Epilepsy, PartialPhase 2NCT00152451
Study With Seletracetam (Ucb 44212) in Adult Subjects (18 to 65 Years) With Partial Onset Seizures
A Phase 2 study testing Seletracetam (ucb 44212) in people with Epilepsy, Partial, run by UCB S.A. - Pharma Sector at 7 sites in United States.
Trial summary
This trial will evaluate the efficacy and safety of ucb 44212 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 (ucb 44212)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 7 sitesUnited States
- Study dates
- 19 May 2005to 3 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 Antiepileptic Drug (AEDs)
- Female subjects without childbearing potential; Female subjects with childbearing potential are eligible if they use a medically accepted non-hormonal 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.
Show all 11Show fewer
- Subjects with clinically significant organ dysfunction
- Known allergic reaction or intolerance to pyrrolidine derivatives and/or excipients
- Pregnant or lactating women
- Subjects currently taking levetiracetam (LEV)
- 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
7 sites in 1 country.
7 sites in 1 country
United States7 sites
N01191 103
Charlottesville, Virginia, 22903
N01191 107
Columbus, Ohio, 43210
N01191 108
Little Rock, Arkansas, 72205
N01191 101
Nashville, Tennessee, 37212
N01191 104
Philadelphia, Pennsylvania, 19104
N01191 105
San Francisco, California, 94115
N01191 102
Stanford, California, 94305
About this study
Official title: An Open-label, Exploratory, Multicenter, Dose-escalation Study Examining the Efficacy, Safety and Tolerability of Ucb 44212 Used at Doses of 10 mg, 20 mg, 40 mg and 80 mg b.i.d. (Total Daily Dose of 20 to 160 mg) in Adult Subjects (18-65 Years) With Refractory Epilepsy Suffering From Partial Onset Seizures (Whether or Not Secondarily Generalized) and Treated With 1, 2 or 3 Approved Antiepileptic Drugs
This trial will evaluate the efficacy and safety of ucb 44212 as add on therapy in subjects with focal epilepsy.
- Conditions
- Epilepsy, Partial
- Being tested
- Seletracetam (ucb 44212)
- Keywords
- Epilepsy, Partial onset seizures, Seletracetam
- 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 (ucb 44212)Drug
- Pharmaceutical form: oral capsules
- Concentration: 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 (ucb 44212) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Change From Baseline in Seizure Frequency Per Week of Partial Onset Seizures (Type I) During the Up-titration Period
Calculated as (7-day seizure frequency during the up-titration 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 duration of the Up-Titration Period was 8 weeks (Visit 3/Week 5 to Visit 7/Week 12).
Measured: During the Up-titration Period (Week 5 to Week 12), compared to Baseline Period (Week 1 to Week 4)
Secondary outcomes (22)
Percentage Change From Baseline in Seizure Frequency Per Week of Partial Onset Seizures (Type I) by Visit Over the Treatment Period (Up-titration + Down-titration)
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)
Percentage Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) Overall in the Down-titration Period
Calculated as (7-day seizure frequency during the down-titration 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 duration of the Down-Titration Period was 3 weeks (Visit 7/Week 13 to Visit 10/Week 15).
Measured: During the Down-Titration Period (Week 13 to Week 15), compared to Baseline Period (Week 1 to Week 4)
Percentage Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I+II+III) by Visit Over the Treatment Period (Up-titration + Down-titration)
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)
Percentage Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I+II+III) Overall in the Up-titration Period
Calculated as (7-day seizure frequency during the up-titration 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 duration of the Up-Titration Period was 8 weeks (Visit 3/Week 5 to Visit 7/Week 12).
Measured: During the Up-Titration Period (Week 5 to Week 12), compared to Baseline Period (Week 1 to Week 4)
Percentage Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I+II+III) Overall in the Down-titration Period
Calculated as (7-day seizure frequency during the down-titration 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 duration of the Down-Titration Period was 3 weeks (Visit 7/Week 13 to Visit 10/Week 15).
Measured: During the Down-Titration Period (Week 13 to Week 15), compared to Baseline Period (Week 1 to Week 4)
Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit Over the Treatment 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 for Partial Onset Seizure (Type I) Overall in the Treatment 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).
Measured: During the Treatment Period (Week 5 to Week 15)
Seizure Frequency Per Week for Partial Onset Seizure (Type I) Overall in the Up-titration Period
Calculated as 7-day partial onset seizure (type I) frequency. The duration of the Up-Titration Period was 8 weeks (Visit 3/Week 5 to Visit 7/Week 12).
Measured: During the Up-Titration Period (Week 5 to Week 12)
Seizure Frequency Per Week for Partial Onset Seizure (Type I) Overall in the Down-titration Period
Calculated as 7-day partial onset seizure (type I) frequency. The duration of the Down-Titration Period was 3 weeks (Visit 7/Week 13 to Visit 10/Week 15).
