EpilepsyPhase 3BRITENCT01261325
Brivaracetam Efficacy and Safety Study in Subjects With Partial Onset Seizures
A Phase 3 study testing Brivaracetam and Antiepileptic drugs with market authorization available per country in people with Epilepsy, run by UCB Pharma at 207 sites in 28 countries.
Trial summary
This study will evaluate the efficacy and safety of brivaracetam at doses of 100 and 200mg/day compared to placebo as adjunctive treatment in adult focal epilepsy subjects with partial onset seizures not fully controlled despite current treatment with 1 or 2 concomitant antiepileptic drugs. Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Brivaracetam and Antiepileptic drugs with market authorization available per country
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 768 participants
- Where
- 207 sitesin 28 countries
- Study dates
- Dec 2010to May 2014
- 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 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Well-characterized focal epilepsy/epileptic syndrome according to the 1989 International League Against Epilepsy (ILAE) classification
- Presence of an EEG reading compatible with the clinical diagnosis of focal epilepsy within the last 5 years
- Presence of a brain MRI/computed tomography (CT) scan performed within the last 2 years
- Subjects having at least 8 Type I seizures [POS; focal seizures (according to the 1981 ILAE classification)] during the 8-week Baseline Period with at least 2 Type I seizures during each 4-week interval of the Baseline Period
- Subjects having at least 2 partial onset seizures whether or not secondarily generalized per month during the 3 months preceding V1
- Subjects being uncontrolled while treated by 1 or 2 permitted concomitant AED(s). Vagal Nerve Stimulation (VNS) is allowed and will be counted as a concomitant AED
- Permitted concomitant AED(s) and VNS being stable and at optimal dosage for the subject from at least 1 month (3 months for phenobarbital, phenytoin, and primidone) before V1 and expected to be kept stable during the Baseline and Treatment Period. Benzodiazepine taken more than once a week (for any indication) will be considered as a concomitant AED
Who cannot join
- Subject previously randomized within this study or any other prior study with BRV as a dosing arm
- Seizure type IA (1981 ILAE classification) nonmotor as only seizure type.
- Subject is currently treated with LEV or has taken LEV within 90 days prior to V1
- Subject has any medical or psychiatric condition, obvious cognitive impairment or mental retardation that, in the opinion of the Investigator, could jeopardize or would compromise the subject's ability to participate in this study
- Subjects whose seizures could not be reliably counted on a regular basis due to their fast and repetitive occurrence (clusters or flurries)
- Subject has history or presence of status epilepticus during the year preceding V1 or during Baseline
Show all 14Show fewer
- Subject has history or presence of known psychogenic nonepileptic seizures
- Subject on felbamate with less than 18 months exposure before V1
- Subject currently on vigabatrin. Subject with history of vigabatrin use but either no visual fields examination report available including standard static (Humphrey or Octopus) or kinetic perimetry (Goldman) or results of these examinations are abnormal
- Subject taking any drug with possible central nervous system (CNS) effects except if stable from at least 1 month before V1 and expected to be kept stable during the Treatment Period
- Subject has history of cerebrovascular accident, including transient ischemic attack, in the last 6 months
- Subject is suffering from severe cardiovascular disease or peripheral vascular disease
- Subject has a lifetime history of suicide attempt or has suicidal ideation in the past 6 months
- Subject has ongoing psychiatric disease other than mild controlled disorder
Trial locations and contacts
207 sites in 28 countries.
