Epilepsy, PartialPhase 3NCT00160628
Open Label Safety and Efficacy Study of Levetiracetam in Korean Patients With Epilepsy
A Phase 3 study testing Levetiracetam in people with Epilepsy, Partial, run by UCB Pharma.
Trial summary
A Korean open-label, community-based trial assessing the efficacy and safety of levetiracetam as adjunctive therapy in partial epilepsy. Similarity with a similar study conducted in Caucasian epileptic subjects will be assessed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy, Partial
- What is being tested?
- Levetiracetam
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Mar 2004to Oct 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Subjects with epilepsy experiencing partial seizures, whether or not secondarily generalized.
- Subjects must present between 3 and 42 partial seizures over the three months prior to protocol Visit 1.
- Use of one (1), but no more than two (2) concomitant marketed AEDs at the time of trial entry.
Who cannot join
- Subjects on felbamate with less than 18 months exposure.
- Subjects on vigabatrin, whose visual field has not been assessed as per recommendation of the manufacturer, i.e. every 6 months.
- Presence of known pseudoseizures within the last year.
- Presence of progressive cerebral disease, any other progressively degenerative neurological disease, or any cerebral tumors.
- Uncountable seizures (clusters) or history of convulsive status epilepticus within the last five years.
About this study
Official title: A Korean Open-label, Multi-center, Community-based Trial Assessing the Efficacy and Safety of Levetiracetam as Adjunctive Therapy in Adult Subjects With Uncontrolled Partial Epilepsy for Bridging Purpose With a Similar Study on Caucasian Epileptic Subjects
A Korean open-label, community-based trial assessing the efficacy and safety of levetiracetam as adjunctive therapy in partial epilepsy.
Similarity with a similar study conducted in Caucasian epileptic subjects will be assessed.
- Conditions
- Epilepsy, Partial
- Being tested
- Levetiracetam
- Keywords
- Epilepsy, Partial Onset Seizures, Keppra, Levetiracetam
- Medical subject headings
- Epilepsies, Partial, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevetiracetamDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate efficacy of levetiracetam in community based practice (seizure frequency per week over 16 weeks).
Secondary outcomes (1)
To assess safety of levetiracetam
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startMar 2004
- Primary completionOct 2004
- Study completionOct 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Epilepsy, PartialStudies 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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- UCB Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- UCB Clinical Trial Call Center, Study director, UCB Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00160628
- Sponsor's protocol ID
- N01099
- Status last verified
- Feb 2010
- First submitted
- 8 Sep 2005
- Last updated
- 26 Nov 2013
- Results posted
- No
Publications
Heo K, Lee BI, Yi SD, Huh K, Kim JM, Lee SA, Shin DJ, Song HK, Lee SK, Kim JY, Lu S, Dubois C, Tonner F. Efficacy and safety of levetiracetam as adjunctive treatment of refractory partial seizures in a multicentre open-label single-arm trial in Korean patients. Seizure. 2007 Jul;16(5):402-9. doi: 10.1016/j.seizure.2007.02.011. Epub 2007 Mar 19.
PubMed 17369059
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Korean Open-label, Multi-center, Community-based Trial Assessing the Efficacy and Safety of Levetiracetam as Adjunctive Therapy in Adult Subjects With Uncontrolled Partial Epilepsy for Bridging Purpose With a Similar Study on Caucasian Epileptic Subjects
- ClinicalTrials.gov ID
- NCT00160628
- Acronym / sponsor ID
- N01099
- Conditions
- Epilepsy, Partial
- Keywords
- Epilepsy, Partial Onset Seizures, Keppra, Levetiracetam
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- Mar 2004
- Primary completion
- Oct 2004 (actual)
- Study completion
- Oct 2004 (actual)
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Korean open-label, community-based trial assessing the efficacy and safety of levetiracetam as adjunctive therapy in partial epilepsy.
Similarity with a similar study conducted in Caucasian epileptic subjects will be assessed.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects with epilepsy experiencing partial seizures, whether or not secondarily generalized.
- Subjects must present between 3 and 42 partial seizures over the three months prior to protocol Visit 1.
- Use of one (1), but no more than two (2) concomitant marketed AEDs at the time of trial entry.
Key exclusion criteria (5 listed)
- Subjects on felbamate with less than 18 months exposure.
- Subjects on vigabatrin, whose visual field has not been assessed as per recommendation of the manufacturer, i.e. every 6 months.
- Presence of known pseudoseizures within the last year.
- Presence of progressive cerebral disease, any other progressively degenerative neurological disease, or any cerebral tumors.
- Uncountable seizures (clusters) or history of convulsive status epilepticus within the last five years.
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 | Drug | – |
Primary outcome
To evaluate efficacy of levetiracetam in community based practice (seizure frequency per week over 16 weeks).
1 secondary outcome
To assess safety of levetiracetam
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2013.
- Results publication: PubMed 17369059Heo K, Lee BI, Yi SD, Huh K, Kim JM, Lee SA, Shin DJ, Song HK, Lee SK, Kim JY, Lu S, Dubois C, Tonner F. Efficacy and safety of levetiracetam as adjunctive treatment of refractory partial seizures in a multicentre open-label single-arm trial in Korean patients. Seizure. 2007 Jul;16(5):402-9. doi: 10.1016/j.seizure.2007.02.011. Epub 2007 Mar 19.
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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
UCB Pharma
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Levetiracetam in people with Epilepsy, Partial, run by UCB Pharma.
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 26 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To evaluate efficacy of levetiracetam in community based practice (seizure frequency per week over 16 weeks).. 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 NCT00160628, 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 26 Nov 2013.