EpilepsyPhase 3NCT01506882
An Open Label Study of Levetiracetam Monotherapy in Patients With Newly Diagnosed Focal Epilepsy
A Phase 3 study testing Levetiracetam (LEV) in people with Epilepsy and Partial Onset Seizures, run by UCB Japan Co. Ltd. at 27 sites in Japan.
Trial summary
The purpose of this study is to evaluate the efficacy of Levetiracetam (LEV) used as monotherapy, with efficacy measured as 6-month seizure freedom at the last evaluated dose in the LEV 1000 mg/day to 2000 mg/day group, in newly or recently diagnosed epilepsy subjects. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Epilepsy, Partial Onset Seizures
- What is being tested?
- Levetiracetam (LEV)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 27 sitesJapan
- Study dates
- Dec 2011to Apr 2015
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subject is male or female and aged ≥ 16 years at Visit 1
- Subjects with newly or recently diagnosed Epilepsy having experienced unprovoked Partial Seizures (IA, IB, IC), that are classifiable according to the International League Against Epilepsy (ILAE) classification of Epileptic Seizures
- Subjects with at least 2 unprovoked seizures separated by a minimum of 48 hours in the year prior to Visit 1, of which, at least 1 unprovoked seizure occurred in the 3 months prior to Visit 1
- Minimum body weight of 40 kg at Visit 1
Who cannot join
- Subject has a history or presence of seizure types other than partial (IA, IB, IC)
- Subject has an experience of any type of brain surgery in the consecutive 2 years prior to Visit 1
- Subject has a history or presence of known Pseudo-Seizures
- Subject has been treated for Epilepsy with any Antiepileptic Drug (AED) within the 6 months prior to Visit 1. However, acute and sub-acute seizure treatments are accepted for a maximum use of 2 weeks, if the treatments are stopped for the week prior to Visit 1
- Subject has a known clinically significant acute or chronic illness, such as but not restricted to: cardiac, renal, hepatic dysfunction, endocrinological, or psychiatric illness, and that may impair reliable participation in the study or necessitate the use of medication not allowed by the protocol
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
Japan27 sites
19
Aomori
33
Asaka
21
Daitō
12
Fujisawa
14
Hamamatsu
11
Himeji
30
Hirosaki
8
Kagoshima
20
Kamakura
17
Kawasaki
3
Kitakyushu
26
Kodaira
9
Kokubunji
32
Kyoto
25
Miyakonojō
5
Nagoya Aichi
4
Nara
22
Okayama
15
Osaka
27
Osaka
13
Saitama
1
Sakai
29
Sapporo
24
Sayama
2
Toyonaka
7
Ube
18
Yamagata
About this study
Official title: An Open-label, Randomized, Multicenter Study to Evaluate the Efficacy and Safety of Levetiracetam Used as Monotherapy in Newly or Recently Diagnosed Epilepsy Patients Aged Older Than or Equal to 16 Years With Partial Seizures
The purpose of this study is to evaluate the efficacy of Levetiracetam (LEV) used as monotherapy, with efficacy measured as 6-month seizure freedom at the last evaluated dose in the LEV 1000 mg/day to 2000 mg/day group, in newly or recently diagnosed epilepsy subjects.
- Conditions
- Epilepsy, Partial Onset Seizures
- Being tested
- Levetiracetam (LEV)
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levetiracetam (LEV)Drug
Also called Keppra, E Keppra
- Active Substance: Levetiracetam
- Pharmaceutical Form: Film-coated tablet
- Concentration: LEV 250 mg, LEV 500 mg
- Frequency: Twice daily
- Route of Administration: Oral use
| Study group | Role | What they receive |
|---|---|---|
| Levetiracetam 1000 mg/day to 2000 mg/day group | Experimental | Subjects in the LEV 1000 mg/day to 2000 mg/day group receive the initial dose of LEV 1000 mg/day for the 1- week Stabilization Period and enter the Evaluation Period. Unless a seizure occurs during the Evaluation Period, the subjects will continue LEV 1000 mg/day for 26 weeks. If a seizure occurs during the Evaluation Period, the dose will be increased to 2000 mg/day and a restart of stabilization on LEV 2000 mg/day for 1 week is required prior to restarting the 26-weeks Evaluation Period on LEV 2000 mg/day.