207 sites in 28 countries
United States61 sites
020
Ames, Iowa
050
Arlington, Texas
010
Asheville, North Carolina
023
Atlanta, Georgia
063
Atlanta, Georgia
060
Aurora, Colorado
061
Austin, Texas
008
Bethesda, Maryland
039
Boise, Idaho
096
Canton, Ohio
089
Casper, Wyoming
028
Charleston, South Carolina
036
Charlottesville, Virginia
034
Cleveland, Ohio
085
Colorado Springs, Colorado
062
Columbus, Georgia
070
Columbus, Ohio
011
Dallas, Texas
035
Dallas, Texas
003
Durham, North Carolina
055
East Lansing, Michigan
009
Golden Valley, Minnesota
042
Hamilton, New Jersey
092
Hammond, Louisiana
049
Houston, Texas
069
Iowa City, Iowa
095
Kingston, New York
032
Lebanon, New Hampshire
780
Lexington, Kentucky
775
Little Rock, Arkansas
052
Madison, Wisconsin
071
Miami, Florida
110
Miami, Florida
057
Milwaukee, Wisconsin
051
Missoula, Montana
073
Naples, Florida
022
New York, New York
099
New York, New York
090
Ocala, Florida
043
Oklahoma City, Oklahoma
091
Oklahoma City, Oklahoma
027
Orlando, Florida
005
Peoria, Illinois
015
Philadelphia, Pennsylvania
001
Phoenix, Arizona
013
Phoenix, Arizona
064
Port Charlotte, Florida
021
Port Royal, South Carolina
098
Poughkeepsie, New York
048
Rome, Georgia
045
Sacramento, California
025
San Francisco, California
044
Sarasota, Florida
033
Seattle, Washington
056
Spokane, Washington
002
Toledo, Ohio
006
Tucson, Arizona
054
Tulsa, Oklahoma
058
Voorhees Township, New Jersey
068
Waldorf, Maryland
017
Winfield, Illinois
Poland13 sites
475
Bialystok
485
Gdansk
791
Gdansk
478
Katowice
480
Katowice
481
Katowice
476
Krakow
793
Krakow
483
Lublin
477
Poznan
479
Poznan
482
Poznan
488
Warsaw
Germany12 sites
329
Berlin
326
Bernau
332
Bielefeld
902
Erlangen
331
Göttingen
904
Kehl-Kork
327
Kiel
900
Marburg
335
München
334
Osnabrück
330
Ravensburg
328
Ulm
Italy10 sites
378
Bari
380
Florence
379
Milan
377
Monserrato, Cagliari
386
Naples
376
Perugia
375
Pisa
383
Pozzilli
384
Reggio Calabria
382
Torino
Spain10 sites
536
Badalona
528
Barcelona
529
Barcelona
535
Barcelona
540
Barcelona
539
Donostia / San Sebastian
532
Santiago de Compostela
527
Valencia
537
Valencia
526
Valladolid
United Kingdom8 sites
603
Birmingham
606
Cardiff
601
Cornwall
600
London
605
Middlesbrough
607
Newcastle
608
Salford
602
Swansea
Czechia7 sites
916
Kroměříž
251
Ostrava
256
Ostrava
913
Ostrava Poruba
252
Prague
253
Prague
250
Zlín
Russia7 sites
501
Kazan'
506
Kazan'
502
Moscow
503
Moscow
505
Moscow
509
Nizhny Novgorod
508
Smolensk
Canada6 sites
075
Calgary, Alberta
077
Greenfield Park, Quebec
078
London, Ontario
079
Montreal, Quebec
080
Saskatoon, Saskatchewan
076
Toronto, Ontario
India6 sites
726
Bangalore
727
Hyderabad, Andhra Pradesh
729
Madurai
725
Mumbai, Maharashtra
728
Mumbai, Maharashtra
731
Nashik, Maharashtra
Mexico6 sites
129
Aguascalientes
127
Culiacán
125
Distrito Federal
126
Guadalajara, Jalisco
128
Guadalajara, Jalisco
130
Mexico City
Brazil4 sites
104
Belo Horizonte
100
Florianópolis
103
Riberao Preto
101
São Paulo
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study to Evaluate the Efficacy and Safety of Brivaracetam in Subjects (≥16 to 80 Years Old) With Partial Onset Seizures
This study will evaluate the efficacy and safety of brivaracetam at doses of 100 and 200mg/day compared to placebo as adjunctive treatment in adult focal epilepsy subjects with partial onset seizures not fully controlled despite current treatment with 1 or 2 concomitant antiepileptic drugs.
- Conditions
- Epilepsy
- Being tested
- Placebo, Brivaracetam, Antiepileptic drugs with market authorization available per country
- 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.
PlaceboDrug
Daily oral dose of two equal intakes of placebo in a double-blinded way for the 12-week treatment period
BrivaracetamDrug
Daily oral dose of two equal intakes of Brivaracetam 100 mg/ day in a double-blinded way for the 12-week treatment period
BrivaracetamDrug
Daily oral dose of two equal intakes of Brivaracetam 200 mg/ day in a double-blinded way for the 12-week treatment period.
