Trial · NCT01364597
Open-label Long-term Study of Adjunctive Brivaracetam in Pediatric Subjects With Epilepsy
NCT01364597, Phase 3, Completed, UCB Pharma SA; results first posted 2022-08-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Open-label Long-term Study of Adjunctive Brivaracetam in Pediatric Subjects With Epilepsy. Trials, record NCT01364597. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01364597
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open-label Long-term Study of Adjunctive Brivaracetam in Pediatric Subjects With Epilepsy
- NCT number
- NCT01364597
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 257 participants, actual
- Lead sponsor
- UCB Pharma SA
- Conditions
- Epilepsy
- Interventions
- Brivaracetam (BRV)
- First posted
- 2011-06-02
- Last updated
- 2025-10-20
- Other registries' IDs
- eudract:2011-000374-60
- Results first posted
- 2022-08-29
Source ClinicalTrials.gov
Registered outcomes11
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) During the Study | From Baseline to end of study (up to 10 years) | TEAEs are defined as AEs that had onset on or after the day of first BRV dose. |
| Primary | Percentage of Participants With Treatment-emergent Serious Adverse Events (SAEs) During the Study | From Baseline to end of study (up to 10 years) | TEAEs are defined as AEs that had onset on or after the day of first BRV dose. A SAE was defined as an event that met 1 or more of the below criteria: a) Death, b) Life-threatening, (Life-threatening did not include a reaction that might have caused death had it occurred in a more severe form.) c) Significant or persistent disability/incapacity, d) Congenital anomaly/birth defect (including that occurring in a fetus), e) Important medical event that, based upon appropriate medical judgment, may have jeopardized participant and may have required medical or surgical intervention to prevent 1 of the other outcomes listed in the definition of serious, (Important medical events may have included allergic bronchospasm requiring intensive treatment in an emergency room \[ER\] or at home) f) Initial inpatient hospitalization or prolongation of hospitalization. (A participant admitted to a hospital, even if released on the same day, met the criteria for the initial inpatient hospitalization). |
| Secondary | Absolute Change in 28-days Adjusted Partial-onset-seizure (POS) Frequency for Participants Aged ≥2 Years From Baseline to the End of the Evaluation Period in Participants With POS Only (Based on Daily Record Card [DRC]) | From Baseline (LTFU participants: Baseline of previous studies N01263 [NCT00422422]; and DE participants: Baseline of current study) to the end of the evaluation period (up to 10 years) | Absolute change in seizure frequency per 28 days based on the daily record card (DRC) data, is calculated as baseline seizure frequency per 28 days minus post-Baseline seizure frequency per 28 days. The 28 day adjusted seizure frequency was calculated by dividing the number of partial seizures by the number of days for which the diary was completed, and multiplying the resulting value by 28. This OM was analyzed in participants ≥2 years (per DRC data) only. Here in the study FAS indicates Full Analysis Set, EEG indicates electroencephalogram, OM indicates Outcome measure |
| Secondary | Percent Change in 28-days Adjusted Partial-onset-seizure (POS) Frequency for Participants Aged ≥2 Years From Baseline to the End of the Evaluation Period in Participants With POS Only (Based on DRC Data) | From Baseline (LTFU participants: Baseline of previous studies N01263 [NCT00422422]; and DE participants: Baseline of current study) to the end of the evaluation period (up to 10 years) | Percent change is calculated as absolute change in seizure frequency per 28 days divided by baseline seizure frequency per 28 Days multiplied to 100. The 28 day adjusted seizure frequency was calculated by dividing the number of partial seizures by the number of days for which the diary was completed, and multiplying the resulting value by 28. This OM was analyzed in participants ≥2 years (per DRC data) only. |
| Secondary | 50% Responder Rate for Participants ≥2 Years of Age for Total Seizures (All Types) (Based on DRC Data) | From Baseline (LTFU participants: Baseline of previous studies N01263 [NCT00422422]; and DE participants: Baseline of current study) to the end of the evaluation period (up to 10 years) | A responder is defined as a participant with a ≥50% reduction in seizure frequency from the baseline period of the previous study for LTFU participants or during this study for DE participants. This OM was analyzed in participants ≥2 years (per DRC data) only. |
