Trial · NCT03083665
A Study to Evaluate the Efficacy and Safety of Brivaracetam in Study Participants (>=16 to 80 Years of Age) With Epilepsy
NCT03083665, Phase 3, Completed, UCB Biopharma SRL; results first posted 2023-11-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate the Efficacy and Safety of Brivaracetam in Study Participants (>=16 to 80 Years of Age) With Epilepsy. Trials, record NCT03083665. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03083665
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Efficacy and Safety of Brivaracetam in Study Participants (>=16 to 80 Years of Age) With Epilepsy
- NCT number
- NCT03083665
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 449 participants, actual
- Lead sponsor
- UCB Biopharma SRL
- Conditions
- Partial Seizures With or Without Secondary Generalization, Epilepsy
- Interventions
- Placebo, Brivaracetam
- First posted
- 2017-03-20
- Last updated
- 2025-10-14
- Results first posted
- 2023-11-09
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (up to 4 Years 10 Months) | An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. Treatment-Emergent AEs were defined as AEs which had onset on or after the first dose of IMP. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period. |
| Primary | Percentage of Participants With Treatment-Emergent AEs (TEAEs) Leading to Study Withdrawal | From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (up to 4 Years 10 Months) | An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. Treatment-Emergent AEs were defined as AEs which had onset on or after the first dose of IMP. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period. |
| Primary | Percentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs) | From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (up to 4 Years 10 Months) | Serious Adverse event (SAE) was defined as any events which: • results in death, • is life-threatening threatening (note that this did not include a reaction that might have caused death had it occurred in a more severe form.), •results in significant or persistent disability/incapacity, • results in a congenital anomaly/birth defect (including that occurring in a fetus), • results in Important medical event that, based upon appropriate medical judgment, may jeopardize the participant and might require medical or surgical intervention to prevent 1 of the other outcomes listed here, and • results in initial inpatient hospitalization or prolongation of hospitalization. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period. |
| Primary | Partial Seizure Frequency Per 28 Days During the 12-week Treatment Period | From Baseline to 12-week Treatment Period | According to International League Against Epilepsy (ILAE) classification (1981), seizures were classified as type IA (IA1, IA2, IA3, and IA4), IB, IC, II (IIA, IIB, IIC, IID, IIE, and IIF) or III. 28 day adjusted seizure frequency for partial seizures (seizure types IA+IB+IC) was calculated for treatment period by dividing the number of partial seizures by the number of days for which the DRC was completed for treatment period and multiplying the resulting value by 28. |
| Secondary | 50% Responder Rate Based on Percent Change in Partial Seizure Frequency Per 28 Days From Baseline to the 12-week Treatment Period | From Baseline to 12-week Treatment Period | Responders were those participants with at least 50% reduction from Baseline to the 12-week Treatment Period in partial seizure frequency per 28 days. 50% Responder rate was calculated for treatment period by dividing the number of 50% responders by the number of participants in the analysis set and multiplying the resulting value by 100. |
| Secondary | Percent Change in Partial Seizure Frequency Per 28 Days From Baseline to the 12-week Treatment Period | From Baseline to 12-week Treatment Period | Percent change from Baseline to the Treatment Period in partial seizure frequency was calculated by subtracting 28-day adjusted Treatment Period partial seizure frequency from 28-day adjusted Baseline Period partial seizure frequency, and multiplying the resulting quantity by 100 and dividing by the Baseline Period 28-day adjusted partial seizure frequency. A negative value in percent change from Baseline indicates a decrease in partial seizure frequency from Baseline to the Treatment Period. |
