Epilepsy, PartialPhase 2NCT00152503
Study With Subjects 18-65 Years Old With Partial Onset Seizures Who Are Currently Taking Levetiracetam
A Phase 2 study testing Seletracetam (UCB44212) in people with Epilepsy, Partial, run by UCB Pharma SA at 17 sites in 2 countries.
Trial summary
This trial will evaluate the efficacy and safety of UCB44212 as add-on therapy in subjects with focal epilepsy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Epilepsy, Partial
- What is being tested?
- Seletracetam (UCB44212)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 17 sitesin 2 countries
- Study dates
- 31 Aug 2005to 12 May 2006
- Phase
- Phase 2
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males/Females from 18 to 65 years of age (minimum body weight of 40 kg)
- Subjects with a confirmed diagnosis of epilepsy suffering from partial onset seizures whether or not secondarily generalized
- Subjects who have been treated for epilepsy for >= 6 months and are currently uncontrolled while being treated with 1-3 concomitant AED(s), inclusive of levetiracetam (LEV)
- Female subjects without childbearing potential or those who are using an acceptable contraceptive method
Who cannot join
- Seizures occurring in clusters. Status epilepticus within 6 months of Visit 1. History of non-epileptic seizures
- Subjects on vigabatrin
- Subjects on felbamate, unless treatment has been continuous for >2 years
- Ongoing psychiatric disease other than mild controlled disorders
- Subjects with clinically significant organ dysfunction
- Known allergic reaction or intolerance to pyrrolidine derivatives and/or excipients
- Pregnant or lactating women
- Use of benzodiazepines (for any indication) taken at a higher frequency than an average of once a week, unless counted as one of the concomitant Antiepileptic Drug (AEDs).
Trial locations and contacts
17 sites in 2 countries.
17 sites in 2 countries
United States14 sites
Study site
Charlottesville, Virginia
Study site
Chesterfield, Missouri
Study site
Cincinnati, Ohio
Study site
Columbus, Ohio
Study site
Dallas, Texas
Study site
Detroit, Michigan
Study site
Little Rock, Arkansas
Study site
Milwaukee, Wisconsin
Study site
Nashville, Tennessee
Study site
Philadelphia, Pennsylvania
Study site
Phoenix, Arizona
Study site
Springfield, Illinois
Study site
St. Petersburg, Florida
Study site
Wichita, Kansas
Canada3 sites
Study site
Calgary
Study site
Edmonton, Alberta
Study site
Montreal
About this study
Official title: An Open Label, Exploratory, Dose-escalation, Multicenter Study Examining the Safety, Tolerability and Efficacy of Ucb 44212 (Seletracetam) Used at Doses of 10, 20, 40, and 80 mg b.i.d. (Total Daily Doses of 20 - 160 mg) Administration (Oral Capsules) in Adult Subjects (18 - 65 Years) With Refractory Epilepsy Suffering From Partial Onset Seizures Who Are Currently Receiving Levetiracetam (LEV) But Still Experiencing Seizures
This trial will evaluate the efficacy and safety of UCB44212 as add-on therapy in subjects with focal epilepsy.
- Conditions
- Epilepsy, Partial
- Being tested
- Seletracetam (UCB44212)
- Keywords
- Epilepsy, Partial Onset Seizures, Seletracetam, 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.
Seletracetam (UCB44212)Drug
- Pharmaceutical form: oral capsules
- Concentration: 2, 10 and 50 mg
- Route of administration: oral administration
| Study group | Role | What they receive |
|---|---|---|
| Seletracetam | Experimental | Escalating doses twice daily were to be administered. Receives: Drug: Seletracetam (UCB44212) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit and Overall by Period
Calculated as (7-day seizure frequency during the Treatment Period) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)), divided by the 7-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in partial onset seizure frequency from Baseline.
The Treatment Period consists of an 8-week Up-Titration Period (Visit 3/Week 5 to Visit 7/Week 12) and a 3-week Down-Titration Period (Visit 7/Week 13 to Visit 10/Week 15). Visit x includes the period from the beginning of Visit x-1 up to but not including Visit x.
Measured: During the Treatment Period (Week 5 to Week 15), compared to Baseline Period (Week 1 to Week 4)
Secondary outcomes (8)
Percent Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I + II + III) by Visit and Overall by Period
Calculated as (7-day seizure frequency during the Treatment Period) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)), divided by the 7-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in seizure frequency from Baseline.
The Treatment Period consists of an 8-week Up-Titration Period (Visit 3/Week 5 to Visit 7/Week 12) and a 3-week Down-Titration Period (Visit 7/Week 13 to Visit 10/Week 15). Visit x includes the period from the beginning of Visit x-1 up to but not including Visit x.
