EpilepsyPhase 3NCT00150800
This Trial, Evaluating the Long-term Safety and Tolerability of Brivaracetam Will Provide Subjects Suffering From Epilepsy, Who May Have Benefited From Brivaracetam as Adjunctive Treatment, the Opportunity to Receive Open Label Brivaracetam Treatment
A Phase 3 study testing Brivaracetam in people with Epilepsy, run by UCB PHARMA Inc. (US) at 100 sites in 6 countries.
Trial summary
This trial, evaluating the long-term safety and tolerability of brivaracetam will provide subjects suffering from epilepsy, who may have benefited from brivaracetam as adjunctive treatment, the opportunity to receive open label brivaracetam treatment. 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
- 668 participants
- Where
- 100 sitesin 6 countries
- Study dates
- Jan 2006to Sep 2017
- 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
- Male/ female subjects from 16 years and on. Subjects under 18 years may only be included where legally permitted and ethically accepted
- Subjects with epilepsy who have participated in previous brivaracetam trials which allow access to the present study
- Subjects for whom the investigator believes a reasonable benefit from the long term administration of brivaracetam may be expected
- Female subjects without childbearing potential. Female subjects with child bearing potential are eligible if they use a medically accepted contraceptive method for the duration of the study
- Subject/ legally acceptable representative considered as reliable and capable of adhering to the protocol, visit schedule or medication intake according to the judgment of the Investigator
Who cannot join
- Severe medical, neurological and 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 brivaracetam study
- Pregnant or lactating women
- Participation in any clinical study of another investigational drug or device during the study
Trial locations and contacts
100 sites in 6 countries.
100 sites in 6 countries
United States46 sites
N01199 1396
Atlanta, Georgia
N01199 1385
Augusta, Georgia
N01199 1373
Baltimore, Maryland
N01199 1086
Bethesda, Maryland
N01199 1077
Burlington, Massachusetts
N01199 1367
Charlottesville, Virginia
N01199 1360
Chesterfield, Missouri
N01199 1356
Chicago, Illinois
N01199 1366
Cincinnati, Ohio
N01199 1054
Columbus, Ohio
N01199 1084
Dallas, Texas
N01199 1394
Dallas, Texas
N01199 1391
Detroit, Michigan
N01199 1395
Detroit, Michigan
N01199 1078
Fresno, California
N01199 1071
Grand Rapids, Michigan
N01199 1069
Great Falls, Montana
N01199 1081
Greenville, South Carolina
N01199 1064
Houston, Texas
N01199 1364
Lexington, Kentucky
N01199 1050
Little Rock, Arkansas
N01199 1380
Louisville, Kentucky
N01199 1369
Milwaukee, Wisconsin
N01199 1061
Nashville, Tennessee
N01199 1053
New York, New York
N01199 1392
Newport Beach, California
N01199 1052
Paducah, Kentucky
N01199 1055
Philadelphia, Pennsylvania
N01199 1059
Philadelphia, Pennsylvania
N01199 1051
Phoenix, Arizona
N01199 1362
Phoenix, Arizona
N01199 1359
Portland, Oregon
N01199 1393
Richmond, Virginia
N01199 1365
Rochester, New York
N01199 1083
Ruston, Louisiana
N01199 1389
Saint Paul, Minnesota
N01199 1082
Salt Lake City, Utah
N01199 1087
San Francisco, California
N01199 1368
San Francisco, California
N01199 1376
Seattle, Washington
N01199 1388
Springfield, Illinois
N01199 1352
St Louis, Missouri
N01199 1062
Toms River, New Jersey
N01199 1374
Tucson, Arizona
N01199 1079
Tupelo, Mississippi
N01199 1375
Wichita, Kansas
India18 sites
N01199 1045
Bangalore
N01199 1256
Bangalore
N01199 1257
Bangalore
N01199 1261
Bangalore
N01199 1046
Chennai
N01199 1042
Hyderabad
N01199 1253
Hyderabad
N01199 1262
Hyderabad
N01199 1258
Jaipur
N01199 1040
Lucknow
N01199 1250
Lucknow
N01199 1266
Mumbai, Maharashti
N01199 1043
Mumbai
N01199 1259
Mumbai
N01199 1265
Parel Mumbai
N01199 1251
Pune
N01199 1264
Pune Maharashtra
N01199 1263
Tirupati
Brazil13 sites
N01199 1028
Campinas
N01199 1325
Curitiba
N01199 1024
Florianópolis
N01199 1150
Florianópolis
N01199 1331
Porto Alegre
N01199 1332
Porto Alegre
N01199 1022
Riberao Preto
N01199 1023
Salvador
N01199 1029
São José do Rio Preto
N01199 1021
São Paulo
N01199 1027
São Paulo
N01199 1030
São Paulo
N01199 1326
São Paulo
Mexico10 sites
N01199 1010
Aguascalientes
N01199 1008
Chihuahua City
N01199 1009
Chihuahua City
N01199 1003
Guadalajara
N01199 1403
Mexico City
N01199 1005
Monterrey
N01199 1007
Monterrey
N01199 1002
San Luis Potosí City
N01199 1412
San Nicholas de Los Garza, Nuevo León