| Secondary | Absolute Change in Average Daily Frequency (ADF) of Partial-onset-seizures (POS) in Participants <2 Years of Age With POS Only (Based on EEG Data) | From Baseline (LTFU participants: Baseline of previous studies N01263 [NCT00422422] or N01349 [NCT03325439]) to the end of the evaluation period (up to 10 years) | Absolute change in ADF is calculated as the baseline ADF minus post-baseline ADF. ADF is calculated as (number of seizures from central reader divided by stop date and time of EEG minus start date and time of EEG) multiplied to 60, multiplied to 24. This OM was analyzed in participants \<2 years (per EEG data) only. |
| Secondary | Percent Change in Average Daily Frequency (ADF) of Partial-onset-seizures (POS) in Participants <2 Years of Age With POS Only (Based on EEG Data) | From Baseline (LTFU participants: Baseline of previous studies N01263 [NCT00422422] or N01349 [NCT03325439]) to the end of the evaluation period (up to 10 years) | Percent change in average daily frequency (ADF) is calculated as absolute change in ADF divided by baseline ADF multiplied to 100. ADF is calculated as (number of seizures from central reader divided by stop date and time of EEG minus start date and time of EEG) multiplied to 60, multiplied to 24. This OM was analyzed in participants \<2 years (per EEG data) only. |
| Secondary | 50% Responder Rate for Participants <2 Years of Age for Total Seizures (All Types) (Based on EEG Data) | From Baseline (LTFU participants: Baseline of previous studies N01263 [NCT00422422] or N01349 [NCT03325439]) to the end of the evaluation period (up to 10 years) | A responder is defined as a participant with a ≥50% reduction in seizure frequency from the baseline period of the previous study for LTFU participants. This OM was analyzed in participants \<2 years (per EEG data) only. |
| Secondary | Absolute Change in Average Daily Frequency of POS in Participants <2 Years of Age With Typical Absence Seizures (Based on EEG Data) | From Baseline (LTFU participants: Baseline of previous studies N01263 [NCT00422422] or N01349 [NCT03325439]) to the end of the evaluation period (up to 10 years) | Absolute change in ADF is calculated as the baseline ADF minus post-baseline ADF. ADF is calculated as (number of seizures from central reader divided by stop date and time of EEG minus start date and time of EEG) multiplied to 60, multiplied to 24. |
| Secondary | Percent Change in Average Daily Frequency of POS in Participants <2 Years of Age With Typical Absence Seizures (Based on EEG Data) | From Baseline (LTFU participants: Baseline of previous studies N01263 [NCT00422422] or N01349 [NCT03325439]) to the end of the evaluation period (up to 10 years) | Percent change in average daily frequency (ADF) is calculated as absolute change in ADF divided by baseline ADF multiplied to 100. ADF is calculated as (number of seizures from central reader divided by stop date and time of EEG minus start date and time of EEG) multiplied to 60, multiplied to 24. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
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) During the Study | From Baseline to end of study (up to 10 years) | The Safety Set (SS) consisted of all enrolled participants who took at least 1 dose of study medication. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Treatment-emergent Serious Adverse Events (SAEs) During the Study | From Baseline to end of study (up to 10 years) | The Safety Set (SS) consisted of all enrolled participants who took at least 1 dose of study medication. | percentage of participants | NUMBER |
| SECONDARY | Absolute Change in 28-days Adjusted Partial-onset-seizure (POS) Frequency for Participants Aged ≥2 Years From Baseline to the End of the Evaluation Period in Participants With POS Only (Based on Daily Record Card [DRC]) | From Baseline (LTFU participants: Baseline of previous studies N01263 [NCT00422422]; and DE participants: Baseline of current study) to the end of the evaluation period (up to 10 years) | FAS: enrolled participants who had at least 1 dose of study drug in the study and had at least 1 completed post-baseline DRC or EEG. Overall number of participants analyzed consist of all participants (≥2 years only \[per DRC data\]) evaluable for this OM and it differs in absolute and percent change OMs as later cannot be analyzed with 0 baseline ADF. Per plan, participants were grouped per cohort linked to source (DRC for ≥2 years/EEG for \<2 years) from which their seizure data is recorded. | seizure frequency per 28-days | MEAN |
