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

Phase 3

Completed

• Conditions: Epilepsies; Partial
• Interventions: Drug: Levetiracetam

• Registration Number: NCT00367432
• Lead Sponsor: UCB Japan Co. Ltd.

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 \[NCT00280696\].

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07
• Study First Submitted: 2006-08-21
• Study First Submitted QC: 2006-08-21
• Study First Posted: 2006-08-22
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Results First Submitted: 2011-12-02
• Results First Submitted QC: 2011-12-02
• Results First Posted: 2012-01-16
• Status Verified: 2015-04
• Last Update Submitted: 2020-10-19
• Last Update Posted: 2020-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 398

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]

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Levetiracetam	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).

Primary Outcome Measures

Name	Time	Method
Occurrence of Treatment-emergent Adverse Events During the Study Period (Until the Time of Approval Granted)	During the study period from Visit 1 (Week 0) to the Follow-up Visit (up to Month 60) 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.

Secondary Outcome Measures

Name	Time	Method
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 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.
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	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.
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	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.
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)	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.
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	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.
Change From Baseline in N01221 [NCT00280696] in Simple and 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	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.
Change From Baseline in N01221 [NCT00280696] in Secondary Generalized 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 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
Change From Baseline in N01221 [NCT00280696] in Other Types of 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 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).