Trial · NCT01261325
Brivaracetam Efficacy and Safety Study in Subjects With Partial Onset Seizures
NCT01261325, Phase 3, Completed, UCB Pharma; results first posted 2016-08-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Brivaracetam Efficacy and Safety Study in Subjects With Partial Onset Seizures. Trials, record NCT01261325. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01261325
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Brivaracetam Efficacy and Safety Study in Subjects With Partial Onset Seizures
- NCT number
- NCT01261325
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 768 participants, actual
- Lead sponsor
- UCB Pharma
- Conditions
- Epilepsy
- Interventions
- Placebo, Brivaracetam, Brivaracetam, Antiepileptic drugs with market authorization available per country
- First posted
- 2010-12-16
- Last updated
- 2022-07-22
- Other registries' IDs
- eudract:2010-019361-28
- Results first posted
- 2016-08-15
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Reduction Over Placebo for Partial Onset Seizure (Type I) Frequency Over the Treatment Period Standardized to a 28-day Duration | 12 week Treatment Period | Primary endpoint: United States of America (FDA) |
| Primary | 50% Responder Rate for Partial Onset Seizure (Type I) Frequency Over the Treatment Period Standardized to a 28-day Duration | Baseline to 12 week Treatment Period | Primary Endpoint: European Regulatory Authorities A responder is a participant who experienced a 50% or greater reduction in partial onset seizure (Type I) frequency over the Treatment Period standardized to a 28-day duration. |
| Secondary | Percent Change in Partial Onset Seizure (Type I) Frequency From the Baseline to the Treatment Period | Baseline to 12 week Treatment Period | |
| Secondary | Categorized Percent Reduction Form Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the Treatment Period | Baseline to 12 week Treatment Period | |
| Secondary | Seizure Freedom Rate (All Seizure Types) During the 12-week Treatment Period | 12 week Treatment Period | |
| Secondary | All Seizure Frequency (Type I + II + III) During the 12-week Treatment Period | 12 week Treatment Period | |
| Secondary | Time to the First Type I Seizure During the Treatment Period | 12 week Treatment Period | |
| Secondary | Time to the Fifth Type I Seizure During the Treatment Period | 12 week Treatment Period | |
| Secondary | Time to the Tenth Type I Seizure During the Treatment Period | 12 week Treatment Period |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Reduction Over Placebo for Partial Onset Seizure (Type I) Frequency Over the Treatment Period Standardized to a 28-day Duration | 12 week Treatment Period | Analysis population consists of the Intent-to-Treat (ITT) Population, which is all randomized subjects who received at least 1 dose of study medication and have at least 1 post-Baseline seizure diary. | Percentage of reduction | NUMBER |
| PRIMARY | 50% Responder Rate for Partial Onset Seizure (Type I) Frequency Over the Treatment Period Standardized to a 28-day Duration | Baseline to 12 week Treatment Period | Analysis population consists of the Intent-to-Treat (ITT) Population, which is all randomized subjects who received at least 1 dose of study medication and have at least 1 post-Baseline seizure diary. | Percentage of subjects | NUMBER |
| SECONDARY | Percent Change in Partial Onset Seizure (Type I) Frequency From the Baseline to the Treatment Period | Baseline to 12 week Treatment Period | Analysis population consists of the Intent-to-Treat (ITT) Population, which is all randomized subjects who received at least 1 dose of study medication and have at least 1 post-Baseline seizure diary. | percentage of change | MEDIAN |
| SECONDARY | Categorized Percent Reduction Form Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the Treatment Period | Baseline to 12 week Treatment Period | Analysis population consists of the Intent-to-Treat (ITT) Population, which is all randomized subjects who received at least 1 dose of study medication and have at least 1 post-Baseline seizure diary. | percentage of subjects | NUMBER |
| SECONDARY | Seizure Freedom Rate (All Seizure Types) During the 12-week Treatment Period | 12 week Treatment Period | Analysis population consists of the Intent-to-Treat (ITT) Population, which is all randomized subjects who received at least 1 dose of study medication and have at least 1 post-Baseline seizure diary. | percentage of subjects | NUMBER |
| SECONDARY | All Seizure Frequency (Type I + II + III) During the 12-week Treatment Period | 12 week Treatment Period | Analysis population consists of the Intent-to-Treat (ITT) Population, which is all randomized subjects who received at least 1 dose of study medication and have at least 1 post-Baseline seizure diary. | number of seizures/ 28-day | MEDIAN |
