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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00367432

Enrollment

398

Registered

2006-08-22

Start date

2006-07-31

Completion date

2010-12-31

Last updated

2020-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsies, Partial

Keywords

Epilepsies, Partial, Keppra, levetiracetam

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 \[NCT00280696\].

Interventions

DRUGLevetiracetam

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).

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
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 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.
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.
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 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 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).
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.

Countries

Japan

Participant flow

Recruitment details

The Full Analysis Set (FAS) includes all subjects to whom the investigational products are assigned after registration, excluding those with serious Good Clinical Practice violations , subjects not administered the investigational products and subjects for whom no data is available after assignment of the investigational products.

Pre-assignment details

Eligible subjects from preceding study N01221 \[NCT00280696\] entered the First Period of this study and those subjects from N01221 \[NCT00280696\] who completed the First Period and subjects from the study N01020 \[NCT00160615\] entered the Second Period. Participant Flow and Baseline Characteristics refer to the FAS.

Participants by arm

Arm	Count
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).	398
Total	398

Withdrawals & dropouts

Period	Reason	FG000	FG001
First Period (16 Weeks)	Adverse Event	6	0
First Period (16 Weeks)	Lack of Efficacy	24	0
First Period (16 Weeks)	Other Reason	2	0
First Period (16 Weeks)	Withdrawal by Subject	6	0
Second Period (up to 54 Months)	Adverse Event	14	3
Second Period (up to 54 Months)	Lack of Efficacy	59	5
Second Period (up to 54 Months)	Lost to Follow-up	0	1
Second Period (up to 54 Months)	Other Reason	6	2
Second Period (up to 54 Months)	Withdrawal by Subject	8	5

Baseline characteristics

Characteristic	Levetiracetam
Age, Continuous	33.68 years STANDARD_DEVIATION 11.18
Age, Customized Between 16 and 65 years	398 participants
Race/Ethnicity, Customized Asian (other than Japanese)	2 Participants
Race/Ethnicity, Customized Japanese	396 Participants
Region of Enrollment Japan	398 participants
Sex: Female, Male Female	196 Participants
Sex: Female, Male Male	202 Participants
Weight	60.39 Kilogram (kg) STANDARD_DEVIATION 13.64

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	369 / 398
serious Total, serious adverse events	64 / 398

Outcome results

Primary

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.

Time frame: During the study period from Visit 1 (Week 0) to the Follow-up Visit (up to Month 60) until the time of approval granted

Population: Safety Set includes all subjects from N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.

Arm	Measure	Value (NUMBER)
Levetiracetam	Occurrence of Treatment-emergent Adverse Events During the Study Period (Until the Time of Approval Granted)	381 participants

Secondary

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.