EpilepsyPhase 3BRITE™NCT01339559
Brivaracetam Safety and Efficacy Follow-up Study in Subjects With Epilepsy
A Phase 3 study testing Brivaracetam in people with Epilepsy, run by UCB BIOSCIENCES, Inc. at 184 sites in 28 countries.
Trial summary
This is a Phase 3, open label, long term follow-up (LTFU), multicenter, noncomparative, and single arm study of brivaracetam (BRV). Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- Brivaracetam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 767 participants
- Where
- 184 sitesin 28 countries
- Study dates
- 11 May 2011to 18 Apr 2019
- 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 completed the Treatment Period of N01358 or the evaluation period of N01258
- Male/female subject from 16 years or older. Subject under 18 years may only be included where legally permitted and ethically accepted
- Subject for whom the Investigator believes a reasonable benefit from the long term administration of BRV may be expected
- Female subject without childbearing potential (premenarcheal, postmenopausal for at least 2 years, bilateral oophorectomy or tubal ligation, complete hysterectomy) are eligible
Who cannot join
- Subject has developed hypersensitivity to any components of the investigational medicinal product (IMP) or comparative drugs as stated in this protocol during the course of the core studies
- Severe medical, neurological, or psychiatric disorders, or laboratory values which may have an impact on the safety of the subject
- Poor compliance with the visit schedule or medication intake in the previous BRV study
- Planned participation in any other clinical study of another investigational drug or device during this study
- Pregnant or lactating woman
- Any medical condition which, in the Investigator's opinion, warrants exclusion
- Subject has a lifetime history of suicide attempt or has suicidal ideation in the past 6 months
Trial locations and contacts
184 sites in 28 countries.
184 sites in 28 countries
United States49 sites
020
Ames, Iowa, 50010
010
Asheville, North Carolina, 28806
023
Atlanta, Georgia, 30322
060
Aurora, Colorado, 80045
061
Austin, Texas, 78758
008
Bethesda, Maryland, 20817
039
Boise, Idaho, 83702
028
Charleston, South Carolina, 29425
036
Charlottesville, Virginia, 22908
029
Chicago, Illinois, 60612
034
Cleveland, Ohio, 44195
778
Columbus, Ohio, 43210
070
Columbus, Ohio, 43215
011
Dallas, Texas, 75251
777
Dallas, Texas, 75251
035
Dallas, Texas, 75390
003
Durham, North Carolina, 27705
009
Golden Valley, Minnesota, 55422
042
Hamilton, New Jersey, 08619
049
Houston, Texas, 77025
069
Iowa City, Iowa, 52242
032
Lebanon, New Hampshire, 03756
780
Lexington, Kentucky, 40536
775
Little Rock, Arkansas, 72205
052
Madison, Wisconsin, 53715
050
Mansfield, Texas, 76063
071
Miami, Florida, 33176
057
Milwaukee, Wisconsin, 53215
776
Nashville, Tennessee, 37232-25
099
New York, New York, 10011
022
New York, New York, 10016
043
Oklahoma City, Oklahoma, 73112
091
Oklahoma City, Oklahoma, 73112
027
Orlando, Florida, 32819
005
Peoria, Illinois, 61637
015
Philadelphia, Pennsylvania, 19107
001
Phoenix, Arizona, 85004
013
Phoenix, Arizona, 85006
064
Port Charlotte, Florida, 33952
021
Port Royal, South Carolina, 29965
098
Poughkeepsie, New York, 12601
048
Rome, Georgia, 30165
025
San Francisco, California, 94115
056
Spokane, Washington, 99204
002
Toledo, Ohio, 43614
006
Tucson, Arizona, 85718
054
Tulsa, Oklahoma, 74136-83
068
Waldorf, Maryland, 20603
017
Winfield, Illinois, 60190
Poland15 sites
475
Bialystok
485
Gdansk
791
Gdansk
478
Katowice
480
Katowice
481
Katowice
795
Katowice
476
Krakow
793
Krakow
483
Lublin
477
Poznan
479
Poznan
482
Poznan
488
Warsaw
794
Warsaw
Germany11 sites
329
Berlin
326
Bernau
332
Bielefeld
902
Erlangen
331
Göttingen
327
Kiel
900
Marburg
335
München
334
Osnabrück
330
Ravensburg
328
Ulm
Italy9 sites
378
Bari
380
Florence
379
Milan
377
Monserrato
386
Naples
376
Perugia
375
Pisa
383
Pozzilli
384
Reggio Calabria
Spain9 sites
528
Barcelona
529
Barcelona
535
Barcelona
540
Barcelona
539
Donostia / San Sebastian
532
Santiago de Compostela
527
Valencia
537
Valencia
526
Valladolid
Czechia8 sites
917
Brno
916
Kroměříž
251
Ostrava
256
Ostrava
913
Ostrava Poruba
252
Prague
253
Prague
250
Zlín
United Kingdom7 sites
603
Birmingham
600
London
605
Middlesbrough
