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

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 Twice Daily Administration in Subjects From 16 to 65 Years With Epilepsy Suffering From Partial Onset Seizures Whether or Not Secondarily Generalized Who Completed in a Previous Study

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].

Study Overview

• Status: Completed
• Conditions: Epilepsies; Partial
• Intervention / Treatment: Drug: Levetiracetam

• Study Type: Interventional
• Enrollment (Actual): 398
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • 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
  • Toyama, Japan
  • Yamagata, Japan
  • Aichi
    • Aichi-gun, Aichi, Japan
    • Nagoya, Aichi, Japan
  • Aomori
    • Hirosaki, Aomori, Japan
  • Chiba
    • Matsudo, Chiba, Japan
  • Fukuoka
    • Kitakyusyu, Fukuoka, Japan
    • Koga, Fukuoka, Japan
    • Kurume, Fukuoka, Japan
  • Hiroshima
    • Fukuyama, Hiroshima, Japan
  • Hokkaido
    • Asahikawa, Hokkaido, Japan
    • Hakodate, Hokkaido, Japan
    • Sapporo, Hokkaido, Japan
  • Hyogo
    • Kobe, Hyogo, Japan
  • Ishikawa
    • Kahoku-gun, Ishikawa, Japan
    • Kanazawa, Ishikawa, Japan
  • Kagawa
    • Zentsuji, Kagawa, Japan
  • Kumamoto
    • Koshi, Kumamoto, Japan
  • Mie
    • Tsu, Mie, Japan
  • Miyagi
    • Iwanuma, Miyagi, Japan
    • Sendai, Miyagi, Japan
  • Nagasaki
    • Omura, Nagasaki, Japan
  • Nara
    • Kashihara, Nara, Japan
  • Niigata
    • Nagaoka, Niigata, Japan
  • Oita
    • Beppu, Oita, Japan
  • Osaka
    • Izumi, Osaka, Japan
    • Neyagawa, Osaka, Japan
    • Suita, Osaka, Japan
    • Takatsuki, Osaka, Japan
  • Saitama
    • Iruma-gun, Saitama, Japan
  • Tochigi
    • Shimotsuga-gun, Tochigi, Japan
    • Shimotsuke, Tochigi, Japan
  • Tokushima
    • Komatsushima, Tokushima, Japan
  • Tokyo
    • Chiyoda-Ku, Tokyo, Japan
    • Kodaira, Tokyo, Japan
    • Kokubunji, Tokyo, Japan
    • Shinjuku-ku, Tokyo, Japan
    • Taito-ku, Tokyo, Japan
  • Yamaguchi
    • Ube, Yamaguchi, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Drug: 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).; Other Names: Keppra

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in N01221 [NCT00280696] in Partial (Type 1) Seizure Frequency Per Week During the First 16-week Period in This Study	The change in partial (type 1) seizure frequency from Baseline is given as a percent reduction computed as: [ Weekly partial seizure frequency (Baseline)- Weekly partial seizure frequency (Evaluation Period)]/ [Weekly partial seizure frequency (Baseline)] x 100. Positive values in percent reduction means that the value has decreased from Baseline during the first 16-week Period. Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures.	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	Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures.	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)	The percent reduction from Baseline was computed as: [ Weekly seizure frequency (Baseline)- Weekly seizure frequency (Evaluation Period)]/ [Weekly seizure frequency (Baseline)] x 100. Responders are those patients with a percent reduction in partial seizure frequency of at least 50% from Baseline to first Evaluation Period in partial seizure frequency per week. Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures.	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	Change in simple partial seizure frequency is given as a percent reduction computed as: [ Weekly simple partial seizure frequency (Baseline)- Weekly simple partial seizure frequency (Evaluation Period)]/ [Weekly simple partial seizure frequency (Baseline)] x 100. Positive values in percent reduction means that the value has decreased from Baseline during the first 16-week Period. Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures.	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	Change in complex partial seizure frequency is given as a percent reduction computed as: [ Weekly complex partial seizure frequency (Baseline)- Weekly complex partial seizure frequency (Evaluation Period)]/ [Weekly complex partial seizure frequency (Baseline)] x 100. Positive values in percent reduction means that the value has decreased from Baseline during the first 16-week Period. Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures.	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 Secondary Generalized Seizure Frequency Per Week During the First 16-week Period in This Study	Change in secondary generalized seizure frequency is given as a percent reduction computed as: [ Weekly sec. generalized seizure frequency (Baseline)- Weekly sec. generalized seizure frequency (Evaluation Period)]/ [Weekly sec. generalized seizure frequency (Baseline)] x 100. Positive values in reduction means the value decreased from Baseline during the first 16-week Period. Secondary generalized seizures belong to one of the 3 groups: Simple partial sz evolving to gen sz; Complex partial sz evolving to gen sz; Simple partial sz evolving to Complex partial sz evolving to gen sz	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 and Complex Partial Seizure Frequency Per Week During the First 16-week Period in This Study	Change in simple and complex partial seizure frequency is given as a percent reduction computed as (simple and complex partial seizure frequency := A): [ Weekly A (Baseline)- Weekly A (Evaluation Period)]/ [Weekly A (Baseline)] x 100. Positive values in percent reduction means that the value has decreased from Baseline during the first 16-week Period. Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures.	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 Other Types of Seizure Frequency Per Week During the First 16-week Period in This Study	Change in other types of seizure frequency is given as a percent reduction computed as (other types of seizure frequency:= B): [ Weekly B (Baseline)- Weekly B (Evaluation Period)]/ [Weekly B (Baseline)] x 100. Positive values in percent reduction means that the value has decreased from Baseline during the first 16-week Period. Other types of Seizures are all seizures except Partial Seizures (Type 1).	Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study

Collaborators and Investigators

• Sponsor: UCB Japan Co. Ltd.
• Investigators: Study Director: UCB Clinical Trial Call Center, +1 877 822 9493

Publications and helpful links

Helpful Links

• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start: July 1, 2006
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: August 21, 2006
• First Submitted That Met QC Criteria: August 21, 2006
• First Posted (Estimate): August 22, 2006

Study Record Updates

• Last Update Posted (Actual): November 13, 2020
• Last Update Submitted That Met QC Criteria: October 19, 2020
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: levetiracetam; Keppra; Partial; Epilepsies
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Epilepsy; Seizures; Anticonvulsants; Nootropic Agents; Levetiracetam
• Other Study ID Numbers: N01222; 2014-004334-26 (EudraCT Number)