CompletedNCT01063764Updated Mar 5, 2015Results posted

An Open Label Study of Levetiracetam in Japanese Pediatric Patients With Partial Seizures

A Phase 3 interventional study of Levetiracetam in Epilepsy and Partial Seizures, sponsored by UCB Japan Co. Ltd.. Completed at 29 sites in Japan. Open to participants aged 4 Years to 16 Years. Per ClinicalTrials.gov, last updated 2015-03-05.

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

Phase: Phase 3
Study type: Interventional
Enrollment: 73
Allocation: Not applicable
Ages: 4 Years to 16 Years
Sex: All

Study summary

Objective of the First Period: To evaluate the efficacy of Levetiracetam dry syrup at doses up to a maximum of 60 mg/kg/day or 3000 mg/day used as an adjunctive therapy in Japanese pediatric patients (4 to 16 years) with uncontrolled partial seizures despite treatment with 1 or 2 anti-epileptic drug(s).

Read the detailed description

Objectives of the Second Period: To provide the Levetiracetam treatment to subjects who are judged by the investigators to benefit from the long-term treatment and who are willing to continuously receive this drug. To continuously evaluate the safety of the Levetiracetam long-term administration at doses ranging from 20 mg/kg/day or 1000 mg/day to 60 mg/kg/day or 3000 mg/day in subjects who completed the First Period of this study.

Conditions studied

Epilepsy
Partial Seizures

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Keywords

Keppra
Levetiracetam
Children
Epilepsy
Partial Seizures

In context

Epilepsy

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

This study's enrollment of 73 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: 4 Years to 16 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

The patient has partial Epilepsy and the diagnosis must be confirmed in the last 6 months
The patients must be on a stable 1 or 2 anti-epileptic drug(s) treatment during the 4 weeks prior to Baseline and must have at least 8 partial seizures during the 8-week prospective Baseline Period
Patient at the age of 4 to 16 years, and at the body weight of 11 to 82 kg

Exclusion criteria

Exclusion Criteria:

The patient has a treatable seizure etiology
The patient has Epilepsy secondary to a progressive cerebral disease or any other progressively neurodegenerative disease, including Rasmussen and Landau-Kleffner diseases
The patient has a history of status Epilepticus during the 3 months prior to Visit 1
The patient has a past and present history of pseudo seizures
The patient has a current diagnosis of Lennox-Gastaut syndrome

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 73 participants (actual)

Study arms

Experimental
Levetiracetam
Open-label, single-arm
Drug: Levetiracetam

Interventions

DrugLevetiracetam
First Period: Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks. Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.
Also known as: Keppra

What researchers measure

Primary outcomes

Change From Baseline in Partial Seizure Frequency Per Week Over the 14-weeks Treatment Period
The change in partial seizure frequency from Baseline (B) over the Treatment Period (T) is given as a percentage reduction computed as: (B values- T values) / B values x 100. Positive values in percent reduction mean that the value decreased from Baseline during the first 14-week Period. Frequency per week of partial seizures = (Total number of partial seizures in a certain Period/number of observation days in the Period) x 7. Partial seizures can be classified into: * Simple partial seizures * Complex partial seizures * Partial seizures evolving to secondarily generalized seizures.
Time frame: From Baseline (Week 0-8) to the 14-weeks Treatment Period (First Period: 4 weeks Up-titration (Week 8-12) and 10 weeks Evaluation (Week 12-22)); Week 0-22
Incidence of Treatment-Emergent Adverse Events (TEAEs) During the Second Period (up to Three Years 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. Incidence of treatment-emergent AEs is reported by the percentage of subjects with at least one treatment-emergent AE.
Time frame: During the second Period from Visit 8 (Week 22) to the end of the Follow-up Period (up to three years until the time of approval granted)

