EpilepsyPhase 3NCT00419393
Long Term Follow-up Study With Keppra XR (Levetiracetam XR) for Partial Seizures
A Phase 3 study testing Keppra XR (Levetiracetam XR) in people with Epilepsy, run by UCB Pharma at 35 sites in 4 countries.
Trial summary
To provide continued treatment of Keppra XR (Levetiracetam XR) and to assess the long term safety of Keppra XR in subjects with partial onset seizures. Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Keppra XR (Levetiracetam XR)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 35 sitesin 4 countries
- Study dates
- Dec 2007to Mar 2010
- 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 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects who were randomized into study N01280 [NCT00419094], and completed the 2 week up titration period
Who cannot join
- Subjects who did not meet the inclusion/exclusion criteria for N01280 [NCT00419094]
- Subjects who were discontinued prior to the end of titration period
Trial locations and contacts
35 sites in 4 countries.
35 sites in 4 countries
United States16 sites
Study site
Atlanta, Georgia
Study site
Bakersfield, California
Study site
Buffalo, New York
Study site
Camden, New Jersey
Study site
Cedarhurst, New York
Study site
Detroit, Michigan
Study site
Dothan, Alabama
Study site
Little Rock, Arkansas
Study site
Loxahatchee Groves, Florida
Study site
Northport, Alabama
Study site
Phoenix, Arizona
Study site
San Antonio, Texas
Study site
Suwanee, Georgia
Study site
Toledo, Ohio
Study site
Tulsa, Oklahoma
Study site
Witchita, Kansas
Poland8 sites
Study site
Bialystok
Study site
Gdansk
Study site
Katowice
Study site
Lodz
Study site
Lublin
Study site
Poznan
Study site
Szczecin
Study site
Warsaw
Russia6 sites
Study site
Kalingrad
Study site
Kazan'
Study site
Moscow
Study site
Saint Petersburg
Study site
Samara
Study site
Yaroslavl
Mexico5 sites
Study site
Aguascalientes
Study site
Guadalajara
Study site
Guadalajara Jalisco
Study site
Mexico City
Study site
Monterrey
About this study
Official title: An Open-label, Long Term Follow-up Study With Keppra XR (Levetiracetam XR) for Treatment of Partial-onset Seizures
To provide continued treatment of Keppra XR (Levetiracetam XR) and to assess the long term safety of Keppra XR in subjects with partial onset seizures.
- Conditions
- Epilepsy
- Being tested
- Keppra XR (Levetiracetam XR)
- Keywords
- Keppra XR, Levetiracetam XR, long term, 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.
Keppra XR (Levetiracetam XR)Drug
Also called Keppra XR
500 mg tablets, 1000 - 3000 mg/day, flexible dosing for duration of the study (planned: approximately 6 months-3 years).
| Study group | Role | What they receive |
|---|---|---|
| Keppra XR (Levetiracetam XR) | Experimental | 1000 - 3000 mg/day Keppra XR (Levetiracetam XR), flexible dosing, throughout the duration of the study (planned: approximately 6 months-3 years) Receives: Drug: Keppra XR (Levetiracetam XR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Who Experienced at Least 1 Treatment Emergent Adverse Event During the Actual Treatment Period (6 Months-2 Years)
An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Measured: Duration of the Treatment Period (6 months-2 years)
Number of Subjects Who Experienced at Least 1 Serious Treatment Emergent Adverse Event During the Actual Treatment Period (6 Months-2 Years)
A serious adverse event is any untoward medical occurrences in a subject administered study treatment, whether or not the event is related to treatment, with at least one of the follow outcomes: death, life-threatening, initial inpatient hospitalization or prolongation of hospitalization, significant or persistent disability/incapacity, congenital anomaly/birth defect, or an important medical event that may jeopardize the subject and require a medical/surgical intervention.
Measured: Duration of the Treatment Period (6 months-2 years)
Number of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event During the Actual Treatment Period
An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Measured: Duration of the Treatment Period (6 months-2 years)
Secondary outcomes (2)
Percentage of Subjects Remaining on Keppra XR Monotherapy From Study Entry Through 6 Months
Among subjects in the Efficacy (EFF) population entering the study on Keppra XR monotherapy and exposed for at least 6 months, is the percentage of subjects remaining on monotherapy treatment for at least 6 months.