Measured: During the Treatment Period (Week 5 to Week 15), compared to Baseline Period (Week 1 to Week 4)
Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit and Overall by Period
Calculated as (7-day seizure frequency during the Treatment Period) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)), divided by the 7-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in partial onset seizure frequency from Baseline.
The Treatment Period consists of an 8-week Up-Titration Period (Visit 3/Week 5 to Visit 7/Week 12) and a 3-week Down-Titration Period (Visit 7/Week 13 to Visit 10/Week 15). Visit x includes the period from the beginning of Visit x-1 up to but not including Visit x.
Measured: During the Treatment Period (Week 5 to Week 15), compared to Baseline Period (Week 1 to Week 4)
Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I + II + III) by Visit and Overall by Period
Calculated as (7-day seizure frequency during the Treatment Period) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)), divided by the 7-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in seizure frequency from Baseline.
The Treatment Period consists of an 8-week Up-Titration Period (Visit 3/Week 5 to Visit 7/Week 12) and a 3-week Down-Titration Period (Visit 7/Week 13 to Visit 10/Week 15). Visit x includes the period from the beginning of Visit x-1 up to but not including Visit x.
Measured: During the Treatment Period (Week 5 to Week 15), compared to Baseline Period (Week 1 to Week 4)
Seizure Frequency Per Week (Type I) by Visit Over the Treatment Period and Overall by Period
Calculated as 7-day partial onset seizure (type I) frequency; The Treatment Period consists of an 8-week Up-Titration Period (Visit 3/Week 5 to Visit 7/Week 12) and a 3-week Down-Titration Period (Visit 7/Week 13 to Visit 10/Week 15). Visit x includes the period from the beginning of Visit x-1 up to but not including Visit x.
Measured: During the Treatment Period (Week 5 to Week 15)
Seizure Frequency Per Week (Type I+II+III) by Visit Over the Treatment Period and Overall by Period
Calculated as 7-day seizure frequency for all seizure types (type I+II+III). The Treatment Period consists of an 8-week Up-Titration Period (Visit 3/Week 5 to Visit 7/Week 12) and a 3-week Down-Titration Period (Visit 7/Week 13 to Visit 10/Week 15). Visit x includes the period from the beginning of Visit x-1 up to but not including Visit x.
Measured: During the Treatment Period (Week 5 to Week 15)
Percentage of Responder Subjects in Partial Onset Seizures (Type I) Over the Up-titration Period
A responder was defined as a subject with a >= 50% reduction in seizure frequency per week from the Baseline Period (Week 1 to Week 4) to the end of the Up-Titration Period.
Measured: During the Up-Titration Period (Week 5 to Week 12), compared to Baseline Period (Week 1 to Week 4)
Categorized Percentage Response to Treatment in Partial Onset Seizures (Type I) Over the Up-titration Period
Response to treatment in partial onset seizures (type I) over the up-titration period were analyzed by the percentage change from baseline (Week 1 to Week 4) in partial seizure frequency per week over the up-titration period, grouped in 4 categories: <-25%, -25% to <25%, 25% to <75%, and 75% to 100%.
Measured: During the Up-Titration Period (Week 5 to Week 12), compared to Baseline Period (Week 1 to Week 4)
Percent Change From Baseline in Seizure-free Days Per Week Over the Up-titration Period
A day was considered seizure-free, if no seizure was reported during 24 hours. A positive value indicates improvement from Baseline (Week 1 to Week 4).
