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

NCT00367432 | Completed Phase 3 Results

• 2 other identifiers: N012222014-004334-26
• Study Type: interventional
• Target: 398
• Locations: 1 country
• Sites: 53

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 \[NCT00280696\].

Conditions

Epilepsies; Partial

Keywords

Epilepsies; Partial; Keppra; levetiracetam

Outcome Measures

Primary Outcomes (1)

• Occurrence of Treatment-emergent Adverse Events During the Study Period (Until the Time of Approval Granted)

  An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with the pharmaceutical product. Occurrence of treatment-emergent AEs is reported by the number of subjects with at least one treatment-emergent AE.

  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 (8)

• Change From Baseline in N01221 [NCT00280696] in Partial (Type 1) Seizure Frequency Per Week During the First 16-week Period in This Study

  Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study

• Seizure Frequency Per Week in Partial Seizures During the First 16-week Period in This Study

  First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 ( Week 16)

• 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)

  Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study

• Change From Baseline in N01221 [NCT00280696] in Simple Partial Seizure Frequency Per Week During the First 16-week Period in This Study

  Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study

• Change From Baseline in N01221 [NCT00280696] in Complex Partial Seizure Frequency Per Week During the First 16-week Period in This Study

  Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study

Study Arms (1)

Levetiracetam

EXPERIMENTAL

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).

Drug: Levetiracetam

Interventions

Levetiracetam 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).

Also known as: Keppra

Levetiracetam

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• UCB Japan Co. Ltd.: lead

Study Sites (53)

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Aichi-gun, Aichi-ken, Japan

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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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Related Links

• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Epilepsy

Interventions

Levetiracetam

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: UCB Clinical Trial Call Center
• Organization: UCB

+1 877 822 9493 (UCB)

Study Officials

• UCB Clinical Trial Call Center

  +1 877 822 9493

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2006
• First Posted: August 22, 2006
• Study Start: July 1, 2006
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: November 13, 2020
• Results First Posted: January 16, 2012

Record last verified: 2015-04

Locations

JP (53)