Antiepileptic drugs with market authorization available per countryDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Matching placebo tablets administered twice daily Receives: Drug: Placebo; Drug: Antiepileptic drugs with market authorization available per country |
| Brivaracetam 100 mg/ day | Experimental | Brivaracetam 50 mg/ day administered twice daily. Receives: Drug: Brivaracetam; Drug: Antiepileptic drugs with market authorization available per country |
| Brivaracetam 200 mg/ day | Experimental | Brivaracetam 100 mg/ day administered twice daily Receives: Drug: Brivaracetam; Drug: Antiepileptic drugs with market authorization available per country |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Reduction Over Placebo for Partial Onset Seizure (Type I) Frequency Over the Treatment Period Standardized to a 28-day Duration
Primary endpoint: United States of America (FDA)
Measured: 12 week Treatment Period
50% Responder Rate for Partial Onset Seizure (Type I) Frequency Over the Treatment Period Standardized to a 28-day Duration
Primary Endpoint: European Regulatory Authorities A responder is a participant who experienced a 50% or greater reduction in partial onset seizure (Type I) frequency over the Treatment Period standardized to a 28-day duration.
Measured: Baseline to 12 week Treatment Period
Secondary outcomes (7)
Percent Change in Partial Onset Seizure (Type I) Frequency From the Baseline to the Treatment Period
Measured: Baseline to 12 week Treatment Period
Categorized Percent Reduction Form Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the Treatment Period
Measured: Baseline to 12 week Treatment Period
Seizure Freedom Rate (All Seizure Types) During the 12-week Treatment Period
Measured: 12 week Treatment Period
All Seizure Frequency (Type I + II + III) During the 12-week Treatment Period
Measured: 12 week Treatment Period
Time to the First Type I Seizure During the Treatment Period
Measured: 12 week Treatment Period
Time to the Fifth Type I Seizure During the Treatment Period
Measured: 12 week Treatment Period
Time to the Tenth Type I Seizure During the Treatment Period
Measured: 12 week Treatment Period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionMay 2014
- Study completionMay 2014
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 (19)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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 768 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Clinical Trial Call Center, Study director, +1 877 822 9493 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01261325
- Sponsor's protocol ID
- N01358
- Other IDs
- 2010-019361-28
- Acronym
- BRITE
- Status last verified
- Jul 2022
- First submitted
- 9 Dec 2010
- Last updated
- 22 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Expanded access
- Available
Publications
Toledo M, Whitesides J, Schiemann J, Johnson ME, Eckhardt K, McDonough B, Borghs S, Kwan P. Safety, tolerability, and seizure control during long-term treatment with adjunctive brivaracetam for partial-onset seizures. Epilepsia. 2016 Jul;57(7):1139-51. doi: 10.1111/epi.13416. Epub 2016 Jun 6.
PubMed 27265725Ben-Menachem E, Mameniskiene R, Quarato PP, Klein P, Gamage J, Schiemann J, Johnson ME, Whitesides J, McDonough B, Eckhardt K. Efficacy and safety of brivaracetam for partial-onset seizures in 3 pooled clinical studies. Neurology. 2016 Jul 19;87(3):314-23. doi: 10.1212/WNL.0000000000002864. Epub 2016 Jun 22.
PubMed 27335114Klein 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 26471380Brodie MJ, Whitesides J, Schiemann J, D'Souza J, Johnson ME. Tolerability, safety, and efficacy of adjunctive brivaracetam for focal seizures in older patients: A pooled analysis from three phase III studies. Epilepsy Res. 2016 Nov;127:114-118. doi: 10.1016/j.eplepsyres.2016.08.018. Epub 2016 Aug 18.
PubMed 27589414Moseley BD, Sperling MR, Asadi-Pooya AA, Diaz A, Elmouft S, Schiemann J, Whitesides J. Efficacy, safety, and tolerability of adjunctive brivaracetam for secondarily generalized tonic-clonic seizures: Pooled results from three Phase III studies. Epilepsy Res. 2016 Nov;127:179-185. doi: 10.1016/j.eplepsyres.2016.09.003. Epub 2016 Sep 3.