602
Morriston, Swansea
607
Newcastle
608
Salford
601
Truro
Canada6 sites
075
Calgary, Alberta
077
Greenfield Park, Quebec
078
London, Ontario
079
Montreal
080
Saskatoon, Saskatchewan
076
Toronto, Ontario
India6 sites
726
Bangalore
727
Hyderabad
729
Madurai
725
Mumbai
728
Mumbai
731
Nashik, Maharashtra
Mexico6 sites
129
Aguascalientes
127
Culiacán
125
Distrito Federal
126
Guadalajara, Jalisco
128
Guadalajara, Jalisco
130
Mexico City
Russia6 sites
501
Kazan'
506
Kazan'
502
Moscow
503
Moscow
509
Nizhny Novgorod
508
Smolensk
Hungary5 sites
410
Budapest
411
Budapest
412
Budapest
414
Hajdú-Bihar
413
Szekszárd
About this study
Official title: An Open-label, Multicenter, Follow-up Study to Evaluate the Long-term Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment in Subjects Aged 16 Years or Older With Epilepsy
This is a Phase 3, open label, long term follow-up (LTFU), multicenter, noncomparative, and single arm study of brivaracetam (BRV).
Read the detailed description
The primary objective is to evaluate the long term safety and tolerability of BRV at individualized doses up to a maximum of 200 mg/day in epilepsy subjects.
- Conditions
- Epilepsy
- Being tested
- Brivaracetam
- Keywords
- Epilepsy, Brivaracetam, Partial Onset Seizures, Adjunctive treatment
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrivaracetamDrug
Also called UCB34714
Tablet, Flexible dosing up to 200 mg/day, twice daily.
The study will continue until either regulatory approval of brivaracetam has been granted by any Health Authority in an indication of adjunctive treatment of partial onset seizures or until the Sponsor decides to close the study, or until the investigational product development is stopped by the Sponsor.
| Study group | Role | What they receive |
|---|---|---|
| Brivaracetam | Experimental | Brivaracetam with a maximum of 200 mg/day Receives: Drug: Brivaracetam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)
Treatment-emergent Adverse Events (TEAEs) were defined as those events which started on or after the date of first dose of investigational medicinal product (IMP), or events in which severity worsened on or after the date of first dose of study medication. The event does not necessarily have a causal relationship with that treatment or usage.
Measured: From Entry Visit (Month 0) until the Last Visit (up to 84 months)
Percentage of Participants Who Withdrew Due to Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage.
Measured: From Entry Visit (Month 0) until the Last Visit (up to 84 months)
Percentage of Participants With at Least One Serious Adverse Event (SAE)
A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose:
- Results in death
- Is life-threatening
- Requires in patient hospitalization or prolongation of existing hospitalization
- Is a congenital anomaly or birth defect
- Is as infection that requires treatment parenteral antibiotics
- Other important medical events which based on medical or scientific judgement may jeopardize the patients or may require medical or surgical intervention to prevent any of the above.
Measured: From Entry Visit (Month 0) until the Last Visit (up to 84 months)
Secondary outcomes (3)
Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days During the Evaluation Period
The 28 day adjusted seizure frequency was calculated by dividing the number of partial seizures by the number of days for which the diary was completed, and multiplying the resulting value by 28.
Measured: From Baseline of the previous study until the Last Visit (up to 84 months)
Percent Change in Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days From Baseline of the Previous Study to the Evaluation Period
The percent change from the previous study baselines, in Partial Onset Seizure (POS) (Type I) frequency per 28 days is defined as:
(the value at the previous study baselines) minus (the value at each time-points during the evaluation period) divided by the value at the previous study baselines.
Note: Since N01258 was a safety study, participants were not required to meet seizure frequency requirements during the Baseline Period, and the Baseline Period was short (ie, 7 days). Therefore, participants from N01258 were excluded from efficacy summaries in the variable of percent change in POS frequency.