The LEV dose could be decreased as a fallback option at the investigator's discretion, if the subject did not tolerate the LEV dosage, as evidenced by the development of an AE. The fallback option was permitted to be performed once for subjects on LEV 2000 mg/day at any time during the restarted Stabilization Period (SP), restarted Evaluation Period (EP), or Maintenance Period (MP), as well as for subjects on LEV 3000 mg/day at any time during the SP, EP, or MP. Receives: Drug: Levetiracetam (LEV) |
| Levetiracetam 3000 mg/day group | Experimental | Unless a seizure occurs, the subjects in this arm will continue LEV 3000 mg/day for 26 weeks. Subjects in the LEV 3000 mg/day group undergo a 4-week Up-Titration Period prior to the 1-week Stabilization Period.
They receive 1000 mg/day for 2 weeks and 2000 mg/day for 2 weeks during the Up-Titration Period and LEV 3000 mg/day for 1 week during the Stabilization Period.
The LEV dose could be decreased as a fallback option at the investigator's discretion, if the subject did not tolerate the LEV dosage, as evidenced by the development of an AE. The fallback option was permitted to be performed once for subjects on LEV 2000 mg/day at any time during the restarted Stabilization Period (SP), restarted Evaluation Period (EP), or Maintenance Period (MP), as well as for subjects on LEV 3000 mg/day at any time during the SP, EP, or MP. Receives: Drug: Levetiracetam (LEV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects in the Levetiracetam (LEV) 1000 mg/Day to 2000 mg/Day Group Who Are Seizure Free for 26 Consecutive Weeks of Treatment During the Evaluation Period
A subject was considered seizure free, if no seizure occurred during the 6 consecutive months (26 weeks) in the Evaluation Period. If one of the following occurred, the subject was not considered seizure free:
- A documented seizure during 6 consecutive months of the Evaluation Analysis Period
- Subject discontinued the study prematurely during the Evaluation Analysis Period
- Missing Seizure Count Case Report Forms (CRFs) prior to completing the Evaluation Analysis Period.
Measured: From the end of the 1-week Stabilization Period over the 26-weeks Evaluation Period
Secondary outcomes (7)
Percentage of Subjects in the Levetiracetam (LEV) 1000 mg/Day to 2000 mg/Day Group Who Are Seizure Free for 52 Consecutive Weeks of Treatment During the Evaluation Period and the Maintenance Period
Subjects who complete the 26-weeks Evaluation Period without having a seizure will continue receiving the same dose of LEV as in the Evaluation Period during the 26-weeks Maintenance Period unless a seizure occurs.
Measured: From entry in the 26-weeks Evaluation Period to the end of the 26-weeks Maintenance Period
Percentage of Subjects in the Levetiracetam (LEV) 3000 mg/Day Group Who Are Seizure Free for 26 Consecutive Weeks of Treatment During the Evaluation Period
A subject was considered seizure free, if no seizure occurred during the 6 consecutive months (26 weeks) in the Evaluation Period. If one of the following occurred, the subject was not considered seizure free:
- A documented seizure during 6 consecutive months of the Evaluation Analysis Period
- Subject discontinued the study prematurely during the Evaluation Analysis Period
- Missing Seizure Count Case Report Forms (CRFs) prior to completing the Evaluation Analysis Period.
Measured: From the end of the 1-week Stabilization Period over the 26-weeks Evaluation Period
Percentage of Subjects in the Levetiracetam (LEV) 3000 mg/Day Group Who Are Seizure Free for 52 Consecutive Weeks of Treatment During the Evaluation Period and the Maintenance Period
Subjects who complete the 26-weeks Evaluation Period without having a seizure will continue receiving LEV 3000 mg/day during the 26-weeks Maintenance Period unless a seizure occurs.
Measured: From entry in the 26-weeks Evaluation Period to the end of the 26-weeks Maintenance Period
Time to First Seizure at the Last Evaluated Dose in Subjects in the Levetiracetam (LEV) 1000 mg/Day to 2000 mg/Day Group
Time was measured from first day of last evaluated dose. Seizures during Stabilization were not considered.
The Median time to first seizure will be estimated from the Kaplan-Meier curve.
Measured: During Evaluation, Maintenance and Safety Follow Up Period after 1-week Stabilization Period, assessed up to 1 year
Time to Withdrawal at the Last Evaluated Dose in Subjects in the Levetiracetam (LEV) 1000 mg/Day to 2000 mg/Day Group
Median time to withdrawal will be estimated from the Kaplan-Meier curve.