Measured: During the Down-Titration Period (Week 13 to Week 15)
Seizure Frequency Per Week for All Seizure Types (Type I+II+III) by Visit Over the Treatment 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)
Seizure Frequency Per Week for All Seizure Types (Type I+II+III) Overall in the Treatment 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).
Measured: During the Treatment Period (Week 5 to Week 15)
Seizure Frequency Per Week for All Seizure Types (Type I+II+III) Overall in the Up-titration Period
Calculated as 7-day seizure frequency for all seizure types (type I+II+III). The duration of the Up-Titration Period was 8 weeks (Visit 3/Week 5 to Visit 7/Week 12).
Measured: During the Up-Titration Period (Week 5 to Week 12)
Seizure Frequency Per Week for All Seizure Types (Type I+II+III) Overall in the Down-titration Period
Calculated as 7-day seizure frequency for all seizure types (type I+II+III). The duration of the Down-Titration Period was 3 weeks (Visit 7/Week 13 to Visit 10/Week 15).
Measured: During the Down-Titration Period (Week 13 to Week 15)
Responder Rate 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: Week 12, compared to Baseline Period (Week 1 to Week 4)
Percentage of Participants With Categorized Response to the Treatment in Partial Onset Seizures (Type I) Over the Up-titration Period
Categories of percentage change in seizures from Baseline were as following: < -25%; -25% to <25%; 25% to <75%; 75% to <100%; 100%.
Measured: Week 12, compared to Baseline Period (Week 1 to Week 4)
Percentage 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.
Measured: Week 5 to Week 12, compared to Baseline Period (Week 1 to Week 4)
Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) Overall in the Down-titration Period
Calculated as (7-day seizure frequency during the down-titration period) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)). A negative value in change from Baseline indicates a decrease in partial onset seizure frequency from Baseline. The duration of the Down-Titration Period was 3 weeks (Visit 7/Week 13 to Visit 10/Week 15).
Measured: During the Down-Titration Period (Week 13 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) During the Up-titration Period
Calculated as (7-day seizure frequency during the up-titration period) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)). A negative value in change from Baseline indicates a decrease in partial onset seizure frequency from Baseline. The duration of the Up-Titration Period was 8 weeks (Visit 3/Week 5 to Visit 7/Week 12).
Measured: Week 5 to Week 12, 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) Overall in the Down-titration Period
Calculated as (7-day seizure frequency during the down-titration period) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)). A negative value in change from Baseline indicates a decrease in all seizure types frequency from Baseline. The duration of the Down-Titration Period was 3 weeks (Visit 7/Week 13 to Visit 10/Week 15).
Measured: Week 13 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) Overall in the Up-titration Period
Calculated as (7-day seizure frequency during the up-titration period) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)). A negative value in change from Baseline indicates a decrease in all seizure types frequency from Baseline. The duration of the Up-Titration Period was 8 weeks (Visit 3/Week 5 to Visit 7/Week 12).
Measured: Week 5 to Week 12, 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 Over the Treatment Period (Up-titration + Down-titration)
Calculated as (7-day seizure frequency during the treatment period for visit n) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)). The treatment period referred to includes the period from the previous visit n-1 up to but not including the specific visit n. A negative value in change from Baseline indicates a decrease in partial onset seizure frequency from Baseline. The Overall 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).
Measured: 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 Over the Treatment Period (Up-titration + Down-titration)
Calculated as (7-day seizure frequency during the treatment period for visit n) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)). The treatment period referred to includes the period from the previous visit n-1 up to but not including the specific visit n. A negative value in change from Baseline indicates a decrease in all seizure types frequency from Baseline. The Overall 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).
