CompletedNCT00367432Updated Nov 13, 2020Results posted

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

A Phase 3 interventional study of Levetiracetam in Epilepsies and Partial, sponsored by UCB Japan Co. Ltd.. Completed at 53 sites in Japan. Open to participants aged 16 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-11-13.

Sponsored by UCB Japan Co. Ltd. · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 398
Allocation: Not applicable
Ages: 16 Years to 65 Years
Sex: All

Study 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 studied

Epilepsies
Partial

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Keywords

Epilepsies
Partial
Keppra
levetiracetam

In context

Epilepsy

1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.

This study's enrollment of 398 is above the median of 50 across 1,206 interventional studies indexed under Epilepsy.

Browse Epilepsy studies →

Lead sponsor

UCB Japan Co. Ltd. is the lead sponsor of 14 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 16 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

Exclusion Criteria:

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

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 398 participants (actual)

Study arms

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

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).
Also known as: Keppra

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Results

Posted Jan 16, 2012

Participant flow

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.

First Period (16 Weeks)

Participant flow — First Period (16 Weeks)
Milestone	Levetiracetam N01221 [NCT00280696]	Levetiracetam N01020 [NCT00160615]
Started	313	0
Completed	275	0
Not completed	38	0
Withdrew: Adverse event	6	0
Withdrew: Lack of efficacy	24	0
Withdrew: Withdrawal by subject	6	0
Withdrew: Other reason	2	0

Second Period (up to 54 Months)

Participant flow — Second Period (up to 54 Months)
Milestone	Levetiracetam N01221 [NCT00280696]	Levetiracetam N01020 [NCT00160615]
Started	275	85
Completed	188	69
Not completed	87	16
Withdrew: Adverse event	14	3
Withdrew: Lack of efficacy	59	5
Withdrew: Lost to follow-up	0	1
Withdrew: Withdrawal by subject	8	5
Withdrew: Other reason	6	2

Outcome measures

PrimaryOccurrence 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
Reported as:: Number · participants

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

SecondaryChange 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.

Time frame:: Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study
Reported as:: Median · Percent Reduction

Change From Baseline in N01221 [NCT00280696] in Partial (Type 1) Seizure Frequency Per Week During the First 16-week Period in This Study
Percent Reduction	Levetiracetam
Change From Baseline in N01221 [NCT00280696] in Partial (Type 1) Seizure Frequency Per Week During the First 16-week Period in This Study	22.00 ± 53.04

SecondarySeizure 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.

Time frame:: First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 ( Week 16)
Reported as:: Median · Seizures Per Week

Seizure Frequency Per Week in Partial Seizures During the First 16-week Period in This Study
Seizures Per Week	Levetiracetam
Seizure Frequency Per Week in Partial Seizures During the First 16-week Period in This Study	2.13 ± 7.32

SecondaryResponse 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.

Time frame:: Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study
Reported as:: Number · Participants

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)
Participants	Levetiracetam
Responders	74
Non-responders	239

SecondaryChange 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.

Time frame:: Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study
Reported as:: Median · Percent Reduction

Change From Baseline in N01221 [NCT00280696] in Simple Partial Seizure Frequency Per Week During the First 16-week Period in This Study
Percent Reduction	Levetiracetam
Change From Baseline in N01221 [NCT00280696] in Simple Partial Seizure Frequency Per Week During the First 16-week Period in This Study	39.84 ± 139.32

SecondaryChange 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.

Time frame:: Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study
Reported as:: Median · Percent Reduction

Change From Baseline in N01221 [NCT00280696] in Complex Partial Seizure Frequency Per Week During the First 16-week Period in This Study
Percent Reduction	Levetiracetam
Change From Baseline in N01221 [NCT00280696] in Complex Partial Seizure Frequency Per Week During the First 16-week Period in This Study	20.59 ± 85.94

SecondaryChange 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

Time frame:: Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study
Reported as:: Median · Percent Reduction

Change From Baseline in N01221 [NCT00280696] in Secondary Generalized Seizure Frequency Per Week During the First 16-week Period in This Study
Percent Reduction	Levetiracetam
Change From Baseline in N01221 [NCT00280696] in Secondary Generalized Seizure Frequency Per Week During the First 16-week Period in This Study	76.56 ± 249.71

SecondaryChange 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.

Time frame:: Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study
Reported as:: Median · Percent Reduction

Change From Baseline in N01221 [NCT00280696] in Simple and Complex Partial Seizure Frequency Per Week During the First 16-week Period in This Study
Percent Reduction	Levetiracetam
Change From Baseline in N01221 [NCT00280696] in Simple and Complex Partial Seizure Frequency Per Week During the First 16-week Period in This Study	20.71 ± 63.01

SecondaryChange 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).

Time frame:: Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study
Reported as:: Median · Percent Reduction

Change From Baseline in N01221 [NCT00280696] in Other Types of Seizure Frequency Per Week During the First 16-week Period in This Study
Percent Reduction	Levetiracetam
Change From Baseline in N01221 [NCT00280696] in Other Types of Seizure Frequency Per Week During the First 16-week Period in This Study	66.47 ± 71.28

Adverse events

Collected over Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Levetiracetam	—	64/398 (16.1%)	369/398 (92.7%)

Most frequent serious events

Showing 10 of 70

Most frequent serious events
Event	Levetiracetam
EpilepsyNervous system disorders	5/398
Status EpilepticusNervous system disorders	5/398
PneumoniaInfections and infestations	4/398
Anticonvulsant ToxicityInjury, poisoning and procedural complications	3/398
Skin LacerationInjury, poisoning and procedural complications	3/398
Abortion InducedSurgical and medical procedures	2/398
Anticonvulsant Drug Level IncreasedInvestigations	2/398
PyrexiaGeneral disorders	2/398
Abortion CompletePregnancy, puerperium and perinatal conditions	1/398
Acute PsychosisPsychiatric disorders	1/398

Most frequent other events

Showing 10 of 39

Most frequent other events
Event	Levetiracetam
NasopharyngitisInfections and infestations	308/398
SomnolenceNervous system disorders	159/398
ContusionInjury, poisoning and procedural complications	110/398
HeadacheNervous system disorders	96/398
DiarrhoeaGastrointestinal disorders	69/398
DizzinessNervous system disorders	63/398
PyrexiaGeneral disorders	52/398
ExcoriationInjury, poisoning and procedural complications	52/398
EczemaSkin and subcutaneous tissue disorders	47/398
ConstipationGastrointestinal disorders	45/398

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Levetiracetam
Mean	33.68 ± 11.18

Age, Customized
Age, Customized(participants)	Levetiracetam
Between 16 and 65 years	398

Sex: Female, Male
Sex: Female, Male(Participants)	Levetiracetam
Female	196
Male	202

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Levetiracetam
Japanese	396
Asian (other than Japanese)	2

Region of Enrollment
Region of Enrollment(participants)	Levetiracetam
Japan	398

Weight
Weight(Kilogram (kg))	Levetiracetam
Mean	60.39 ± 13.64

Study locations

53 sites

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

References and documents

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 13, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00367432
Lead sponsor: UCB Japan Co. Ltd.
Responsible party: Sponsor
First posted: Aug 22, 2006
Start date: Jul 2006
Primary completion: Dec 2010
Completion: Dec 2010
Results posted: Jan 16, 2012
Last update: Nov 13, 2020

Study contacts

UCB Clinical Trial Call Center

study director · +1 877 822 9493

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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