EpilepsyPhase 3NCT00698581
A Double-blind, Randomized Conversion to Monotherapy Study to Evaluate the Efficacy and Safety of Brivaracetam in Subjects (≥ 16 to 75 Years Old) With Partial Onset Seizures
A Phase 3 study testing Brivaracetam in people with Epilepsy, run by UCB Pharma at 53 sites in 7 countries.
Trial summary
Antiepileptic drugs (AEDs) are the main treatment for epilepsy; however, only a limited number of AEDs are approved for use as monotherapy. The objective of this study is to evaluate the efficacy of Brivaracetam (BRV) in the conversion of partial onset seizure patients from combination treatment to monotherapy Read more about this study
- Who is it for?
- Ages 16 to 75 years
- 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
- 88 participants
- Where
- 53 sitesin 7 countries
- Study dates
- Aug 2008to Feb 2010
- 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 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects from 16 to 75 years, both inclusive
- Well-characterized focal epilepsy or epileptic syndrome
- Subjects having at least 2 but not exceeding 40 partial onset seizures, whether or not secondarily generalized per 4 weeks during the 8-week Baseline Period
- Subjects on a stable dose of at least 1 but no more than 2 concomitant Antiepileptic Drugs (AEDs) with the second AED ≤ 50 % of the minimum recommended maintenance dose
Who cannot join
- Seizure type IA non-motor as only seizure type
- History or presence of seizures occurring too frequently or indistinctly separated to be reliably counted during the 6 months preceding Visit 1 or during Baseline
- Other serious uncontrolled disease
Trial locations and contacts
53 sites in 7 countries.
53 sites in 7 countries
United States26 sites
Study site
Austin, Texas
Study site
Burlington, Massachusetts
Study site
Charleston, West Virginia
Study site
Conyers, Georgia
Study site
Dallas, Texas
Study site
Danville, Virginia
Study site
Denver, Colorado
Study site
Fresno, California
Study site
Germantown, Tennessee
Study site
Hickory, North Carolina
Study site
Houston, Texas
Study site
Kettering, Ohio
Study site
Las Vegas, Nevada
Study site
Lexington, Kentucky
Study site
Macon, Georgia
Study site
Miami, Florida
Study site
Mineola, New York
Study site
New York, New York
Study site
Oklahoma City, Oklahoma
Study site
Orlando, Florida
Study site
Pasadena, California
Study site
Peoria, Illinois
Study site
Phoenix, Arizona
Study site
Summit, New Jersey
Study site
The Bronx, New York
Study site
Waukesha, Wisconsin
Australia6 sites
Study site
Adelaide, South Australia
Study site
Chatswood, New South Wales
Study site
Clayton, Victoria
Study site
Fitzroy, Victoria
Study site
Parkville, Victoria
Study site
West Heidelberg, Victoria
Czechia6 sites
Study site
Brno
Study site
Litomyšl
Study site
Ostava
Study site
Ostrava-Trebovice
Study site
Prague
Study site
Praha-4
Canada5 sites
Study site
Calgary, Alberta
Study site
Edmonton, Alberta
Study site
Sakaskatoon, Saskatchewan
Study site
Toronto, Ontario
Study site
Windsor, Ontario
Germany4 sites
Study site
Aschaffenburg
Study site
Halle
Study site
Mainz
Study site
Regensburg
Sweden4 sites
Study site
Gothenburg
Study site
Lund
Study site
Stockholm
Study site
Uppsala
About this study
Official title: An International, Double-blind, Randomized, Multi-center, Parallel Group, Historical-control Conversion to Monotherapy Study to Evaluate the Efficacy and Safety of Brivaracetam in Subjects (≥ 16 to 75 Years Old) With Partial Onset Seizures With or Without Secondary Generalization
Antiepileptic drugs (AEDs) are the main treatment for epilepsy; however, only a limited number of AEDs are approved for use as monotherapy. The objective of this study is to evaluate the efficacy of Brivaracetam (BRV) in the conversion of partial onset seizure patients from combination treatment to monotherapy