Measured: Week 5 to Week 15, 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 start19 May 2005
- Primary completion3 May 2006
- Study completion3 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB S.A. - Pharma Sector
- 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
- NCT00152451
- Sponsor's protocol ID
- N01191
- Status last verified
- Sep 2023
- First submitted
- 7 Sep 2005
- Last updated
- 29 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Exploratory, Multicenter, Dose-escalation Study Examining the Efficacy, Safety and Tolerability of Ucb 44212 Used at Doses of 10 mg, 20 mg, 40 mg and 80 mg b.i.d. (Total Daily Dose of 20 to 160 mg) in Adult Subjects (18-65 Years) With Refractory Epilepsy Suffering From Partial Onset Seizures (Whether or Not Secondarily Generalized) and Treated With 1, 2 or 3 Approved Antiepileptic Drugs
- ClinicalTrials.gov ID
- NCT00152451
- Acronym / sponsor ID
- N01191
- Conditions
- Epilepsy, Partial
- Keywords
- Epilepsy, Partial onset seizures, Seletracetam
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- UCB S.A. - Pharma SectorIndustry (pharma, biotech, devices)
- Study start
- 19 May 2005 (actual)
- Primary completion
- 3 May 2006 (actual)
- Study completion
- 3 May 2006 (actual)
- First posted
- 9 Sep 2005 (estimated)
- Results
- Posted 29 Mar 2024
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 ucb 44212 as add on therapy in subjects with focal epilepsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Seletracetam | Experimental | Drug: Seletracetam (ucb 44212)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 Antiepileptic Drug (AEDs)
- Female subjects without childbearing potential; Female subjects with childbearing potential are eligible if they use a medically accepted non-hormonal contraceptive method
Key exclusion criteria (11 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
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 (ucb 44212)* Pharmaceutical form: oral capsules * Concentration: 10 and 50 mg * Route of administration: oral administration | Drug | Seletracetam |
Primary outcome
Percentage Change From Baseline in Seizure Frequency Per Week of Partial Onset Seizures (Type I) During 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)
Calculated as (7-day seizure frequency during the up-titration 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 duration of the Up-Titration Period was 8 weeks (Visit 3/Week 5 to Visit 7/Week 12).
22 secondary outcomes
Percentage Change From Baseline in Seizure Frequency Per Week of Partial Onset Seizures (Type I) by Visit Over the Treatment Period (Up-titration + Down-titration)
Time frame: During the Treatment Period (Week 5 to Week 15), compared to Baseline Period (Week 1 to Week 4)
Percentage Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) Overall in the Down-titration Period
Time frame: During the Down-Titration Period (Week 13 to Week 15), compared to Baseline Period (Week 1 to Week 4)
Percentage Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I+II+III) by Visit Over the Treatment Period (Up-titration + Down-titration)
Time frame: During the Treatment Period (Week 5 to Week 15), compared to Baseline Period (Week 1 to Week 4)
Percentage Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I+II+III) Overall in 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)
Percentage Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I+II+III) Overall in the Down-titration Period
Time frame: During the Down-Titration Period (Week 13 to Week 15), compared to Baseline Period (Week 1 to Week 4)
Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit Over the Treatment Period
Time frame: During the Treatment Period (Week 5 to Week 15)
Seizure Frequency Per Week for Partial Onset Seizure (Type I) Overall in the Treatment Period
Time frame: During the Treatment Period (Week 5 to Week 15)
Seizure Frequency Per Week for Partial Onset Seizure (Type I) Overall in the Up-titration Period
Time frame: During the Up-Titration Period (Week 5 to Week 12)
Seizure Frequency Per Week for Partial Onset Seizure (Type I) Overall in the Down-titration Period
Time frame: During the Down-Titration Period (Week 13 to Week 15)
Seizure Frequency Per Week for All Seizure Types (Type I+II+III) by Visit Over the Treatment Period
Time frame: During the Treatment Period (Week 5 to Week 15)
Seizure Frequency Per Week for All Seizure Types (Type I+II+III) Overall in the Treatment Period
Time frame: During the Treatment Period (Week 5 to Week 15)
Seizure Frequency Per Week for All Seizure Types (Type I+II+III) Overall in the Up-titration Period
Time frame: During the Up-Titration Period (Week 5 to Week 12)
Seizure Frequency Per Week for All Seizure Types (Type I+II+III) Overall in the Down-titration Period
Time frame: During the Down-Titration Period (Week 13 to Week 15)
Responder Rate in Partial Onset Seizures (Type I) Over the Up-titration Period
Time frame: Week 12, compared to Baseline Period (Week 1 to Week 4)
Percentage of Participants With Categorized Response to the Treatment in Partial Onset Seizures (Type I) Over the Up-titration Period
Time frame: Week 12, compared to Baseline Period (Week 1 to Week 4)
Percentage Change From Baseline in Seizure-free Days Per Week Over the Up-titration Period
Time frame: Week 5 to Week 12, compared to Baseline Period (Week 1 to Week 4)
Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) Overall in the Down-titration Period
Time frame: During the Down-Titration Period (Week 13 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) During the Up-titration Period
Time frame: Week 5 to Week 12, 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) Overall in the Down-titration Period
Time frame: Week 13 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) Overall in the Up-titration Period
Time frame: Week 5 to Week 12, 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 Over the Treatment Period (Up-titration + Down-titration)
Time frame: 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 Over the Treatment Period (Up-titration + Down-titration)
Time frame: Week 5 to Week 15, 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 29 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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 Cares study director
UCB (+1 844 599 2273)
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Seletracetam (ucb 44212) in people with Epilepsy, Partial, run by UCB S.A. - Pharma Sector at 7 sites in United States.
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 11 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 29 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. 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 29 Mar 2024). 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 Change From Baseline in Seizure Frequency Per Week of Partial Onset Seizures (Type I) During 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)). 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 29 Mar 2024.