Trial · NCT01339559
Brivaracetam Safety and Efficacy Follow-up Study in Subjects With Epilepsy
NCT01339559, Phase 3, Completed, UCB BIOSCIENCES, Inc.; results first posted 2020-06-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Brivaracetam Safety and Efficacy Follow-up Study in Subjects With Epilepsy. Trials, record NCT01339559. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01339559
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Brivaracetam Safety and Efficacy Follow-up Study in Subjects With Epilepsy
- NCT number
- NCT01339559
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 767 participants, actual
- Lead sponsor
- UCB BIOSCIENCES, Inc.
- Conditions
- Epilepsy
- Interventions
- Brivaracetam
- First posted
- 2011-04-20
- Last updated
- 2021-08-17
- Other registries' IDs
- eudract:2010-020345-27
- Results first posted
- 2020-06-04
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) | From Entry Visit (Month 0) until the Last Visit (up to 84 months) | Treatment-emergent Adverse Events (TEAEs) were defined as those events which started on or after the date of first dose of investigational medicinal product (IMP), or events in which severity worsened on or after the date of first dose of study medication. The event does not necessarily have a causal relationship with that treatment or usage. |
| Primary | Percentage of Participants Who Withdrew Due to Adverse Events (AEs) | From Entry Visit (Month 0) until the Last Visit (up to 84 months) | An AE is any untoward medical occurrence in a participant or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage. |
| Primary | Percentage of Participants With at Least One Serious Adverse Event (SAE) | From Entry Visit (Month 0) until the Last Visit (up to 84 months) | A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: * Results in death * Is life-threatening * Requires in patient hospitalization or prolongation of existing hospitalization * Is a congenital anomaly or birth defect * Is as infection that requires treatment parenteral antibiotics * Other important medical events which based on medical or scientific judgement may jeopardize the patients or may require medical or surgical intervention to prevent any of the above. |
| Secondary | Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days During the Evaluation Period | From Baseline of the previous study until the Last Visit (up to 84 months) | 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. |
| Secondary | Percent Change in Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days From Baseline of the Previous Study to the Evaluation Period | From Baseline of the previous study until the Last Visit (up to 84 months) | The percent change from the previous study baselines, in Partial Onset Seizure (POS) (Type I) frequency per 28 days is defined as: (the value at the previous study baselines) minus (the value at each time-points during the evaluation period) divided by the value at the previous study baselines. Note: Since N01258 was a safety study, participants were not required to meet seizure frequency requirements during the Baseline Period, and the Baseline Period was short (ie, 7 days). Therefore, participants from N01258 were excluded from efficacy summaries in the variable of percent change in POS frequency. |
| Secondary | Responder Rate in POS (Type I) Frequency Over the Evaluation Period | From Baseline of the previous study until the Last Visit (up to 84 months) | A responder is defined as a subject with a ≥ 50% reduction in seizure frequency from the Baseline Period of the previous study. Note: Since N01258 was a safety study, participants were not required to meet seizure frequency requirements during the Baseline Period, and the Baseline Period was short (ie, 7 days). Therefore, participants from N01258 were excluded from efficacy summaries in the variable of responder rates in POS frequency. |
Source ClinicalTrials.gov
Outcomes6
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 at Least One Treatment-Emergent Adverse Event (TEAE) | From Entry Visit (Month 0) until the Last Visit (up to 84 months) | The Safety Set (SS) consisted of all participants who took at least 1 dose of study drug. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Who Withdrew Due to Adverse Events (AEs) | From Entry Visit (Month 0) until the Last Visit (up to 84 months) | The Safety Set (SS) consisted of all participants who took at least 1 dose of study drug. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With at Least One Serious Adverse Event (SAE) | From Entry Visit (Month 0) until the Last Visit (up to 84 months) | The Safety Set (SS) consisted of all participants who took at least 1 dose of study drug. | Percentage of participants | NUMBER |