Measured: From Baseline of the previous study until the Last Visit (up to 84 months)
Responder Rate in POS (Type I) Frequency Over the Evaluation Period
A responder is defined as a subject with a ≥ 50% reduction in seizure frequency from the Baseline Period of the previous study.
Note: Since N01258 was a safety study, participants were not required to meet seizure frequency requirements during the Baseline Period, and the Baseline Period was short (ie, 7 days). Therefore, participants from N01258 were excluded from efficacy summaries in the variable of responder rates in POS frequency.
Measured: From Baseline of the previous study until the Last Visit (up to 84 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2011 (estimated)
- Study start11 May 2011
- Primary completion18 Apr 2019
- Study completion18 Apr 2019
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.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- 767 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB BIOSCIENCES, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Cares, Study director, +1 844 599 2273 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01339559
- Sponsor's protocol ID
- N01379
- Other IDs
- 2010-020345-27
- Acronym
- BRITE™
- Status last verified
- Aug 2021
- First submitted
- 19 Apr 2011
- Last updated
- 17 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Expanded access
- Available
Publications
Moseley BD, Dimova S, Elmoufti S, Laloyaux C, Asadi-Pooya AA. Long-term efficacy and tolerability of adjunctive brivaracetam in adults with focal to bilateral tonic-clonic (secondary generalized) seizures: Post hoc pooled analysis. Epilepsy Res. 2021 Oct;176:106694. doi: 10.1016/j.eplepsyres.2021.106694. Epub 2021 Jun 24.
PubMed 34218211Brandt C, Dimova S, Elmoufti S, Laloyaux C, Nondonfaz X, Klein P. Retention, efficacy, tolerability, and quality of life during long-term adjunctive brivaracetam treatment by number of lifetime antiseizure medications: A post hoc analysis of phase 3 trials in adults with focal seizures. Epilepsy Behav. 2023 Jan;138:108967. doi: 10.1016/j.yebeh.2022.108967. Epub 2022 Nov 23.
PubMed 36435010Markham A. Brivaracetam: First Global Approval. Drugs. 2016 Mar;76(4):517-22. doi: 10.1007/s40265-016-0555-6.
PubMed 26899665Klein P, Schiemann J, Sperling MR, Whitesides J, Liang W, Stalvey T, Brandt C, Kwan P. A randomized, double-blind, placebo-controlled, multicenter, parallel-group study to evaluate the efficacy and safety of adjunctive brivaracetam in adult patients with uncontrolled partial-onset seizures. Epilepsia. 2015 Dec;56(12):1890-8. doi: 10.1111/epi.13212. Epub 2015 Oct 16.
PubMed 26471380
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter, Follow-up Study to Evaluate the Long-term Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment in Subjects Aged 16 Years or Older With Epilepsy
- ClinicalTrials.gov ID
- NCT01339559
- Acronym / sponsor ID
- BRITE™ / N01379
- Conditions
- Epilepsy
- Keywords
- Epilepsy, Brivaracetam, Partial Onset Seizures, Adjunctive treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 767 participants (actual)
- Lead sponsor
- UCB BIOSCIENCES, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 May 2011 (actual)
- Primary completion
- 18 Apr 2019 (actual)
- Study completion
- 18 Apr 2019 (actual)
- First posted
- 20 Apr 2011 (estimated)
- Results
- Posted 4 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 3, open label, long term follow-up (LTFU), multicenter, noncomparative, and single arm study of brivaracetam (BRV).