PubMed 27608437Brandt C, Borghs S, Elmoufti S, Mueller K, Townsend R, de la Loge C. Health-related quality of life in double-blind Phase III studies of brivaracetam as adjunctive therapy of focal seizures: A pooled, post-hoc analysis. Epilepsy Behav. 2017 Apr;69:80-85. doi: 10.1016/j.yebeh.2016.11.031. Epub 2017 Feb 23.
PubMed 28236727Klein P, Johnson ME, Schiemann J, Whitesides J. Time to onset of sustained >/=50% responder status in patients with focal (partial-onset) seizures in three phase III studies of adjunctive brivaracetam treatment. Epilepsia. 2017 Feb;58(2):e21-e25. doi: 10.1111/epi.13631. Epub 2016 Dec 18.
PubMed 27988967Asadi-Pooya AA, Sperling MR, Chung S, Klein P, Diaz A, Elmoufti S, Schiemann J, Whitesides J. Efficacy and tolerability of adjunctive brivaracetam in patients with prior antiepileptic drug exposure: A post-hoc study. Epilepsy Res. 2017 Mar;131:70-75. doi: 10.1016/j.eplepsyres.2017.02.007. Epub 2017 Feb 27.
PubMed 28279891Benbadis S, Klein P, Schiemann J, Diaz A, Elmoufti S, Whitesides J. Efficacy, safety, and tolerability of brivaracetam with concomitant lamotrigine or concomitant topiramate in pooled Phase III randomized, double-blind trials: A post-hoc analysis. Epilepsy Behav. 2018 Mar;80:129-134. doi: 10.1016/j.yebeh.2017.12.024. Epub 2018 Feb 3.
PubMed 29414542Brodie MJ, Fakhoury T, McDonough B, Colson AO, Stockis A, Elmoufti S, Whitesides J. Brivaracetam-induced elevation of carbamazepine epoxide levels: A post-hoc analysis from the clinical development program. Epilepsy Res. 2018 Sep;145:55-62. doi: 10.1016/j.eplepsyres.2018.06.002. Epub 2018 Jun 4.
PubMed 29908435Klein P, Laloyaux C, Elmoufti S, Gasalla T, Martin MS. Time course of 75%-100% efficacy response of adjunctive brivaracetam. Acta Neurol Scand. 2020 Aug;142(2):175-180. doi: 10.1111/ane.13287. Epub 2020 Jun 9.
PubMed 32432339Moseley 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 34218211Ryvlin P, Dimova S, Elmoufti S, Floricel F, Laloyaux C, Nondonfaz X, Biton V. Tolerability and efficacy of adjunctive brivaracetam in adults with focal seizures by concomitant antiseizure medication use: Pooled results from three phase 3 trials. Epilepsia. 2022 Aug;63(8):2024-2036. doi: 10.1111/epi.17304. Epub 2022 Jun 10.
PubMed 35582748Meador KJ, Dimova S, Bourikas D, Elmoufti S, Floricel F, Laloyaux C, Moseley B, Nondonfaz X, Klein P. Time-course of drug-related psychiatric and behavioral treatment-emergent adverse events during brivaracetam treatment in adults with focal-onset seizures. Epilepsy Behav. 2024 Jul;156:109844. doi: 10.1016/j.yebeh.2024.109844. Epub 2024 May 23.