Measured: During 1-week Stabilization Period, Evaluation, Maintenance and Safety Follow Up Period, assessed up to 1 year
Time to First Seizure in Subjects in the Levetiracetam (LEV) 3000 mg/Day Group
Time was measured from first day of last evaluated dose. Seizures during Stabilization were not considered.
The Median time to first seizure will be estimated from the Kaplan-Meier curve.
Measured: During Evaluation, Maintenance and Safety Follow Up Period after 1-week Stabilization Period, assessed up to 1 year
Time to Withdrawal in Subjects in the Levetiracetam (LEV) 3000 mg/Day Group
Median time to withdrawal will be estimated from the Kaplan-Meier curve.
Measured: During 1-week Stabilization Period, Evaluation, Maintenance and Safety Follow Up Period, assessed up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2012 (estimated)
- Study startDec 2011
- Primary completionOct 2013
- Study completionApr 2015
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 71 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
- NCT01506882
- Sponsor's protocol ID
- N01375
- Other IDs
- 2014-004377-16, 2014
- Status last verified
- Nov 2015
- First submitted
- 5 Jan 2012
- Last updated
- 31 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Multicenter Study to Evaluate the Efficacy and Safety of Levetiracetam Used as Monotherapy in Newly or Recently Diagnosed Epilepsy Patients Aged Older Than or Equal to 16 Years With Partial Seizures
- ClinicalTrials.gov ID
- NCT01506882
- Acronym / sponsor ID
- N01375
- Conditions
- Epilepsy, Partial Onset Seizures
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- UCB Japan Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 10 Jan 2012 (estimated)
- Results
- Posted 13 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy of Levetiracetam (LEV) used as monotherapy, with efficacy measured as 6-month seizure freedom at the last evaluated dose in the LEV 1000 mg/day to 2000 mg/day group, in newly or recently diagnosed epilepsy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levetiracetam 1000 mg/day to 2000 mg/day group | Experimental | Drug: Levetiracetam (LEV)Subjects in the LEV 1000 mg/day to 2000 mg/day group receive the initial dose of LEV 1000 mg/day for the 1- week Stabilization Period and enter the Evaluation Period. Unless a seizure occurs during the Evaluation Period, the subjects will continue LEV 1000 mg/day for 26 weeks. If a seizure occurs during the Evaluation Period, the dose will be increased to 2000 mg/day and a restart of stabilization on LEV 2000 mg/day for 1 week is required prior to restarting the 26-weeks Evaluation Period on LEV 2000 mg/day. The LEV dose could be decreased as a fallback option at the investigator's discretion, if the subject did not tolerate the LEV dosage, as evidenced by the development of an AE. The fallback option was permitted to be performed once for subjects on LEV 2000 mg/day at any time during the restarted Stabilization Period (SP), restarted Evaluation Period (EP), or Maintenance Period (MP), as well as for subjects on LEV 3000 mg/day at any time during the SP, EP, or MP. |
| Levetiracetam 3000 mg/day group | Experimental | Drug: Levetiracetam (LEV)Unless a seizure occurs, the subjects in this arm will continue LEV 3000 mg/day for 26 weeks. Subjects in the LEV 3000 mg/day group undergo a 4-week Up-Titration Period prior to the 1-week Stabilization Period. They receive 1000 mg/day for 2 weeks and 2000 mg/day for 2 weeks during the Up-Titration Period and LEV 3000 mg/day for 1 week during the Stabilization Period. The LEV dose could be decreased as a fallback option at the investigator's discretion, if the subject did not tolerate the LEV dosage, as evidenced by the development of an AE. The fallback option was permitted to be performed once for subjects on LEV 2000 mg/day at any time during the restarted Stabilization Period (SP), restarted Evaluation Period (EP), or Maintenance Period (MP), as well as for subjects on LEV 3000 mg/day at any time during the SP, EP, or MP. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Subject is male or female and aged ≥ 16 years at Visit 1
- Subjects with newly or recently diagnosed Epilepsy having experienced unprovoked Partial Seizures (IA, IB, IC), that are classifiable according to the International League Against Epilepsy (ILAE) classification of Epileptic Seizures
- Subjects with at least 2 unprovoked seizures separated by a minimum of 48 hours in the year prior to Visit 1, of which, at least 1 unprovoked seizure occurred in the 3 months prior to Visit 1
- Minimum body weight of 40 kg at Visit 1