Secondary outcomes

Change From Baseline in Partial Seizure Frequency Per Week Over the 10-week Evaluation Period
The change in partial seizure frequency from Baseline (B) over the Evaluation Period (E) is given as a percentage reduction computed as: (B values- E values) / B values x 100. Positive values in percent reduction mean that the value decreased from Baseline to the 10-week Evaluation Period. Frequency per week of partial seizures = (Total number of partial seizures in a certain Period/number of observation days in the Period) x 7. Partial seizures can be classified into: * Simple partial seizures * Complex partial seizures * Partial seizures evolving to secondarily generalized seizures.
Time frame: From Baseline (Week 0-8) to the 10-weeks Evaluation Period (Part of the first Period: Week 12 to Week 22)
Partial Seizure Frequency Per Week Over the 14-weeks Treatment Period
The seizure frequency per week was calculated as: Frequency per week of partial seizures = (Total number of partial seizures in the Treatment Period/number of days for observation in the Treatment Period) x 7. Partial 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: 14-weeks Treatment Period (First Period: 4 weeks Up-titration (Week 8-12) and 10 weeks Evaluation (Week 12-22))
Partial Seizure Frequency Per Week Over the 10-weeks Evaluation Period
The seizure frequency per week was calculated as: Frequency per week of partial seizures = (Total number of partial seizures in the Evaluation Period/number of days for observation in the Evaluation Period) x 7. Partial 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: 10-weeks Evaluation Period (Part of the first Period: Week 12 to Week 22)
Percentage of Partial Seizures 50 % Responders Over the 14-weeks Treatment Period
50 % responders are those subjects which have a 50 % or more reduction in the frequency of partial seizures from Baseline to the Treatment Period. The results show the percentage of participants that are 50 % responders. Partial 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: 14-weeks Treatment Period (First Period: 4 weeks Up-titration (Week 8-12) and 10 weeks Evaluation (Week 12-22))
Percentage of Partial Seizures 50 % Responders Over the 10-weeks Evaluation Period
50 % responders are those subjects which have a 50 % or more reduction in the frequency of partial seizures from Baseline to the Evaluation Period. The results show the percentage of participants that are 50 % responders. Partial 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: 10-weeks Evaluation Period (Part of the first Period: Week 12 to Week 22)
Number of Seizure-free Subjects Over the 14-weeks Treatment Period
Seizure-free means not having a seizure of type I (Partial seizure). Partial 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: 14-weeks Treatment Period (First Period: 4 weeks Up-titration (Week 8-12) and 10 weeks Evaluation (Week 12-22))
Number of Seizure-free Subjects Over the 10-weeks Evaluation Period
Seizure-free means not having a seizure of type I (Partial seizure). Partial 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: 10-weeks Evaluation Period (Part of the first Period: Week 12 to Week 22)
Incidence of Treatment-emergent Adverse Drug Reactions (ADRs) During the Second Period (up to Three Years Until the Time of Approval Granted)
An Adverse Drug Reaction (ADR) is an Adverse Event for which a causal relationship between the product and the occurrence is suspected. Incidence of ADRs is reported by the number of subjects with at least one ADR.
Time frame: During the second Period from Visit 8 (Week 22) to the end of the Follow-up Period (up to three years until the time of approval granted)
Change From Baseline in Partial Seizure Frequency Per Week for the Second Period (up to Three Years From Informed Consent Until the Time of Approval Granted)
The outcome was also calculated for each 3-month Period but here only the result for the total Second Evaluation Period (Second Period without following 6-weeks Withdrawal Period for withdrawers) is presented. Change in partial seizure frequency from Baseline (B) over Second Evaluation Period (E) is given as a percentage reduction computed as: (B values- E values) / B values x 100. Positive values in percent reduction show a decrease from Baseline. Frequency per week of partial seizures = (Total number of partial seizures in a certain Period/number of observation days in the Period) x 7.
Time frame: From Baseline (Week 0-8) until the time of approval granted (up to three years from date of informed consent (Week 0); without 6-weeks Withdrawal Period)

Results

Posted Jun 19, 2012

Participant flow

Full Analysis Set (FAS) includes all subjects taking at least one dose of study medication. Per-Protocol Set (PPS) is a subset of the FAS, consisting of subjects without major protocol violations affecting the primary efficacy variable.