Detailed description
The primary objective is to evaluate the long term safety and tolerability of BRV at individualized doses up to a maximum of 200 mg/day in epilepsy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brivaracetam | Experimental | Drug: BrivaracetamBrivaracetam with a maximum of 200 mg/day |
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 completed the Treatment Period of N01358 or the evaluation period of N01258
- Male/female subject from 16 years or older. Subject under 18 years may only be included where legally permitted and ethically accepted
- Subject for whom the Investigator believes a reasonable benefit from the long term administration of BRV may be expected
- Female subject without childbearing potential (premenarcheal, postmenopausal for at least 2 years, bilateral oophorectomy or tubal ligation, complete hysterectomy) are eligible
Key exclusion criteria (7 listed)
- Subject has developed hypersensitivity to any components of the investigational medicinal product (IMP) or comparative drugs as stated in this protocol during the course of the core studies
- Severe medical, neurological, or psychiatric disorders, or laboratory values which may have an impact on the safety of the subject
- Poor compliance with the visit schedule or medication intake in the previous BRV study
- Planned participation in any other clinical study of another investigational drug or device during this study
- Pregnant or lactating woman
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 |
|---|---|---|
| BrivaracetamAlso: UCB34714Tablet, Flexible dosing up to 200 mg/day, twice daily. The study will continue until either regulatory approval of brivaracetam has been granted by any Health Authority in an indication of adjunctive treatment of partial onset seizures or until the Sponsor decides to close the study, or until the investigational product development is stopped by the Sponsor. | Drug | Brivaracetam |
Primary outcome
Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)
Time frame: From Entry Visit (Month 0) until the Last Visit (up to 84 months)
Treatment-emergent Adverse Events (TEAEs) were defined as those events which started on or after the date of first dose of investigational medicinal product (IMP), or events in which severity worsened on or after the date of first dose of study medication. The event does not necessarily have a causal relationship with that treatment or usage.
Percentage of Participants Who Withdrew Due to Adverse Events (AEs)
Time frame: From Entry Visit (Month 0) until the Last Visit (up to 84 months)
An AE is any untoward medical occurrence in a participant or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage.
Percentage of Participants With at Least One Serious Adverse Event (SAE)
Time frame: From Entry Visit (Month 0) until the Last Visit (up to 84 months)
A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: * Results in death * Is life-threatening * Requires in patient hospitalization or prolongation of existing hospitalization * Is a congenital anomaly or birth defect * Is as infection that requires treatment parenteral antibiotics * Other important medical events which based on medical or scientific judgement may jeopardize the patients or may require medical or surgical intervention to prevent any of the above.
3 secondary outcomes
Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days During the Evaluation Period
Time frame: From Baseline of the previous study until the Last Visit (up to 84 months)
Percent Change in Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days From Baseline of the Previous Study to the Evaluation Period
Time frame: From Baseline of the previous study until the Last Visit (up to 84 months)
Responder Rate in POS (Type I) Frequency Over the Evaluation Period
Time frame: From Baseline of the previous study until the Last Visit (up to 84 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 34218211Moseley BD, Dimova S, Elmoufti S, Laloyaux C, Asadi-Pooya AA. Long-term efficacy and tolerability of adjunctive brivaracetam in adults with focal to bilateral tonic-clonic (secondary generalized) seizures: Post hoc pooled analysis. Epilepsy Res. 2021 Oct;176:106694. doi: 10.1016/j.eplepsyres.2021.106694. Epub 2021 Jun 24.
- Derived from this study: PubMed 36435010Brandt C, Dimova S, Elmoufti S, Laloyaux C, Nondonfaz X, Klein P. Retention, efficacy, tolerability, and quality of life during long-term adjunctive brivaracetam treatment by number of lifetime antiseizure medications: A post hoc analysis of phase 3 trials in adults with focal seizures. Epilepsy Behav. 2023 Jan;138:108967. doi: 10.1016/j.yebeh.2022.108967. Epub 2022 Nov 23.
- Derived from this study: PubMed 26899665Markham A. Brivaracetam: First Global Approval. Drugs. 2016 Mar;76(4):517-22. doi: 10.1007/s40265-016-0555-6.
- Derived from this study: PubMed 26471380Klein P, Schiemann J, Sperling MR, Whitesides J, Liang W, Stalvey T, Brandt C, Kwan P. A randomized, double-blind, placebo-controlled, multicenter, parallel-group study to evaluate the efficacy and safety of adjunctive brivaracetam in adult patients with uncontrolled partial-onset seizures. Epilepsia. 2015 Dec;56(12):1890-8. doi: 10.1111/epi.13212. Epub 2015 Oct 16.
- Product InformationLink provided by the sponsor.
- 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 Cares study director
+1 844 599 2273 (UCB)
184 sites in 28 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Brivaracetam in people with Epilepsy, run by UCB BIOSCIENCES, Inc. at 184 sites in 28 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 7 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 17 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 184 sites in United States, Poland, Germany, Italy, Spain and 23 more countries. 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 4 Jun 2020). 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 Participants With at Least One Treatment-Emergent Adverse Event (TEAE) (time frame: From Entry Visit (Month 0) until the Last Visit (up to 84 months)). 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?
On the ClinicalTrials.gov record for NCT01339559, which also lists 4 linked publications.
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 17 Aug 2021.