- Conditions
- Epilepsy
- Being tested
- Brivaracetam
- Keywords
- Epilepsy; Monotherapy, Partial Onset Seizures, Adults and Adolescents
- 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 ucb 34714
25 mg tablet - 50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg > 20 mg) for subjects not participating in the follow-up study)
BrivaracetamDrug
Also called ucb 34714
25 mg tablet - 100 mg daily for 17 weeks (or 21 weeks if down-titrated (100 mg > 50 mg > 20 mg) for subjects not participating in the follow-up study)
| Study group | Role | What they receive |
|---|---|---|
| Brivaracetam 50 mg | Experimental | 50 mg/day Receives: Drug: Brivaracetam |
| Brivaracetam 100 mg | Experimental | 100 mg/day Receives: Drug: Brivaracetam |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Cumulative Exit Rate at 112 Days After the Beginning of the Baseline Antiepileptic Drug (AED) Tapering Phase
The cumulative exit rate was estimated using Kaplan-Meier methods and was based on the duration between start of the Evaluation Period (EP) and the earliest date the first exit criterion was met for each subject. Subjects completing the EP without meeting an exit criterion were censored on Day 112. The primary comparison was BRV 50 mg/day vs a historical control. The upper limit of the 2-sided 95 % Confidence Interval for the estimate was compared to the historical lower bound estimate of 0.722.
Measured: From Week 1 up to Week 17
Secondary outcomes (3)
The Number of Patients Reporting at Least One Treatment-Emergent Adverse Event (TEAE) During the Course of the Study
Measured: Baseline through Re-conversion (approximately 31 weeks)
The Number of Patient Withdrawal Due to Adverse Events (AEs) During the Course of the Study
Measured: Baseline through Re-conversion (approximately 31 weeks)
The Number of Patients Reporting at Least One Serious Adverse Event (SAE) During the Course of the Study
Measured: Baseline through Re-conversion (approximately 31 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2008 (estimated)
- Study startAug 2008
- Primary completionJan 2010
- Study completionFeb 2010
Why it stopped: An interim analysis revealed the study was unlikely to attain a positive outcome for the efficacy analysis. No safety concerns were detected.
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 (1)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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 88 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
- NCT00698581
- Sponsor's protocol ID
- N01276
- Other IDs
- 2008-000144-14, 2008
- Status last verified
- Mar 2018
- First submitted
- 12 Jun 2008
- Last updated
- 11 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Expanded access
- Available
Publications
Arnold S, Badalamenti V, Diaz A, Gasalla T, McShea C, Whitesides J, Fakhoury T. Conversion to brivaracetam monotherapy for the treatment of patients with focal seizures: Two double-blind, randomized, multicenter, historical control, Phase III studies. Epilepsy Res. 2018 Mar;141:73-82. doi: 10.1016/j.eplepsyres.2018.02.005. Epub 2018 Feb 12.
PubMed 29486396
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An International, Double-blind, Randomized, Multi-center, Parallel Group, Historical-control Conversion to Monotherapy Study to Evaluate the Efficacy and Safety of Brivaracetam in Subjects (≥ 16 to 75 Years Old) With Partial Onset Seizures With or Without Secondary Generalization
- ClinicalTrials.gov ID
- NCT00698581
- Acronym / sponsor ID
- N01276
- Conditions
- Epilepsy
- Keywords
- Epilepsy; Monotherapy, Partial Onset Seizures, Adults and Adolescents
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: An interim analysis revealed the study was unlikely to attain a positive outcome for the efficacy analysis. No safety concerns were detected.