Key exclusion criteria (5 listed)
- Subject has a history or presence of seizure types other than partial (IA, IB, IC)
- Subject has an experience of any type of brain surgery in the consecutive 2 years prior to Visit 1
- Subject has a history or presence of known Pseudo-Seizures
- Subject has been treated for Epilepsy with any Antiepileptic Drug (AED) within the 6 months prior to Visit 1. However, acute and sub-acute seizure treatments are accepted for a maximum use of 2 weeks, if the treatments are stopped for the week prior to Visit 1
- Subject has a known clinically significant acute or chronic illness, such as but not restricted to: cardiac, renal, hepatic dysfunction, endocrinological, or psychiatric illness, and that may impair reliable participation in the study or necessitate the use of medication not allowed by the protocol
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 |
|---|---|---|
| Levetiracetam (LEV)Also: Keppra, E Keppra* Active Substance: Levetiracetam * Pharmaceutical Form: Film-coated tablet * Concentration: LEV 250 mg, LEV 500 mg * Frequency: Twice daily * Route of Administration: Oral use | Drug | Levetiracetam 1000 mg/day to 2000 mg/day group, Levetiracetam 3000 mg/day group |
Primary outcome
Percentage of Subjects in the Levetiracetam (LEV) 1000 mg/Day to 2000 mg/Day Group Who Are Seizure Free for 26 Consecutive Weeks of Treatment During the Evaluation Period
Time frame: From the end of the 1-week Stabilization Period over the 26-weeks Evaluation Period
A subject was considered seizure free, if no seizure occurred during the 6 consecutive months (26 weeks) in the Evaluation Period. If one of the following occurred, the subject was not considered seizure free: * A documented seizure during 6 consecutive months of the Evaluation Analysis Period * Subject discontinued the study prematurely during the Evaluation Analysis Period * Missing Seizure Count Case Report Forms (CRFs) prior to completing the Evaluation Analysis Period.
7 secondary outcomes
Percentage of Subjects in the Levetiracetam (LEV) 1000 mg/Day to 2000 mg/Day Group Who Are Seizure Free for 52 Consecutive Weeks of Treatment During the Evaluation Period and the Maintenance Period
Time frame: From entry in the 26-weeks Evaluation Period to the end of the 26-weeks Maintenance Period
Percentage of Subjects in the Levetiracetam (LEV) 3000 mg/Day Group Who Are Seizure Free for 26 Consecutive Weeks of Treatment During the Evaluation Period
Time frame: From the end of the 1-week Stabilization Period over the 26-weeks Evaluation Period
Percentage of Subjects in the Levetiracetam (LEV) 3000 mg/Day Group Who Are Seizure Free for 52 Consecutive Weeks of Treatment During the Evaluation Period and the Maintenance Period
Time frame: From entry in the 26-weeks Evaluation Period to the end of the 26-weeks Maintenance Period
Time to First Seizure at the Last Evaluated Dose in Subjects in the Levetiracetam (LEV) 1000 mg/Day to 2000 mg/Day Group
Time frame: During Evaluation, Maintenance and Safety Follow Up Period after 1-week Stabilization Period, assessed up to 1 year
Time to Withdrawal at the Last Evaluated Dose in Subjects in the Levetiracetam (LEV) 1000 mg/Day to 2000 mg/Day Group
Time frame: During 1-week Stabilization Period, Evaluation, Maintenance and Safety Follow Up Period, assessed up to 1 year
Time to First Seizure in Subjects in the Levetiracetam (LEV) 3000 mg/Day Group
Time frame: During Evaluation, Maintenance and Safety Follow Up Period after 1-week Stabilization Period, assessed up to 1 year
Time to Withdrawal in Subjects in the Levetiracetam (LEV) 3000 mg/Day Group
Time frame: During 1-week Stabilization Period, Evaluation, Maintenance and Safety Follow Up Period, assessed up to 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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)
27 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 (LEV) in people with Epilepsy and Partial Onset Seizures, run by UCB Japan Co. Ltd. at 27 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 4 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 31 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 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 13 Oct 2014). 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?
Percentage of Subjects in the Levetiracetam (LEV) 1000 mg/Day to 2000 mg/Day Group Who Are Seizure Free for 26 Consecutive Weeks of Treatment During the Evaluation Period (time frame: From the end of the 1-week Stabilization Period over the 26-weeks Evaluation Period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Dec 2015.