1st Period (From Week 8 to Week 22)

Participant flow — 1st Period (From Week 8 to Week 22)
Milestone	Levetiracetam
Started	73
Completed	62
Not completed	11
Withdrew: Adverse event	4
Withdrew: Lack of efficacy	6
Withdrew: Withdrawal by subject	1

2nd Period (Week 22 to the End of Study)

Participant flow — 2nd Period (Week 22 to the End of Study)
Milestone	Levetiracetam
Started	55
Completed	35
Not completed	20
Withdrew: Adverse event	3
Withdrew: Lack of efficacy	9
Withdrew: Withdrawal by subject	7
Withdrew: Protocol violation	1

Outcome measures

PrimaryChange From Baseline in Partial Seizure Frequency Per Week Over the 14-weeks Treatment Period

The change in partial seizure frequency from Baseline (B) over the Treatment Period (T) is given as a percentage reduction computed as: (B values- T values) / B values x 100. Positive values in percent reduction mean that the value decreased from Baseline during the first 14-week Period. Frequency per week of partial seizures = (Total number of partial seizures in a certain Period/number of observation days in the Period) x 7. Partial seizures can be classified into: * Simple partial seizures * Complex partial seizures * Partial seizures evolving to secondarily generalized seizures.

Time frame:: From Baseline (Week 0-8) to the 14-weeks Treatment Period (First Period: 4 weeks Up-titration (Week 8-12) and 10 weeks Evaluation (Week 12-22)); Week 0-22
Reported as:: Median · Percent reduction

Change From Baseline in Partial Seizure Frequency Per Week Over the 14-weeks Treatment Period
Percent reduction	Levetiracetam
Change From Baseline in Partial Seizure Frequency Per Week Over the 14-weeks Treatment Period	43.21 (26.19 to 52.14)

PrimaryIncidence of Treatment-Emergent Adverse Events (TEAEs) During the Second Period (up to Three Years 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. Incidence of treatment-emergent AEs is reported by the percentage of subjects with at least one treatment-emergent AE.

Time frame:: During the second Period from Visit 8 (Week 22) to the end of the Follow-up Period (up to three years until the time of approval granted)
Reported as:: Number · percentage of participants

Incidence of Treatment-Emergent Adverse Events (TEAEs) During the Second Period (up to Three Years Until the Time of Approval Granted)
percentage of participants	Levetiracetam
Incidence of Treatment-Emergent Adverse Events (TEAEs) During the Second Period (up to Three Years Until the Time of Approval Granted)	98.2

SecondaryChange From Baseline in Partial Seizure Frequency Per Week Over the 10-week Evaluation Period

The change in partial seizure frequency from Baseline (B) over the Evaluation Period (E) is given as a percentage reduction computed as: (B values- E values) / B values x 100. Positive values in percent reduction mean that the value decreased from Baseline to the 10-week Evaluation Period. Frequency per week of partial seizures = (Total number of partial seizures in a certain Period/number of observation days in the Period) x 7. Partial seizures can be classified into: * Simple partial seizures * Complex partial seizures * Partial seizures evolving to secondarily generalized seizures.

Time frame:: From Baseline (Week 0-8) to the 10-weeks Evaluation Period (Part of the first Period: Week 12 to Week 22)
Reported as:: Median · Percent reduction

Change From Baseline in Partial Seizure Frequency Per Week Over the 10-week Evaluation Period
Percent reduction	Levetiracetam
Change From Baseline in Partial Seizure Frequency Per Week Over the 10-week Evaluation Period	39.02 (26.67 to 52.07)

SecondaryPartial Seizure Frequency Per Week Over the 14-weeks Treatment Period

The seizure frequency per week was calculated as: Frequency per week of partial seizures = (Total number of partial seizures in the Treatment Period/number of days for observation in the Treatment Period) x 7. Partial 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:: 14-weeks Treatment Period (First Period: 4 weeks Up-titration (Week 8-12) and 10 weeks Evaluation (Week 12-22))
Reported as:: Median · Seizures per week

Partial Seizure Frequency Per Week Over the 14-weeks Treatment Period
Seizures per week	Levetiracetam
Partial Seizure Frequency Per Week Over the 14-weeks Treatment Period	3.92 (0.93 to 17.08)

SecondaryPartial Seizure Frequency Per Week Over the 10-weeks Evaluation Period

The seizure frequency per week was calculated as: Frequency per week of partial seizures = (Total number of partial seizures in the Evaluation Period/number of days for observation in the Evaluation Period) x 7. Partial 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:: 10-weeks Evaluation Period (Part of the first Period: Week 12 to Week 22)
Reported as:: Median · Seizures per week

Partial Seizure Frequency Per Week Over the 10-weeks Evaluation Period
Seizures per week	Levetiracetam
Partial Seizure Frequency Per Week Over the 10-weeks Evaluation Period	3.90 (0.86 to 17.26)