| SECONDARY | Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days During the Evaluation Period | From Baseline of the previous study until the Last Visit (up to 84 months) | The Partial Onset Seizure (POS) Efficacy Analysis Set consisted of all subjects with POS who took at least 1 dose of study drug and had at least 1 seizure diary day during the Evaluation Period. | Seizures per 28 days | MEDIAN |
| SECONDARY | Percent Change in Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days From Baseline of the Previous Study to the Evaluation Period | From Baseline of the previous study until the Last Visit (up to 84 months) | The Partial Onset Seizure (POS) Efficacy Analysis Set consisted of all subjects with POS who took at least 1 dose of study drug and had at least 1 seizure diary day during the Evaluation Period.~Participants from N01258 were excluded from this analysis. | Percent change | MEDIAN |
| SECONDARY | Responder Rate in POS (Type I) Frequency Over the Evaluation Period | From Baseline of the previous study until the Last Visit (up to 84 months) | The Partial Onset Seizure (POS) Efficacy Analysis Set consisted of all subjects with POS who took at least 1 dose of study drug and had at least 1 seizure diary day during the Evaluation Period.~Participants from N01258 were excluded from this analysis. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group7
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 at Least One Treatment-Emergent Adverse Event (TEAE) | Brivaracetam (SS) | 83.9 | Percentage of participants | ||
| Percentage of Participants Who Withdrew Due to Adverse Events (AEs) | Brivaracetam (SS) | 11.9 | Percentage of participants | ||
| Percentage of Participants With at Least One Serious Adverse Event (SAE) | Brivaracetam (SS) | 18.4 | Percentage of participants | ||
| Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days During the Evaluation Period | Brivaracetam (POS Efficacy) | Baseline | 9.7 | Inter-Quartile Range 5.5 to 23.7 | Seizures per 28 days |
| Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days During the Evaluation Period | Brivaracetam (POS Efficacy) | On Treatment | 4.2 | Inter-Quartile Range 1.4 to 12.7 | Seizures per 28 days |
| Percent Change in Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days From Baseline of the Previous Study to the Evaluation Period | Brivaracetam (POS Efficacy) | 52.0 | Inter-Quartile Range 16.8 to 81.5 | Percent change | |
| Responder Rate in POS (Type I) Frequency Over the Evaluation Period | Brivaracetam (POS Efficacy) | 51.7 | Percentage of participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Brivaracetam | 766 | |
| Overall Study | COMPLETED | Brivaracetam | 368 | |
| Overall Study | NOT COMPLETED | Brivaracetam | 398 |
Source ClinicalTrials.gov
Adverse events159
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 | Brivaracetam (SS) | 59 | 766 | 67 |
| other | Nasopharyngitis | Infections and infestations | Brivaracetam (SS) | 65 | 766 | 102 |
| other | Upper respiratory tract infection | Infections and infestations | Brivaracetam (SS) | 59 | 766 | 101 |
| other | Urinary tract infection | Infections and infestations | Brivaracetam (SS) | 57 | 766 | 86 |
| other | Influenza | Infections and infestations | Brivaracetam (SS) | 40 | 766 | 47 |
| other | Contusion | Injury, poisoning and procedural complications | Brivaracetam (SS) | 44 | 766 | 71 |
| other | Fall | Injury, poisoning and procedural complications | Brivaracetam (SS) | 43 | 766 | 60 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Brivaracetam (SS) | 46 | 766 | 59 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Brivaracetam (SS) | 41 | 766 | 56 |
| other | Headache | Nervous system disorders | Brivaracetam (SS) | 102 | 766 | 187 |
1 to 10 of 159Source ClinicalTrials.gov
See all 159 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Brivaracetam (SS) | 5 | 766 |
| Total, other adverse events | Brivaracetam (SS) | 421 | 766 |
| Total, serious adverse events | Brivaracetam (SS) | 140 | 766 |
Source ClinicalTrials.gov
Papers4
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/NCT01339559
GET https://conductscience.org/api/trials/v1/NCT01339559/events?page=2