N01199 1001
Zapopan
Australia8 sites
N01199 1423
Adelaide, South Australia
N01199 1420
Chatswood, New South Wales
N01199 1427
Clayton, Victoria
N01199 1422
Fitzroy
N01199 1426
Parkville, Victoria
N01199 1430
Randwick, New South Wales
N01199 1421
West Heidelberg, Victoria
N01199 1428
Woodville, South Australia
Canada5 sites
N01199 1316
Edmonton, Alberta
N01199 1312
Greenfield Park, Quebec
N01199 1311
Montreal, Quebec
N01199 1314
Montreal, Quebec
N01199 1313
Québec, Quebec
About this study
Official title: An Open-label, Multi-center, Follow-up Trial to Evaluate Long Term Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment at a Flexible Dose up to a Maximum of 200 mg/Day in Subjects Aged 16 Years or Older Suffering From Epilepsy
This trial, evaluating the long-term safety and tolerability of brivaracetam will provide subjects suffering from epilepsy, who may have benefited from brivaracetam as adjunctive treatment, the opportunity to receive open label brivaracetam treatment.
Read the detailed description
Study access was limited to subjects having completed one of the previous brivaracetam (BRV) studies: N01193 [NCT00175825], N01252 [NCT00490035], N01253 [NCT00464269], N01254 [NCT00504881].
- Conditions
- Epilepsy
- Being tested
- Brivaracetam
- Keywords
- Brivaracetam, Epilepsy, Partial Onset Seizures, open label
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrivaracetamDrug
- Active Substance: Brivaracetam
- Pharmaceutical Form: Tablet
- Concentration: 10 mg and 25 mg
- Route of Administration: Oral
| Study group | Role | What they receive |
|---|---|---|
| Brivaracetam | Experimental | Brivaracetam used as adjunctive treatment, flexible dosing up to 200 mg /day in b.i.d (twice daily) administration. Dose increase or decrease can be made in increments of maximum 50 mg/day on a weekly basis. 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) During the Study Period
Treatment-Emergent Adverse Events (TEAEs) are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment.
Measured: Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
Percentage of Participants Who Withdrew Due to an Adverse Event (AE) During the Study Period
Adverse Events (AE) are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment.
Measured: Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
Percentage of Participants With a Serious Adverse Event (SAE) During the Study Period
A Serious Adverse Event (SAE) is any untoward medical incidence that occurs at any dose.
Measured: Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
Secondary outcomes (3)
Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days During the Evaluation Period
Baseline is the Baseline from subject's previous study of enrollment period. N01193 [NCT00175825], N01252 [NCT00490035], N01253 [NCT00464269], N01254 [NCT00504881].
A 28 day Type 1 seizure frequency is the total number of Type 1 seizures divided by the total number of days evaluated multiplied by 28.
Measured: From Baseline of the previous study to the Evaluation Period (up to 11 years)
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.
Measured: From Baseline of the previous study to the Evaluation Period (up to 11 years)
Percentage of Participants With Response for Partial Onset Seizure (POS) (Type I) Frequency Over the Evaluation Period
A responder is defined as a subject with a higher than or equal to (>=) 50 % change in seizure frequency from Baseline period of the previous study.
Measured: From Baseline of the previous study to the Evaluation Period (up to 11 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startJan 2006
- Primary completionSep 2017
- Study completionSep 2017
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 (3)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
- 668 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB PHARMA Inc. (US)
- 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
- NCT00150800
- Sponsor's protocol ID
- N01199
- Status last verified
- Aug 2021
- First submitted
- 6 Sep 2005
- Last updated
- 17 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Expanded access
- Available
Publications
O'Brien TJ, Borghs S, He QJ, Schulz AL, Yates S, Biton V. Long-term safety, efficacy, and quality of life outcomes with adjunctive brivaracetam treatment at individualized doses in patients with epilepsy: An up to 11-year, open-label, follow-up trial. Epilepsia. 2020 Apr;61(4):636-646. doi: 10.1111/epi.16484. Epub 2020 Mar 28.