SecondaryPercentage of Partial Seizures 50 % Responders Over the 14-weeks Treatment Period

50 % responders are those subjects which have a 50 % or more reduction in the frequency of partial seizures from Baseline to the Treatment Period. The results show the percentage of participants that are 50 % responders. Partial 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:: 14-weeks Treatment Period (First Period: 4 weeks Up-titration (Week 8-12) and 10 weeks Evaluation (Week 12-22))
Reported as:: Number · percentage of participants

Percentage of Partial Seizures 50 % Responders Over the 14-weeks Treatment Period
percentage of participants	Levetiracetam
Percentage of Partial Seizures 50 % Responders Over the 14-weeks Treatment Period	38.4 (27.2 to 50.5)

SecondaryPercentage of Partial Seizures 50 % Responders Over the 10-weeks Evaluation Period

50 % responders are those subjects which have a 50 % or more reduction in the frequency of partial seizures from Baseline to the Evaluation Period. The results show the percentage of participants that are 50 % responders. Partial 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:: 10-weeks Evaluation Period (Part of the first Period: Week 12 to Week 22)
Reported as:: Number · percentage of participants

Percentage of Partial Seizures 50 % Responders Over the 10-weeks Evaluation Period
percentage of participants	Levetiracetam
Percentage of Partial Seizures 50 % Responders Over the 10-weeks Evaluation Period	38.2 (26.7 to 50.8)

SecondaryNumber of Seizure-free Subjects Over the 14-weeks Treatment Period

Seizure-free means not having a seizure of type I (Partial seizure). Partial 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:: 14-weeks Treatment Period (First Period: 4 weeks Up-titration (Week 8-12) and 10 weeks Evaluation (Week 12-22))
Reported as:: Number · participants

Number of Seizure-free Subjects Over the 14-weeks Treatment Period
participants	Levetiracetam
Number of Seizure-free Subjects Over the 14-weeks Treatment Period	2

SecondaryNumber of Seizure-free Subjects Over the 10-weeks Evaluation Period

Time frame:: 10-weeks Evaluation Period (Part of the first Period: Week 12 to Week 22)
Reported as:: Number · participants

Number of Seizure-free Subjects Over the 10-weeks Evaluation Period
participants	Levetiracetam
Number of Seizure-free Subjects Over the 10-weeks Evaluation Period	3

SecondaryIncidence of Treatment-emergent Adverse Drug Reactions (ADRs) During the Second Period (up to Three Years Until the Time of Approval Granted)

An Adverse Drug Reaction (ADR) is an Adverse Event for which a causal relationship between the product and the occurrence is suspected. Incidence of ADRs is reported by the number of subjects with at least one ADR.

Time frame:: During the second Period from Visit 8 (Week 22) to the end of the Follow-up Period (up to three years until the time of approval granted)
Reported as:: Number · participants

Incidence of Treatment-emergent Adverse Drug Reactions (ADRs) During the Second Period (up to Three Years Until the Time of Approval Granted)
participants	Levetiracetam
Incidence of Treatment-emergent Adverse Drug Reactions (ADRs) During the Second Period (up to Three Years Until the Time of Approval Granted)	15

SecondaryChange From Baseline in Partial Seizure Frequency Per Week for the Second Period (up to Three Years From Informed Consent Until the Time of Approval Granted)

The outcome was also calculated for each 3-month Period but here only the result for the total Second Evaluation Period (Second Period without following 6-weeks Withdrawal Period for withdrawers) is presented. Change in partial seizure frequency from Baseline (B) over Second Evaluation Period (E) is given as a percentage reduction computed as: (B values- E values) / B values x 100. Positive values in percent reduction show a decrease from Baseline. Frequency per week of partial seizures = (Total number of partial seizures in a certain Period/number of observation days in the Period) x 7.