Measured: Study entry through 6 months
Percentage of Subjects Remaining on Keppra XR Monotherapy From Study Entry Through 12 Months
Among subjects in the Efficacy (EFF) population entering the study on Keppra XR monotherapy and exposed for at least 6 months, is the percentage of subjects remaining on monotherapy treatment for at least 12 months.
Measured: Study entry through 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2007 (estimated)
- Study startDec 2007
- Primary completionMar 2010
- Study completionMar 2010
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Clinical Trial Call Center, MD, Study director, +1 877 822 9493 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00419393
- Sponsor's protocol ID
- N01281
- Other IDs
- 2007-000899-17
- Status last verified
- Jun 2011
- First submitted
- 4 Jan 2007
- Last updated
- 5 Sep 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Long Term Follow-up Study With Keppra XR (Levetiracetam XR) for Treatment of Partial-onset Seizures
- ClinicalTrials.gov ID
- NCT00419393
- Acronym / sponsor ID
- N01281
- Conditions
- Epilepsy
- Keywords
- Keppra XR, Levetiracetam XR, long term, partial seizures
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 8 Jan 2007 (estimated)
- Results
- Posted 13 Jul 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To provide continued treatment of Keppra XR (Levetiracetam XR) and to assess the long term safety of Keppra XR in subjects with partial onset seizures.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Keppra XR (Levetiracetam XR) | Experimental | Drug: Keppra XR (Levetiracetam XR)1000 - 3000 mg/day Keppra XR (Levetiracetam XR), flexible dosing, throughout the duration of the study (planned: approximately 6 months-3 years) |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects who were randomized into study N01280 [NCT00419094], and completed the 2 week up titration period
Key exclusion criteria (2 listed)
- Subjects who did not meet the inclusion/exclusion criteria for N01280 [NCT00419094]
- Subjects who were discontinued prior to the end of titration period
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 |
|---|---|---|
| Keppra XR (Levetiracetam XR)Also: Keppra XR500 mg tablets, 1000 - 3000 mg/day, flexible dosing for duration of the study (planned: approximately 6 months-3 years). | Drug | Keppra XR (Levetiracetam XR) |
Primary outcome
Number of Subjects Who Experienced at Least 1 Treatment Emergent Adverse Event During the Actual Treatment Period (6 Months-2 Years)
Time frame: Duration of the Treatment Period (6 months-2 years)
An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Number of Subjects Who Experienced at Least 1 Serious Treatment Emergent Adverse Event During the Actual Treatment Period (6 Months-2 Years)
Time frame: Duration of the Treatment Period (6 months-2 years)
A serious adverse event is any untoward medical occurrences in a subject administered study treatment, whether or not the event is related to treatment, with at least one of the follow outcomes: death, life-threatening, initial inpatient hospitalization or prolongation of hospitalization, significant or persistent disability/incapacity, congenital anomaly/birth defect, or an important medical event that may jeopardize the subject and require a medical/surgical intervention.
Number of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event During the Actual Treatment Period
Time frame: Duration of the Treatment Period (6 months-2 years)
An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
2 secondary outcomes
Percentage of Subjects Remaining on Keppra XR Monotherapy From Study Entry Through 6 Months
Time frame: Study entry through 6 months
Percentage of Subjects Remaining on Keppra XR Monotherapy From Study Entry Through 12 Months
Time frame: Study entry through 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
Related trials for Epilepsy
Not yet recruiting
Clinical Trial of SEEG for Drug-resistant Epilepsy
Drug-Resistant Epilepsy
RecruitingPhase 3
Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
Seizures, Lennox Gastaut Syndrome
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Focal Seizure, Epilepsy
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy
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, MD study director
+1 877 822 9493 (UCB)
35 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Keppra XR (Levetiracetam XR) in people with Epilepsy, run by UCB Pharma at 35 sites in 4 countries.
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 1 inclusion and 2 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 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States, Poland, Russia, Mexico. 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 Jul 2011). 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?
Number of Subjects Who Experienced at Least 1 Treatment Emergent Adverse Event During the Actual Treatment Period (6 Months-2 Years) (time frame: Duration of the Treatment Period (6 months-2 years)). The study lists 3 primary outcomes in all. 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 5 Sep 2014.