| SECONDARY | Percent Change in 28-days Adjusted Partial-onset-seizure (POS) Frequency for Participants Aged ≥2 Years From Baseline to the End of the Evaluation Period in Participants With POS Only (Based on DRC Data) | From Baseline (LTFU participants: Baseline of previous studies N01263 [NCT00422422]; and DE participants: Baseline of current study) to the end of the evaluation period (up to 10 years) | FAS: enrolled participants who had at least 1 dose of study drug in the study and had at least 1 completed post-baseline DRC or EEG. Overall number of participants analyzed consist of all participants (≥2 years only \[per DRC data\]) evaluable for this OM and it differs in absolute and percent change OMs as later cannot be analyzed with 0 baseline ADF. Per plan, participants were grouped per cohort linked to source (DRC for ≥2 years/EEG for \<2 years) from which their seizure data is recorded. | percent change | MEAN |
| SECONDARY | 50% Responder Rate for Participants ≥2 Years of Age for Total Seizures (All Types) (Based on DRC Data) | From Baseline (LTFU participants: Baseline of previous studies N01263 [NCT00422422]; and DE participants: Baseline of current study) to the end of the evaluation period (up to 10 years) | FAS: all enrolled participants who took at least 1 dose of study drug in this Long-term study and had at least 1 completed post-baseline DRC or EEG. Overall number of participants analyzed included all participants evaluable for this OM. Per planned analysis, participants were grouped as per cohort linked to source (DRC for ≥2 years /EEG for \<2 years) from which their seizure data is recorded. This OM was analyzed in participants ≥2 years of age (per DRC data) only. | percentage of participants | NUMBER |
| SECONDARY | Absolute Change in Average Daily Frequency (ADF) of Partial-onset-seizures (POS) in Participants <2 Years of Age With POS Only (Based on EEG Data) | From Baseline (LTFU participants: Baseline of previous studies N01263 [NCT00422422] or N01349 [NCT03325439]) to the end of the evaluation period (up to 10 years) | FAS: enrolled participants who had at least 1 dose of study drug in the study and had at least 1 completed post-baseline DRC or EEG. Overall number of participants analyzed consist of all participants (\<2 years only \[per EEG data\]) evaluable for this OM and it differs in absolute and percent change OMs as later cannot be analyzed with 0 baseline ADF. Per plan, participants were grouped per cohort linked to source (DRC for ≥2 years/EEG for \<2 years) from which their seizure data is recorded. | seizures per day | MEAN |
| SECONDARY | Percent Change in Average Daily Frequency (ADF) of Partial-onset-seizures (POS) in Participants <2 Years of Age With POS Only (Based on EEG Data) | From Baseline (LTFU participants: Baseline of previous studies N01263 [NCT00422422] or N01349 [NCT03325439]) to the end of the evaluation period (up to 10 years) | FAS: enrolled participants who had at least 1 dose of study drug in the study and had at least 1 completed post-baseline DRC or EEG. Overall number of participants analyzed consist of all participants (\<2 years only \[per EEG data\]) evaluable for this OM and it differs in absolute and percent change OMs as later cannot be analyzed with 0 baseline ADF. Per plan, participants were grouped per cohort linked to source (DRC for ≥2 years/EEG for \<2 years) from which their seizure data is recorded. | percent change | MEAN |
| SECONDARY | 50% Responder Rate for Participants <2 Years of Age for Total Seizures (All Types) (Based on EEG Data) | From Baseline (LTFU participants: Baseline of previous studies N01263 [NCT00422422] or N01349 [NCT03325439]) to the end of the evaluation period (up to 10 years) | FAS: enrolled participants who had at least 1 dose of study drug in the study and had at least 1 completed post-baseline DRC or EEG. Overall number of participants analyzed consist of all participants (\<2 years only \[per EEG data\]) evaluable for this OM. Per plan, participants were grouped per cohort linked to source (DRC for ≥2 years/EEG for \<2 years) from which their seizure data is recorded. | percentage of participants | NUMBER |
| SECONDARY | Absolute Change in Average Daily Frequency of POS in Participants <2 Years of Age With Typical Absence Seizures (Based on EEG Data) | From Baseline (LTFU participants: Baseline of previous studies N01263 [NCT00422422] or N01349 [NCT03325439]) to the end of the evaluation period (up to 10 years) | Typical absence seizures data was not collected and analyzed. | ||
| SECONDARY | Percent Change in Average Daily Frequency of POS in Participants <2 Years of Age With Typical Absence Seizures (Based on EEG Data) | From Baseline (LTFU participants: Baseline of previous studies N01263 [NCT00422422] or N01349 [NCT03325439]) to the end of the evaluation period (up to 10 years) | Typical absence seizures data was not collected and analyzed. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group14
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) During the Study | Age Cohort: ≥1 Month to <2 Years | 94.4 | percentage of participants | ||
