EpilepsyPhase 3NCT01063764
An Open Label Study of Levetiracetam in Japanese Pediatric Patients With Partial Seizures
A Phase 3 study testing Levetiracetam in people with Epilepsy and Partial Seizures, run by UCB Japan Co. Ltd. at 29 sites in Japan.
Trial 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 more about this study
- Who is it for?
- Ages 4 to 16 years
- Conditions the study is for
- Epilepsy, Partial Seizures
- What is being tested?
- Levetiracetam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 29 sitesJapan
- Study dates
- Jan 2010to Oct 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
Japan29 sites
21
Chūō
12
Hakodate
22
Hamamatsu
28
Hiroshima
7
Izumi
9
Kobe
3
Kodaira
30
Koga
10
Kōshi
31
Kurume
23
Kyoto
2
Nagaoka
5
Nagoya
6
Nagoya
8
Neyagawa
1
Niigata
27
Okayama
24
Osaka
25
Osaka
11
Sapporo
13
Sendai
4
Shizuoka
26
Takatsuki
16
Tokyo
17
Tokyo
15
Yachiyo
14
Yamagata
19
Yokohama
20
Yokohama
About this study
Official title: An Open Label, Single-Arm, Multi-Center Study on the Efficacy, Safety and Pharmacokinetics of Levetiracetam in Pediatric Patients (4 to 16 Years) With Partial Seizures Despite Treatment With 1 or 2 Anti-Epileptic Drugs
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
- Epilepsy, Partial Seizures
- Being tested
- Levetiracetam
- Keywords
- Keppra, Levetiracetam, Children, Epilepsy, Partial Seizures
- Medical subject headings
- Epilepsy, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevetiracetamDrug
Also called Keppra
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.
| Study group | Role | What they receive |
|---|---|---|
| Levetiracetam | Experimental | Open-label, single-arm Receives: Drug: Levetiracetam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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 (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2010 (estimated)
- Study startJan 2010
- Primary completionApr 2011
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Japan Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Clinical Trial Call Center, Study director, +1 877 822 9493 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01063764
- Sponsor's protocol ID
- N01223
- Other IDs
- 2014-004335-39, 2014
- Status last verified
- Feb 2015
- First submitted
- 1 Feb 2010
- Last updated
- 5 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Single-Arm, Multi-Center Study on the Efficacy, Safety and Pharmacokinetics of Levetiracetam in Pediatric Patients (4 to 16 Years) With Partial Seizures Despite Treatment With 1 or 2 Anti-Epileptic Drugs
- ClinicalTrials.gov ID
- NCT01063764
- Acronym / sponsor ID
- N01223
- Conditions
- Epilepsy, Partial Seizures
- Keywords
- Keppra, Levetiracetam, Children, Epilepsy, Partial Seizures
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- UCB Japan Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 5 Feb 2010 (estimated)
- Results
- Posted 19 Jun 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Levetiracetam | Experimental | Drug: LevetiracetamOpen-label, single-arm |
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LevetiracetamAlso: KeppraFirst 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. | Drug | Levetiracetam |
Primary outcome
Change From Baseline in Partial Seizure Frequency Per Week Over the 14-weeks Treatment Period
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
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.
Incidence of Treatment-Emergent Adverse Events (TEAEs) During the Second Period (up to Three Years Until the Time of Approval Granted)
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)
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.
9 secondary outcomes
Change From Baseline in Partial Seizure Frequency Per Week Over the 10-week Evaluation Period
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
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
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
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
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
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
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)
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)
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 and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24018745Nakamura 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.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
UCB Clinical Trial Call Center study director
+1 877 822 9493 (UCB)
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Levetiracetam in people with Epilepsy and Partial Seizures, run by UCB Japan Co. Ltd. at 29 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jun 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Partial Seizure Frequency Per Week Over the 14-weeks Treatment Period (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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01063764, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2015.