PubMed 32221987Moseley 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 34218211Markham A. Brivaracetam: First Global Approval. Drugs. 2016 Mar;76(4):517-22. doi: 10.1007/s40265-016-0555-6.
PubMed 26899665
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, Multi-center, Follow-up Trial to Evaluate Long Term Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment at a Flexible Dose up to a Maximum of 200 mg/Day in Subjects Aged 16 Years or Older Suffering From Epilepsy
- ClinicalTrials.gov ID
- NCT00150800
- Acronym / sponsor ID
- N01199
- Conditions
- Epilepsy
- Keywords
- Brivaracetam, Epilepsy, Partial Onset Seizures, open label
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 668 participants (actual)
- Lead sponsor
- UCB PHARMA Inc. (US)Industry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 8 Sep 2005 (estimated)
- Results
- Posted 5 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial, evaluating the long-term safety and tolerability of brivaracetam will provide subjects suffering from epilepsy, who may have benefited from brivaracetam as adjunctive treatment, the opportunity to receive open label brivaracetam treatment.
Detailed description
Study access was limited to subjects having completed one of the previous brivaracetam (BRV) studies: N01193 [NCT00175825], N01252 [NCT00490035], N01253 [NCT00464269], N01254 [NCT00504881].
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 used as adjunctive treatment, flexible dosing up to 200 mg /day in b.i.d (twice daily) administration. Dose increase or decrease can be made in increments of maximum 50 mg/day on a weekly basis. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Male/ female subjects from 16 years and on. Subjects under 18 years may only be included where legally permitted and ethically accepted
- Subjects with epilepsy who have participated in previous brivaracetam trials which allow access to the present study
- Subjects for whom the investigator believes a reasonable benefit from the long term administration of brivaracetam may be expected
- Female subjects without childbearing potential. Female subjects with child bearing potential are eligible if they use a medically accepted contraceptive method for the duration of the study
- Subject/ legally acceptable representative considered as reliable and capable of adhering to the protocol, visit schedule or medication intake according to the judgment of the Investigator
Key exclusion criteria (4 listed)
- Severe medical, neurological and 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 brivaracetam study
- Pregnant or lactating women
- Participation in any clinical study of another investigational drug or device during the study
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 |
|---|---|---|
| Brivaracetam* Active Substance: Brivaracetam * Pharmaceutical Form: Tablet * Concentration: 10 mg and 25 mg * Route of Administration: Oral | Drug | Brivaracetam |
Primary outcome
Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) During the Study Period
Time frame: Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
Treatment-Emergent Adverse Events (TEAEs) are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment.
Percentage of Participants Who Withdrew Due to an Adverse Event (AE) During the Study Period
Time frame: Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
Adverse Events (AE) are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment.
Percentage of Participants With a Serious Adverse Event (SAE) During the Study Period
Time frame: Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
A Serious Adverse Event (SAE) is any untoward medical incidence that occurs at any dose.
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 to the Evaluation Period (up to 11 years)
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 to the Evaluation Period (up to 11 years)
Percentage of Participants With Response for Partial Onset Seizure (POS) (Type I) Frequency Over the Evaluation Period
Time frame: From Baseline of the previous study to the Evaluation Period (up to 11 years)
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 32221987O'Brien TJ, Borghs S, He QJ, Schulz AL, Yates S, Biton V. Long-term safety, efficacy, and quality of life outcomes with adjunctive brivaracetam treatment at individualized doses in patients with epilepsy: An up to 11-year, open-label, follow-up trial. Epilepsia. 2020 Apr;61(4):636-646. doi: 10.1111/epi.16484. Epub 2020 Mar 28.
- 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 26899665Markham A. Brivaracetam: First Global Approval. Drugs. 2016 Mar;76(4):517-22. doi: 10.1007/s40265-016-0555-6.
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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)
100 sites in 6 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 PHARMA Inc. (US) at 100 sites in 6 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 5 inclusion and 4 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 100 sites in United States, India, Brazil, Mexico, Australia and 1 more country. 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 5 Dec 2018). 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) During the Study Period (time frame: Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00150800, which also lists 3 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.