- Enrolment
- 88 participants (actual)
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 17 Jun 2008 (estimated)
- Results
- Posted 13 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Antiepileptic drugs (AEDs) are the main treatment for epilepsy; however, only a limited number of AEDs are approved for use as monotherapy. The objective of this study is to evaluate the efficacy of Brivaracetam (BRV) in the conversion of partial onset seizure patients from combination treatment to monotherapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brivaracetam 50 mg | Experimental | Drug: Brivaracetam50 mg/day |
| Brivaracetam 100 mg | Experimental | Drug: Brivaracetam100 mg/day |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects from 16 to 75 years, both inclusive
- Well-characterized focal epilepsy or epileptic syndrome
- Subjects having at least 2 but not exceeding 40 partial onset seizures, whether or not secondarily generalized per 4 weeks during the 8-week Baseline Period
- Subjects on a stable dose of at least 1 but no more than 2 concomitant Antiepileptic Drugs (AEDs) with the second AED ≤ 50 % of the minimum recommended maintenance dose
Key exclusion criteria (3 listed)
- Seizure type IA non-motor as only seizure type
- History or presence of seizures occurring too frequently or indistinctly separated to be reliably counted during the 6 months preceding Visit 1 or during Baseline
- Other serious uncontrolled disease
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: ucb 3471425 mg tablet - 50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg > 20 mg) for subjects not participating in the follow-up study) | Drug | Brivaracetam 50 mg |
| BrivaracetamAlso: ucb 3471425 mg tablet - 100 mg daily for 17 weeks (or 21 weeks if down-titrated (100 mg > 50 mg > 20 mg) for subjects not participating in the follow-up study) | Drug | Brivaracetam 100 mg |
Primary outcome
The Cumulative Exit Rate at 112 Days After the Beginning of the Baseline Antiepileptic Drug (AED) Tapering Phase
Time frame: From Week 1 up to Week 17
The cumulative exit rate was estimated using Kaplan-Meier methods and was based on the duration between start of the Evaluation Period (EP) and the earliest date the first exit criterion was met for each subject. Subjects completing the EP without meeting an exit criterion were censored on Day 112. The primary comparison was BRV 50 mg/day vs a historical control. The upper limit of the 2-sided 95 % Confidence Interval for the estimate was compared to the historical lower bound estimate of 0.722.
3 secondary outcomes
The Number of Patients Reporting at Least One Treatment-Emergent Adverse Event (TEAE) During the Course of the Study
Time frame: Baseline through Re-conversion (approximately 31 weeks)
The Number of Patient Withdrawal Due to Adverse Events (AEs) During the Course of the Study
Time frame: Baseline through Re-conversion (approximately 31 weeks)
The Number of Patients Reporting at Least One Serious Adverse Event (SAE) During the Course of the Study
Time frame: Baseline through Re-conversion (approximately 31 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 29486396Arnold S, Badalamenti V, Diaz A, Gasalla T, McShea C, Whitesides J, Fakhoury T. Conversion to brivaracetam monotherapy for the treatment of patients with focal seizures: Two double-blind, randomized, multicenter, historical control, Phase III studies. Epilepsy Res. 2018 Mar;141:73-82. doi: 10.1016/j.eplepsyres.2018.02.005. Epub 2018 Feb 12.
Related trials for Epilepsy
Active, not recruitingPhase 3
A Phase 3, Placebo-Controlled Study to Investigate LP352 in Children and Adults With Dravet Syndrome (DS)
Dravet Syndrome
RecruitingObservational study
Epilepsy Seizure Detection With Innovative Tripolar EEG (tEEG)
Epilepsy
Enrolling by invitationPhase 2
SPN-817 Open-Label Extension Study in Adults With Focal Onset Seizures
Focal Onset Seizures
Not yet recruiting
Biomarker Targeted Stimulation for Epileptiform Events
Epilepsy
Enrolling by invitationObservational study
Study of Direct Brain Recording and Stimulation for Memory Enhancement
Epilepsy
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)
53 sites in 7 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 at 53 sites in 7 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 3 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: stopped early, as of the sponsor's last update on 11 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 sites in United States, Australia, Czechia, Canada, Germany and 2 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 13 Apr 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?
The Cumulative Exit Rate at 112 Days After the Beginning of the Baseline Antiepileptic Drug (AED) Tapering Phase (time frame: From Week 1 up to Week 17). 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 NCT00698581, which also lists 1 linked publication.
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 11 Jul 2018.