EpilepsyPhase 3NCT00699283
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 68 sites in 6 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 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
- 62 participants
- Where
- 68 sitesin 6 countries
- Study dates
- Aug 2008to Mar 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
68 sites in 6 countries.
68 sites in 6 countries
United States43 sites
Study site
Albuquerque, New Mexico
Study site
Atlanta, Georgia
Study site
Austin, Texas
Study site
Bedford, Texas
Study site
Bethlehem, Pennsylvania
Study site
Bluefield, Virginia
Study site
Burlington, Vermont
Study site
Charlotte, North Carolina
Study site
Chicago, Illinois
Study site
Columbia, Missouri
Study site
Danbury, Connecticut
Study site
Danville, Indiana
Study site
Denver, Colorado
Study site
Elkhart, Indiana
Study site
Flushing, New York
Study site
Fort Collins, Colorado
Study site
Gainesville, Florida
Study site
Garden Grove, California
Study site
Grand Rapids, Michigan
Study site
Honolulu, Hawaii
Study site
Jenkintown, Pennsylvania
Study site
Layton, Utah
Study site
Lebanon, New Hampshire
Study site
Little Rock, Arkansas
Study site
Loma Linda, California
Study site
Marshfield, Wisconsin
Study site
Miami, Florida
Study site
Morgantown, West Virginia
Study site
New Haven, Connecticut
Study site
Newport Beach, California
Study site
Oberlin, Ohio
Study site
Ogden, Utah
Study site
Providence, Rhode Island
Study site
Riverside, California
Study site
Sacramento, California
Study site
San Antonio, Texas
Study site
Schenectady, New York
Study site
Seattle, Washington
Study site
Stanford, California
Study site
Tulsa, Oklahoma
Study site
Waldorf, Maryland
Study site
Waterbury, Connecticut
Study site
Westerville, Ohio
Italy7 sites
Study site
Bergamo
Study site
Florence
Study site
Germaneto
Study site
Messina
Study site
Perugia
Study site
Pisa
Study site
Torino
Germany6 sites
Study site
Berlin
Study site
Bernau
Study site
Bielefeld
Study site
München
Study site
Münster
Study site
Ulm
France4 sites
Study site
Béthune
Study site
Lille
Study site
Saint-Brieuc
Study site
Toulouse
Hungary4 sites
Study site
Budapest
Study site
Debrecen
Study site
Kecskemét
Study site
Szeged
Spain4 sites
Study site
Barcelona
Study site
Madrid
Study site
Murcia
Study site
Zaragoza
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 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 (BRV) 1 | Experimental | 50 mg daily Receives: Drug: Brivaracetam |
| Brivaracetam (BRV) 2 | Experimental | 100 mg daily 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 Visit 4 (week 1) to the end of the Evaluation Period (week 17) (approximately 16 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 completionMar 2010
- Study completionMar 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
- 62 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
- NCT00699283
- Sponsor's protocol ID
- N01306
- Other IDs
- RPCE07F1216, 2008-000145-58, 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
- No
- 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
- NCT00699283
- Acronym / sponsor ID
- N01306
- 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
- 62 participants (actual)
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 17 Jun 2008 (estimated)
- Results
- Posted 18 Jan 2017
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 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 (BRV) 1 | Experimental | Drug: Brivaracetam50 mg daily |
| Brivaracetam (BRV) 2 | Experimental | Drug: Brivaracetam100 mg daily |
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 (BRV) 1 |
| 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 (BRV) 2 |
Primary outcome
The Cumulative Exit Rate at 112 Days After the Beginning of the Baseline Antiepileptic Drug (AED) Tapering Phase
Time frame: From Visit 4 (week 1) to the end of the Evaluation Period (week 17) (approximately 16 weeks)
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.
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.
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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)
68 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 at 68 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 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 68 sites in United States, Italy, Germany, France, Hungary 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 18 Jan 2017). 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 Visit 4 (week 1) to the end of the Evaluation Period (week 17) (approximately 16 weeks)). 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 NCT00699283, 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.