| Secondary | Percentage of Participants With Categorized Percent Change in Partial Seizure Frequency Per 28 Days From Baseline to the 12-week Treatment Period | From Baseline to 12-week Treatment Period | The percentage of participants within each of the following categories of percent change in partial seizure frequency from Baseline to the Treatment Period were summarized for each treatment group: 100%, 75% to less than 100%, 50% to less than 75%, 25% to less than 50%, -25% to less than 25%, and less than -25%. Percent change from Baseline to the Treatment Period in partial seizure frequency was calculated by subtracting 28-day adjusted Treatment Period partial seizure frequency from 28-day adjusted Baseline Period partial seizure frequency and multiplying the resulting quantity by 100 and dividing by the Baseline Period 28-day adjusted partial seizure frequency. |
| Secondary | All Seizure Frequency (Partial, Generalized, and Unclassified Epileptic Seizures) Per 28 Days During the 12-week Treatment Period | During the 12-week Treatment Period | There were three types of epileptic seizures: Partial epileptic seizures (Type I), Generalized epileptic seizures (Type II) and unclassified epileptic seizures (Type III). 28 day adjusted seizure frequency for all seizure types was calculated for treatment period by dividing the number of targeted seizures by the number of days for which the DRC was completed for treatment period and multiplying the resulting value by 28. |
| Secondary | Percentage of Participants Who Are Seizure Free (Partial, All Epileptic Seizures) During the 12-week Treatment Period | During the 12-week Treatment Period | Participants were defined as seizure free, if they did not have missing diary days and no reported seizures during the Treatment Period. |
| Secondary | Time to 1st Partial Seizure During the 12-week Treatment Period | During the 12-week Treatment Period | The evaluation of time to 1st partial seizure was based on the relative day of occurrence of the 1st partial seizure during the Treatment Period. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (up to 4 Years 10 Months) | The Safety Set (SS) included all randomized study participants who received at least 1 dose of IMP. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Treatment-Emergent AEs (TEAEs) Leading to Study Withdrawal | From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (up to 4 Years 10 Months) | The SS included all randomized study participants who received at least 1 dose of IMP. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs) | From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (up to 4 Years 10 Months) | The SS included all randomized study participants who received at least 1 dose of IMP. | percentage of participants | NUMBER |
| PRIMARY | Partial Seizure Frequency Per 28 Days During the 12-week Treatment Period | From Baseline to 12-week Treatment Period | The Full Analysis Set (FAS) consisted of all randomized study participants who received at least 1 dose of IMP and had at least 1 post Baseline seizure daily record card (DRC) data during the Treatment Period. | seizures per 28 days | MEDIAN |
| SECONDARY | 50% Responder Rate Based on Percent Change in Partial Seizure Frequency Per 28 Days From Baseline to the 12-week Treatment Period | From Baseline to 12-week Treatment Period | The FAS consisted of all randomized study participants who received at least 1 dose of IMP and had at least 1 post Baseline seizure DRC data during the Treatment Period. | percentage of responders | NUMBER |
| SECONDARY | Percent Change in Partial Seizure Frequency Per 28 Days From Baseline to the 12-week Treatment Period | From Baseline to 12-week Treatment Period | The FAS consisted of all randomized study participants who received at least 1 dose of IMP and had at least 1 post Baseline seizure DRC data during the Treatment Period. | percent change | MEDIAN |
| SECONDARY | Percentage of Participants With Categorized Percent Change in Partial Seizure Frequency Per 28 Days From Baseline to the 12-week Treatment Period | From Baseline to 12-week Treatment Period | The FAS consisted of all randomized study participants who received at least 1 dose of IMP and had at least 1 post Baseline seizure DRC data during the Treatment Period. | percentage of participants | NUMBER |
| SECONDARY | All Seizure Frequency (Partial, Generalized, and Unclassified Epileptic Seizures) Per 28 Days During the 12-week Treatment Period | During the 12-week Treatment Period | The FAS consisted of all randomized study participants who received at least 1 dose of IMP and had at least 1 post Baseline seizure DRC data during the Treatment Period. | seizures per 28 days | MEDIAN |
| SECONDARY | Percentage of Participants Who Are Seizure Free (Partial, All Epileptic Seizures) During the 12-week Treatment Period | During the 12-week Treatment Period | The FAS consisted of all randomized study participants who received at least 1 dose of IMP and had at least 1 post Baseline seizure DRC data during the Treatment Period. | percentage of participants | NUMBER |