Measured: During the Up-Titration Period (Week 5 to Week 12), compared to Baseline Period (Week 1 to Week 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2005 (estimated)
- Study start31 Aug 2005
- Primary completion12 May 2006
- Study completion12 May 2006
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 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Pharma SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Cares, Study director, UCB (+1 844 599 2273)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00152503
- Sponsor's protocol ID
- N01192
- Status last verified
- Oct 2022
- First submitted
- 7 Sep 2005
- Last updated
- 7 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Exploratory, Dose-escalation, Multicenter Study Examining the Safety, Tolerability and Efficacy of Ucb 44212 (Seletracetam) Used at Doses of 10, 20, 40, and 80 mg b.i.d. (Total Daily Doses of 20 - 160 mg) Administration (Oral Capsules) in Adult Subjects (18 - 65 Years) With Refractory Epilepsy Suffering From Partial Onset Seizures Who Are Currently Receiving Levetiracetam (LEV) But Still Experiencing Seizures
- ClinicalTrials.gov ID
- NCT00152503
- Acronym / sponsor ID
- N01192
- Conditions
- Epilepsy, Partial
- Keywords
- Epilepsy, Partial Onset Seizures, Seletracetam, Levetiracetam
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- UCB Pharma SAIndustry (pharma, biotech, devices)
- Study start
- 31 Aug 2005 (actual)
- Primary completion
- 12 May 2006 (actual)
- Study completion
- 12 May 2006 (actual)
- First posted
- 9 Sep 2005 (estimated)
- Results
- Posted 7 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial will evaluate the efficacy and safety of UCB44212 as add-on therapy in subjects with focal epilepsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Seletracetam | Experimental | Drug: Seletracetam (UCB44212)Escalating doses twice daily were to be administered. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males/Females from 18 to 65 years of age (minimum body weight of 40 kg)
- Subjects with a confirmed diagnosis of epilepsy suffering from partial onset seizures whether or not secondarily generalized
- Subjects who have been treated for epilepsy for >= 6 months and are currently uncontrolled while being treated with 1-3 concomitant AED(s), inclusive of levetiracetam (LEV)
- Female subjects without childbearing potential or those who are using an acceptable contraceptive method
Key exclusion criteria (8 listed)
- Seizures occurring in clusters. Status epilepticus within 6 months of Visit 1. History of non-epileptic seizures
- Subjects on vigabatrin
- Subjects on felbamate, unless treatment has been continuous for >2 years
- Ongoing psychiatric disease other than mild controlled disorders
- Subjects with clinically significant organ dysfunction
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 |
|---|---|---|
| Seletracetam (UCB44212)* Pharmaceutical form: oral capsules * Concentration: 2, 10 and 50 mg * Route of administration: oral administration | Drug | Seletracetam |
Primary outcome
Percent Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit and Overall by Period
Time frame: During the Treatment Period (Week 5 to Week 15), compared to Baseline Period (Week 1 to Week 4)
Calculated as (7-day seizure frequency during the Treatment Period) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)), divided by the 7-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in partial onset seizure frequency from Baseline. The Treatment Period consists of an 8-week Up-Titration Period (Visit 3/Week 5 to Visit 7/Week 12) and a 3-week Down-Titration Period (Visit 7/Week 13 to Visit 10/Week 15). Visit x includes the period from the beginning of Visit x-1 up to but not including Visit x.
8 secondary outcomes
Percent Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I + II + III) by Visit and Overall by Period
Time frame: During the Treatment Period (Week 5 to Week 15), compared to Baseline Period (Week 1 to Week 4)
Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit and Overall by Period
Time frame: During the Treatment Period (Week 5 to Week 15), compared to Baseline Period (Week 1 to Week 4)
Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I + II + III) by Visit and Overall by Period
Time frame: During the Treatment Period (Week 5 to Week 15), compared to Baseline Period (Week 1 to Week 4)
Seizure Frequency Per Week (Type I) by Visit Over the Treatment Period and Overall by Period
Time frame: During the Treatment Period (Week 5 to Week 15)
Seizure Frequency Per Week (Type I+II+III) by Visit Over the Treatment Period and Overall by Period
Time frame: During the Treatment Period (Week 5 to Week 15)
Percentage of Responder Subjects in Partial Onset Seizures (Type I) Over the Up-titration Period
Time frame: During the Up-Titration Period (Week 5 to Week 12), compared to Baseline Period (Week 1 to Week 4)
Categorized Percentage Response to Treatment in Partial Onset Seizures (Type I) Over the Up-titration Period
Time frame: During the Up-Titration Period (Week 5 to Week 12), compared to Baseline Period (Week 1 to Week 4)
Percent Change From Baseline in Seizure-free Days Per Week Over the Up-titration Period
Time frame: During the Up-Titration Period (Week 5 to Week 12), compared to Baseline Period (Week 1 to Week 4)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Epilepsy, Partial
Not yet recruiting
Peri-procedural Weighted Blanket Use for ECT
Post-ect Agitation, Post-ictal Agitation
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Enrolling by invitationPhase 2
SPN-817 Open-Label Extension Study in Adults With Focal Onset Seizures
Focal Onset Seizures
Active, not recruitingPhase 4
Open-label Study of Cenobamate Monotherapy in Adult Subjects With Newly Diagnosed or Recurrent Partial-Onset Epilepsy
Focal Onset Seizure
RecruitingObservational study
Surgery as a Treatment for Medically Intractable Epilepsy
Epilepsy, Epilepsy, Temporal Lobe
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 Cares study director
UCB (+1 844 599 2273)
17 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Seletracetam (UCB44212) in people with Epilepsy, Partial, run by UCB Pharma SA at 17 sites in 2 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 4 inclusion and 8 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 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 7 Sep 2023). 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?
Percent Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit and Overall by Period (time frame: During the Treatment Period (Week 5 to Week 15), compared to Baseline Period (Week 1 to Week 4)). 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 7 Sep 2023.