PubMed 38788664Brandt 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 36435010
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study to Evaluate the Efficacy and Safety of Brivaracetam in Subjects (≥16 to 80 Years Old) With Partial Onset Seizures
- ClinicalTrials.gov ID
- NCT01261325
- Acronym / sponsor ID
- BRITE / N01358
- Conditions
- Epilepsy
- Keywords
- Epilepsy, Brivaracetam, Partial Onset Seizures, Adjunctive treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 768 participants (actual)
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 16 Dec 2010 (estimated)
- Results
- Posted 15 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the efficacy and safety of brivaracetam at doses of 100 and 200mg/day compared to placebo as adjunctive treatment in adult focal epilepsy subjects with partial onset seizures not fully controlled despite current treatment with 1 or 2 concomitant antiepileptic drugs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo, Drug: Antiepileptic drugs with market authorization available per countryMatching placebo tablets administered twice daily |
| Brivaracetam 100 mg/ day | Experimental | Drug: Brivaracetam, Drug: Antiepileptic drugs with market authorization available per countryBrivaracetam 50 mg/ day administered twice daily. |
| Brivaracetam 200 mg/ day | Experimental | Drug: Brivaracetam, Drug: Antiepileptic drugs with market authorization available per countryBrivaracetam 100 mg/ day administered twice daily |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Well-characterized focal epilepsy/epileptic syndrome according to the 1989 International League Against Epilepsy (ILAE) classification
- Presence of an EEG reading compatible with the clinical diagnosis of focal epilepsy within the last 5 years
- Presence of a brain MRI/computed tomography (CT) scan performed within the last 2 years
- Subjects having at least 8 Type I seizures [POS; focal seizures (according to the 1981 ILAE classification)] during the 8-week Baseline Period with at least 2 Type I seizures during each 4-week interval of the Baseline Period
- Subjects having at least 2 partial onset seizures whether or not secondarily generalized per month during the 3 months preceding V1
Key exclusion criteria (14 listed)
- Subject previously randomized within this study or any other prior study with BRV as a dosing arm
- Seizure type IA (1981 ILAE classification) nonmotor as only seizure type.
- Subject is currently treated with LEV or has taken LEV within 90 days prior to V1
- Subject has any medical or psychiatric condition, obvious cognitive impairment or mental retardation that, in the opinion of the Investigator, could jeopardize or would compromise the subject's ability to participate in this study
- Subjects whose seizures could not be reliably counted on a regular basis due to their fast and repetitive occurrence (clusters or flurries)
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 |
|---|---|---|
| PlaceboDaily oral dose of two equal intakes of placebo in a double-blinded way for the 12-week treatment period | Drug | Placebo |
| BrivaracetamDaily oral dose of two equal intakes of Brivaracetam 100 mg/ day in a double-blinded way for the 12-week treatment period | Drug | Brivaracetam 100 mg/ day |
| BrivaracetamDaily oral dose of two equal intakes of Brivaracetam 200 mg/ day in a double-blinded way for the 12-week treatment period. | Drug | Brivaracetam 200 mg/ day |
| Antiepileptic drugs with market authorization available per country | Drug | Brivaracetam 100 mg/ day, Brivaracetam 200 mg/ day, Placebo |
Primary outcome
Percent Reduction Over Placebo for Partial Onset Seizure (Type I) Frequency Over the Treatment Period Standardized to a 28-day Duration
Time frame: 12 week Treatment Period
Primary endpoint: United States of America (FDA)
50% Responder Rate for Partial Onset Seizure (Type I) Frequency Over the Treatment Period Standardized to a 28-day Duration
Time frame: Baseline to 12 week Treatment Period
Primary Endpoint: European Regulatory Authorities A responder is a participant who experienced a 50% or greater reduction in partial onset seizure (Type I) frequency over the Treatment Period standardized to a 28-day duration.
7 secondary outcomes
Percent Change in Partial Onset Seizure (Type I) Frequency From the Baseline to the Treatment Period
Time frame: Baseline to 12 week Treatment Period
Categorized Percent Reduction Form Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the Treatment Period
Time frame: Baseline to 12 week Treatment Period
Seizure Freedom Rate (All Seizure Types) During the 12-week Treatment Period
Time frame: 12 week Treatment Period
All Seizure Frequency (Type I + II + III) During the 12-week Treatment Period
Time frame: 12 week Treatment Period
Time to the First Type I Seizure During the Treatment Period
Time frame: 12 week Treatment Period
Time to the Fifth Type I Seizure During the Treatment Period
Time frame: 12 week Treatment Period
Time to the Tenth Type I Seizure During the Treatment Period
Time frame: 12 week Treatment Period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27265725Toledo M, Whitesides J, Schiemann J, Johnson ME, Eckhardt K, McDonough B, Borghs S, Kwan P. Safety, tolerability, and seizure control during long-term treatment with adjunctive brivaracetam for partial-onset seizures. Epilepsia. 2016 Jul;57(7):1139-51. doi: 10.1111/epi.13416. Epub 2016 Jun 6.