| SECONDARY | Time to 1st Partial Seizure During the 12-week Treatment Period | During the 12-week Treatment Period | The FAS consisted of all randomized study participants who received at least 1 dose of IMP and had at least 1 post Baseline seizure DRC data during the Treatment Period. | days | MEDIAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group93
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | Placebo | 58.4 | percentage of participants | ||
| Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | BRV 50 mg/Day | 57.0 | percentage of participants | ||
| Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | BRV 200 mg/Day | 60.1 | percentage of participants | ||
| Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | Placebo to OLTP BRV | 26.6 | percentage of participants | ||
| Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | BRV 50 mg/Day to OLTP BRV | 19.1 | percentage of participants | ||
| Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | BRV 200 mg/Day to OLTP BRV | 23.0 | percentage of participants | ||
| Percentage of Participants With Treatment-Emergent AEs (TEAEs) Leading to Study Withdrawal | Placebo | 4.7 | percentage of participants | ||
| Percentage of Participants With Treatment-Emergent AEs (TEAEs) Leading to Study Withdrawal | BRV 50 mg/Day | 2.6 | percentage of participants | ||
| Percentage of Participants With Treatment-Emergent AEs (TEAEs) Leading to Study Withdrawal | BRV 200 mg/Day | 3.4 | percentage of participants | ||
| Percentage of Participants With Treatment-Emergent AEs (TEAEs) Leading to Study Withdrawal | Placebo to OLTP BRV | 0 | percentage of participants |
1 to 10 of 93Source ClinicalTrials.gov
See all 93 results by groupParticipant flow60
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-Blind Period | STARTED | Placebo | 149 | |
| Double-Blind Period | STARTED | BRV 50 mg/Day | 152 | |
| Double-Blind Period | STARTED | BRV 200 mg/Day | 148 | |
| Double-Blind Period | STARTED | Placebo to OLTP BRV | 0 | |
| Double-Blind Period | STARTED | BRV 50 mg/Day to OLTP BRV | 0 | |
| Double-Blind Period | STARTED | BRV 200 mg/Day to OLTP BRV | 0 | |
| Double-Blind Period | Started Treatment Period (12 Weeks) | Placebo | 149 | |
| Double-Blind Period | Started Treatment Period (12 Weeks) | BRV 50 mg/Day | 152 | |
| Double-Blind Period | Started Treatment Period (12 Weeks) | BRV 200 mg/Day | 148 | |
| Double-Blind Period | Started Treatment Period (12 Weeks) | Placebo to OLTP BRV | 0 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 participant flowAdverse events120
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Upper respiratory tract infection | Infections and infestations | Placebo | 7 | 149 | 8 |
| other | Upper respiratory tract infection | Infections and infestations | BRV 50 mg/Day | 10 | 151 | 14 |
| other | Upper respiratory tract infection | Infections and infestations | BRV 200 mg/Day | 8 | 148 | 9 |
| other | Upper respiratory tract infection | Infections and infestations | Placebo to OLTP BRV | 0 | 64 | 0 |
| other | Upper respiratory tract infection | Infections and infestations | BRV 50 mg/Day to OLTP BRV | 0 | 68 | 0 |
| other | Upper respiratory tract infection | Infections and infestations | BRV 200 mg/Day to OLTP BRV | 0 | 74 | 0 |
| other | Nasopharyngitis | Infections and infestations | Placebo | 10 | 149 | 11 |
| other | Nasopharyngitis | Infections and infestations | BRV 50 mg/Day | 7 | 151 | 10 |
| other | Nasopharyngitis | Infections and infestations | BRV 200 mg/Day | 10 | 148 | 10 |
| other | Nasopharyngitis | Infections and infestations | Placebo to OLTP BRV | 3 | 64 | 3 |
1 to 10 of 120Source ClinicalTrials.gov
See all 120 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 149 |
| Total, all-cause mortality | BRV 50 mg/Day | 1 | 151 |
| Total, all-cause mortality | BRV 200 mg/Day | 0 | 148 |
| Total, all-cause mortality | Placebo to OLTP BRV | 0 | 64 |
| Total, all-cause mortality | BRV 50 mg/Day to OLTP BRV | 0 | 68 |
| Total, all-cause mortality | BRV 200 mg/Day to OLTP BRV | 0 | 74 |
| Total, other adverse events | Placebo | 39 | 149 |
| Total, other adverse events | BRV 50 mg/Day | 42 | 151 |
| Total, other adverse events | BRV 200 mg/Day | 54 | 148 |
| Total, other adverse events | Placebo to OLTP BRV | 3 | 64 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40944847 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03083665
GET https://conductscience.org/api/trials/v1/NCT03083665/results?page=2