Time frame:: From Baseline (Week 0-8) until the time of approval granted (up to three years from date of informed consent (Week 0); without 6-weeks Withdrawal Period)
Reported as:: Median · Percent reduction

Change From Baseline in Partial Seizure Frequency Per Week for the Second Period (up to Three Years From Informed Consent Until the Time of Approval Granted)
Percent reduction	Levetiracetam
Change From Baseline in Partial Seizure Frequency Per Week for the Second Period (up to Three Years From Informed Consent Until the Time of Approval Granted)	41.32 (15.37 to 82.40)

Adverse events

Collected over Adverse Events (AEs) were collected over the whole study from Baseline (Visit 2) over the complete First Period (14 weeks plus up to 6-week Down-titration and Follow-up) and the Second Period (Week 22 to the end of study).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Levetiracetam	—	8/73 (11%)	66/73 (90.4%)

Most frequent serious events

Most frequent serious events
Event	Levetiracetam
GastroenteritisInfections and infestations	2/73
ConvulsionNervous system disorders	2/73
StrabismusEye disorders	1/73
Abdominal pain lowerGastrointestinal disorders	1/73
Acetonaemic vomitingGastrointestinal disorders	1/73
Dental cariesGastrointestinal disorders	1/73
PneumoniaInfections and infestations	1/73
Near drowningInjury, poisoning and procedural complications	1/73
Status epilepticusNervous system disorders	1/73
Conversion disorderPsychiatric disorders	1/73

Most frequent other events

Showing 10 of 33

Most frequent other events
Event	Levetiracetam
NasopharyngitisInfections and infestations	54/73
SomnolenceNervous system disorders	34/73
InfluenzaInfections and infestations	20/73
PyrexiaGeneral disorders	17/73
Upper respiratory tract infectionInfections and infestations	12/73
HeadacheNervous system disorders	10/73
DiarrhoeaGastrointestinal disorders	9/73
ContusionInjury, poisoning and procedural complications	8/73
GastroenteritisInfections and infestations	7/73
ConvulsionNervous system disorders	7/73

Baseline characteristics

Baseline Characteristics refer to the Full Analysis Set (FAS). FAS includes all subjects taking at least one dose of study medication.

Age, Continuous
Age, Continuous(years)	Levetiracetam
Mean	10.1 ± 3.4

Sex: Female, Male
Sex: Female, Male(Participants)	Levetiracetam
Female	32
Male	41

Region of Enrollment
Region of Enrollment(participants)	Levetiracetam
Japan	73

Age Categorical
Age Categorical(participants)	Levetiracetam
>=4 - <8 years	22
>=8 - <12 years	22
>=12 - <16 years	29

Body Weight
Body Weight(kilogram (kg))	Levetiracetam
Mean	32.43 ± 13.20

Height
Height(centimeter (cm))	Levetiracetam
Mean	134.55 ± 20.69

Body Mass Index (BMI)
Body Mass Index (BMI)(kilogram / meter^2 (kg/m^2))	Levetiracetam
Mean	17.15 ± 2.99

Hospitalization Status
Hospitalization Status(participants)	Levetiracetam
Yes	0
No	73

Study locations

29 sites

21
Chuo, Japan
12
Hakodate, Japan
22
Hamamatsu, Japan
28
Hiroshima, Japan
7
Izumi, Japan
9
Kobe, Japan
3
Kodaira, Japan
30
Koga, Japan
10
Koushi, Japan
31
Kurume, Japan
23
Kyoto, Japan
2
Nagaoka, Japan
5
Nagoya, Japan
6
Nagoya, Japan
8
Neyagawa, Japan
1
Niigata, Japan
27
Okayama, Japan
24
Osaka, Japan
25
Osaka, Japan
11
Sapporo, Japan
13
Sendai, Japan
4
Shizuoka, Japan
26
Takatsuki, Japan
16
Tokyo, Japan
17
Tokyo, Japan
15
Yachiyo, Japan
14
Yamagata, Japan
19
Yokohama, Japan
20
Yokohama, Japan

References and documents

Publications

Nakamura H, Osawa M, Yokoyama T, Yoshida K, Suzuki A. [Efficacy and safety of levetiracetam as adjunctive therapy in Japanese children with uncontrolled partial-onset seizures: multicenter and open-label study (N01223), short term evaluation]. Brain Nerve. 2013 Sep;65(9):1083-92. Japanese. PubMed 24018745 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 5, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01063764
Lead sponsor: UCB Japan Co. Ltd.
Responsible party: Sponsor
First posted: Feb 5, 2010
Start date: Jan 2010
Primary completion: Apr 2011
Completion: Oct 2013
Results posted: Jun 19, 2012
Last update: Mar 5, 2015

Study contacts

UCB Clinical Trial Call Center

study director · +1 877 822 9493 (UCB)

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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