| SECONDARY | Time to the First Type I Seizure During the Treatment Period | 12 week Treatment Period | Analysis population consists of the Intent-to-Treat (ITT) Population, which is all randomized subjects who received at least 1 dose of study medication and have at least 1 post-Baseline seizure diary. | days | MEDIAN |
| SECONDARY | Time to the Fifth Type I Seizure During the Treatment Period | 12 week Treatment Period | days | MEDIAN | |
| SECONDARY | Time to the Tenth Type I Seizure During the Treatment Period | 12 week Treatment Period | days | MEDIAN |
Source ClinicalTrials.gov
Results by group51
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Reduction Over Placebo for Partial Onset Seizure (Type I) Frequency Over the Treatment Period Standardized to a 28-day Duration | Brivaracetam 100 mg/Day | 22.8 | Percentage of reduction | ||
| Percent Reduction Over Placebo for Partial Onset Seizure (Type I) Frequency Over the Treatment Period Standardized to a 28-day Duration | Brivaracetam 200 mg/Day | 23.2 | Percentage of reduction | ||
| Percent Reduction Over Placebo for Partial Onset Seizure (Type I) Frequency Over the Treatment Period Standardized to a 28-day Duration | Placebo | 0 | Percentage of reduction | ||
| 50% Responder Rate for Partial Onset Seizure (Type I) Frequency Over the Treatment Period Standardized to a 28-day Duration | Placebo | Responders | 21.6 | Percentage of subjects | |
| 50% Responder Rate for Partial Onset Seizure (Type I) Frequency Over the Treatment Period Standardized to a 28-day Duration | Brivaracetam 100 mg/Day | Responders | 38.9 | Percentage of subjects | |
| 50% Responder Rate for Partial Onset Seizure (Type I) Frequency Over the Treatment Period Standardized to a 28-day Duration | Brivaracetam 200 mg/Day | Responders | 37.8 | Percentage of subjects | |
| 50% Responder Rate for Partial Onset Seizure (Type I) Frequency Over the Treatment Period Standardized to a 28-day Duration | Placebo | Non-Responders | 78.4 | Percentage of subjects | |
| 50% Responder Rate for Partial Onset Seizure (Type I) Frequency Over the Treatment Period Standardized to a 28-day Duration | Brivaracetam 100 mg/Day | Non-Responders | 61.1 | Percentage of subjects | |
| 50% Responder Rate for Partial Onset Seizure (Type I) Frequency Over the Treatment Period Standardized to a 28-day Duration | Brivaracetam 200 mg/Day | Non-Responders | 62.2 | Percentage of subjects | |
| Percent Change in Partial Onset Seizure (Type I) Frequency From the Baseline to the Treatment Period | Placebo | 17.6 | Inter-Quartile Range -8.3 to 46.0 | percentage of change |
1 to 10 of 51Source ClinicalTrials.gov
See all 51 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 263 | |
| Overall Study | STARTED | Brivaracetam 100 mg/Day | 254 | |
| Overall Study | STARTED | Brivaracetam 200 mg/Day | 251 | |
| Overall Study | COMPLETED | Placebo | 246 | |
| Overall Study | COMPLETED | Brivaracetam 100 mg/Day | 225 | |
| Overall Study | COMPLETED | Brivaracetam 200 mg/Day | 225 | |
| Overall Study | NOT COMPLETED | Placebo | 17 | |
| Overall Study | NOT COMPLETED | Brivaracetam 100 mg/Day | 29 | |
| Overall Study | NOT COMPLETED | Brivaracetam 200 mg/Day | 26 |
Source ClinicalTrials.gov
Adverse events93
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 | Fatigue | General disorders | Placebo | 10 | 261 | 10 |
| other | Fatigue | General disorders | Brivaracetam 100 mg/Day | 19 | 253 | 19 |
| other | Fatigue | General disorders | Brivaracetam 200 mg/Day | 29 | 250 | 32 |
| other | Urinary tract infection | Infections and infestations | Placebo | 8 | 261 | 8 |
| other | Urinary tract infection | Infections and infestations | Brivaracetam 100 mg/Day | 13 | 253 | 13 |
| other | Urinary tract infection | Infections and infestations | Brivaracetam 200 mg/Day | 2 | 250 | 2 |
| other | Somnolence | Nervous system disorders | Placebo | 20 | 261 | 20 |
| other | Somnolence | Nervous system disorders | Brivaracetam 100 mg/Day | 49 | 253 | 53 |
| other | Somnolence | Nervous system disorders | Brivaracetam 200 mg/Day | 42 | 250 | 43 |
| other | Dizziness | Nervous system disorders | Placebo | 13 | 261 | 14 |
1 to 10 of 93Source ClinicalTrials.gov
See all 93 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Brivaracetam 100 mg/Day | ||
| Total, all-cause mortality | Brivaracetam 200 mg/Day | ||
| Total, other adverse events | Placebo | 61 | 261 |
| Total, other adverse events | Brivaracetam 100 mg/Day | 96 | 253 |
| Total, other adverse events | Brivaracetam 200 mg/Day | 97 | 250 |
| Total, serious adverse events | Placebo | 9 | 261 |
| Total, serious adverse events | Brivaracetam 100 mg/Day | 8 | 253 |
| Total, serious adverse events | Brivaracetam 200 mg/Day | 8 | 250 |
Source ClinicalTrials.gov
Papers19
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/NCT01261325
GET https://conductscience.org/api/trials/v1/NCT01261325/results?page=2