- Results publication: PubMed 27335114Ben-Menachem E, Mameniskiene R, Quarato PP, Klein P, Gamage J, Schiemann J, Johnson ME, Whitesides J, McDonough B, Eckhardt K. Efficacy and safety of brivaracetam for partial-onset seizures in 3 pooled clinical studies. Neurology. 2016 Jul 19;87(3):314-23. doi: 10.1212/WNL.0000000000002864. Epub 2016 Jun 22.
- Results publication: 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.
- Results publication: PubMed 27589414Brodie MJ, Whitesides J, Schiemann J, D'Souza J, Johnson ME. Tolerability, safety, and efficacy of adjunctive brivaracetam for focal seizures in older patients: A pooled analysis from three phase III studies. Epilepsy Res. 2016 Nov;127:114-118. doi: 10.1016/j.eplepsyres.2016.08.018. Epub 2016 Aug 18.
- Results publication: PubMed 27608437Moseley BD, Sperling MR, Asadi-Pooya AA, Diaz A, Elmouft S, Schiemann J, Whitesides J. Efficacy, safety, and tolerability of adjunctive brivaracetam for secondarily generalized tonic-clonic seizures: Pooled results from three Phase III studies. Epilepsy Res. 2016 Nov;127:179-185. doi: 10.1016/j.eplepsyres.2016.09.003. Epub 2016 Sep 3.
- Results publication: PubMed 28236727Brandt C, Borghs S, Elmoufti S, Mueller K, Townsend R, de la Loge C. Health-related quality of life in double-blind Phase III studies of brivaracetam as adjunctive therapy of focal seizures: A pooled, post-hoc analysis. Epilepsy Behav. 2017 Apr;69:80-85. doi: 10.1016/j.yebeh.2016.11.031. Epub 2017 Feb 23.
- Results publication: PubMed 27988967Klein P, Johnson ME, Schiemann J, Whitesides J. Time to onset of sustained >/=50% responder status in patients with focal (partial-onset) seizures in three phase III studies of adjunctive brivaracetam treatment. Epilepsia. 2017 Feb;58(2):e21-e25. doi: 10.1111/epi.13631. Epub 2016 Dec 18.
- Results publication: PubMed 28279891Asadi-Pooya AA, Sperling MR, Chung S, Klein P, Diaz A, Elmoufti S, Schiemann J, Whitesides J. Efficacy and tolerability of adjunctive brivaracetam in patients with prior antiepileptic drug exposure: A post-hoc study. Epilepsy Res. 2017 Mar;131:70-75. doi: 10.1016/j.eplepsyres.2017.02.007. Epub 2017 Feb 27.
- Results publication: PubMed 29414542Benbadis S, Klein P, Schiemann J, Diaz A, Elmoufti S, Whitesides J. Efficacy, safety, and tolerability of brivaracetam with concomitant lamotrigine or concomitant topiramate in pooled Phase III randomized, double-blind trials: A post-hoc analysis. Epilepsy Behav. 2018 Mar;80:129-134. doi: 10.1016/j.yebeh.2017.12.024. Epub 2018 Feb 3.
- Results publication: PubMed 29908435Brodie MJ, Fakhoury T, McDonough B, Colson AO, Stockis A, Elmoufti S, Whitesides J. Brivaracetam-induced elevation of carbamazepine epoxide levels: A post-hoc analysis from the clinical development program. Epilepsy Res. 2018 Sep;145:55-62. doi: 10.1016/j.eplepsyres.2018.06.002. Epub 2018 Jun 4.
- Results publication: PubMed 32432339Klein P, Laloyaux C, Elmoufti S, Gasalla T, Martin MS. Time course of 75%-100% efficacy response of adjunctive brivaracetam. Acta Neurol Scand. 2020 Aug;142(2):175-180. doi: 10.1111/ane.13287. Epub 2020 Jun 9.
- 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.
- 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 Clinical Trial Call Center study director
+1 877 822 9493 (UCB)
207 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 and Antiepileptic drugs with market authorization available per country in people with Epilepsy, run by UCB Pharma at 207 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 7 inclusion and 14 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 22 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 207 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. Some participants in this study may receive a placebo. 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 15 Aug 2016). 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 Reduction Over Placebo for Partial Onset Seizure (Type I) Frequency Over the Treatment Period Standardized to a 28-day Duration (time frame: 12 week Treatment Period). The study lists 2 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 NCT01261325, which also lists 19 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 22 Jul 2022.