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study | Age Cohort: ≥2 to <4 Years | 93.3 | percentage of participants | ||
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study | Age Cohort: ≥4 to <12 Years | 93.6 | percentage of participants | ||
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study | Age Cohort: ≥12 to <17 Years | 92.3 | percentage of participants | ||
| Percentage of Participants With Treatment-emergent Serious Adverse Events (SAEs) During the Study | Age Cohort: ≥1 Month to <2 Years | 38.9 | percentage of participants | ||
| Percentage of Participants With Treatment-emergent Serious Adverse Events (SAEs) During the Study | Age Cohort: ≥2 to <4 Years | 53.3 | percentage of participants | ||
| Percentage of Participants With Treatment-emergent Serious Adverse Events (SAEs) During the Study | Age Cohort: ≥4 to <12 Years | 29.8 | percentage of participants | ||
| Percentage of Participants With Treatment-emergent Serious Adverse Events (SAEs) During the Study | Age Cohort: ≥12 to <17 Years | 29.2 | percentage of participants | ||
Absolute Change in 28-days Adjusted Partial-onset-seizure (POS) Frequency for Participants Aged ≥2 Years From Baseline to the End of the Evaluation Period in Participants With POS Only (Based on Daily Record Card [DRC]) | Brivaracetam (BRV): Participants ≥ 2 Years to <17 Years | -37.48 | Standard Deviation 628.34 | seizure frequency per 28-days | |
Percent Change in 28-days Adjusted Partial-onset-seizure (POS) Frequency for Participants Aged ≥2 Years From Baseline to the End of the Evaluation Period in Participants With POS Only (Based on DRC Data) | Brivaracetam (BRV): Participants ≥ 2 Years to <17 Years | 26.57 | Standard Deviation 123.06 | percent change |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Age Cohort: ≥1 Month to <2 Years | 36 | |
| Overall Study | STARTED | Age Cohort: ≥2 to <4 Years | 15 | |
| Overall Study | STARTED | Age Cohort: ≥4 to <12 Years | 141 | |
| Overall Study | STARTED | Age Cohort: ≥12 to <17 Years | 65 | |
| Overall Study | Directly Enrolled (DE) Participants | Age Cohort: ≥1 Month to <2 Years | 0 | |
| Overall Study | Directly Enrolled (DE) Participants | Age Cohort: ≥2 to <4 Years | 0 | |
| Overall Study | Directly Enrolled (DE) Participants | Age Cohort: ≥4 to <12 Years | 85 | |
| Overall Study | Directly Enrolled (DE) Participants | Age Cohort: ≥12 to <17 Years | 35 | |
| Overall Study | Long-term Follow-up (LTFU) Participants | Age Cohort: ≥1 Month to <2 Years | 36 | |
| Overall Study | Long-term Follow-up (LTFU) Participants | Age Cohort: ≥2 to <4 Years | 15 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events852
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 | Anaemia | Blood and lymphatic system disorders | Age Cohort: ≥1 Month to <2 Years | 3 | 36 | 5 |
| other | Anaemia | Blood and lymphatic system disorders | Age Cohort: ≥2 to <4 Years | 0 | 15 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Age Cohort: ≥4 to <12 Years | 0 | 141 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Age Cohort: ≥12 to <17 Years | 1 | 65 | 2 |
| other | Atrioventricular block first degree | Cardiac disorders | Age Cohort: ≥1 Month to <2 Years | 0 | 36 | 0 |
| other | Atrioventricular block first degree | Cardiac disorders | Age Cohort: ≥2 to <4 Years | 1 | 15 | 1 |
| other | Atrioventricular block first degree | Cardiac disorders | Age Cohort: ≥4 to <12 Years | 0 | 141 | 0 |
| other | Atrioventricular block first degree | Cardiac disorders | Age Cohort: ≥12 to <17 Years | 0 | 65 | 0 |
| other | Arnold-Chiari malformation | Congenital, familial and genetic disorders | Age Cohort: ≥1 Month to <2 Years | 0 | 36 | 0 |
| other | Arnold-Chiari malformation | Congenital, familial and genetic disorders | Age Cohort: ≥2 to <4 Years | 1 | 15 | 1 |
1 to 10 of 852Source ClinicalTrials.gov
See all 852 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Age Cohort: ≥1 Month to <2 Years | 2 | 36 |
| Total, all-cause mortality | Age Cohort: ≥2 to <4 Years | 2 | 15 |
| Total, all-cause mortality | Age Cohort: ≥4 to <12 Years | 2 | 141 |
| Total, all-cause mortality | Age Cohort: ≥12 to <17 Years | 1 | 65 |
| Total, other adverse events | Age Cohort: ≥1 Month to <2 Years | 30 | 36 |
| Total, other adverse events | Age Cohort: ≥2 to <4 Years | 13 | 15 |
| Total, other adverse events | Age Cohort: ≥4 to <12 Years | 120 | 141 |
| Total, other adverse events | Age Cohort: ≥12 to <17 Years | 51 | 65 |
| Total, serious adverse events | Age Cohort: ≥1 Month to <2 Years | 14 | 36 |
| Total, serious adverse events | Age Cohort: ≥2 to <4 Years | 8 | 15 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers3
The papers the trial lists on ClinicalTrials.gov.
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/NCT01364597
GET https://conductscience.org/api/trials/v1/NCT01364597/events?page=2