Japan

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Shizuoka, , Japan

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Toyama, , Japan

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Yamagata, , Japan

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Countries

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Japan

Related Links

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Other Identifiers

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2014-004334-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

N01222

Identifier Type: -

Identifier Source: org_study_id