Trial · NCT00504881
Brivaracetam as add-on Treatment in Adolescents and Adults Suffering From Epilepsy
NCT00504881, Phase 3, Completed, UCB Pharma SA; results first posted 2017-03-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Brivaracetam as add-on Treatment in Adolescents and Adults Suffering From Epilepsy. Trials, record NCT00504881. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00504881
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Brivaracetam as add-on Treatment in Adolescents and Adults Suffering From Epilepsy
- NCT number
- NCT00504881
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 480 participants, actual
- Lead sponsor
- UCB Pharma SA
- Conditions
- Epilepsy
- Interventions
- Placebo, Brivaracetam
- First posted
- 2007-07-20
- Last updated
- 2018-04-03
- Other registries' IDs
- eudract:2006-006346-34
- Results first posted
- 2017-03-17
Source ClinicalTrials.gov
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Subjects With at Least One Adverse Event During the 16-week Treatment Period | Week 2 to the end of the Treatment Period (Week 16) | An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. |
| Primary | Partial Onset Seizure (Type I) Frequency Per Week Over the 16-week Treatment Period | Baseline (Week 0) to the end of the Treatment Period (Week 16) | Partial (Type I) seizures can be classified into one of the following three groups: * Simple partial seizures * Complex partial seizures * Partial seizures evolving to generalized tonic-clonic convulsions. Partial Onset Seizure (POS) frequency per week over the Treatment Period (TP) was calculated as: (Total Type I seizures over the TP)\*7/(Total number of days with no missing seizure count in the TP) |
| Secondary | Responder Rate for Partial Onset Seizures (Type I) Frequency Per Week Over the 16-week Treatment Period | Baseline (Week 0) to the end of Treatment Period (Week 16) | The responder rate was presented as the percentage of responders and non-responders. A subject is a responder, if the subject has at least 50 % reduction in Partial Onset Seizure frequency per week from Baseline to Treatment Period. Subjects with zero seizure frequency per week at Baseline were considered as non-responders. |
| Secondary | Seizure Frequency (All Seizure Types) Per Week Over the 16-week Treatment Period | Baseline (Week 0) to the end of Treatment Period (Week 16) | There are three different types of seizures: * Type I: Partial seizures * Type II: Generalized seizures * Type III: Unclassified epileptic seizures. All seizure frequency per week over Treatment Period (TP) was calculated as: (Total number of seizures over the TP)\*7/(Total number of days with no missing seizure count in the TP) |
| Secondary | Percent Change From Baseline to the 16-week Treatment Period in Partial Onset Seizure (Type I) Frequency Per Week | Baseline (Week 0) to end of Treatment Period (Week 16) | Percent change from Baseline was calculated as percent reduction by: (weekly seizure frequency Baseline - weekly seizure frequency Treatment)\*100/(weekly seizure frequency Baseline). A negative value in percent Change from Baseline indicates an improvement from Baseline. The higher the negative values for percent change in Partial Onset Seizure (POS) frequency, the higher the improvement from Baseline. |
| Secondary | Categorized Response From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 16-week Treatment Period | Baseline to 16-week Treatment Period | Subjects were classified in 1 of the following categories based on their percent reduction from Baseline to Treatment Period in Partial Onset Seizure (POS) frequency per week: \<-25 %, -25 % to \<25 %, 25 % to \<50 %, 50 % to \<75 %, 75 % to \<100 %, and 100 %. Subjects having zero for Baseline seizure frequency per week were classified in the \<-25 % category. |
| Secondary | Seizure Freedom Rate (All Seizure Types) Over the 16-week Treatment Period | Baseline (Week 0) to the end of Treatment Period (Week 16) | Subjects were considered seizure free if their seizure counts for every day over the Treatment Period (TP) was zero and if they did not discontinue before the end of the TP. Seizure freedom rate was calculated as: (total number of seizure - free subjects in treatment group during TP)/(total number of evaluable Intent-To-Treat (ITT) subjects in treatment group) |
| Secondary | Reduction of Type IC/Type I Seizure Frequency Ratio From Baseline to the 16-week Treatment Period | Baseline to 16-week Treatment Period | The type IC/Type I seizure frequency ratio is represented by the percentage of subjects having a reduction in the ratio of Type IC seizure frequency over Type IA, IB, and IC seizure frequency from Baseline to Treatment Period. |
| Secondary | Time to First Type I Seizure During the 16-week Treatment Period | Baseline to 16-week Treatment Period | Time to first Type I seizure during the 16-week Treatment Period was measured in days. |
| Secondary | Time to Fifth Type I Seizure During the 16-week Treatment Period | Baseline to 16-week Treatment Period | Time to fifth Type I seizure during the 16-week Treatment Period was measured in days. |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 registered outcomesOutcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Subjects With at Least One Adverse Event During the 16-week Treatment Period | Week 2 to the end of the Treatment Period (Week 16) | The Safety Population was defined as all randomized subjects who received at least 1 dose of study medication. | percentage of participants | NUMBER |
| PRIMARY | Partial Onset Seizure (Type I) Frequency Per Week Over the 16-week Treatment Period | Baseline (Week 0) to the end of the Treatment Period (Week 16) | Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication. | seizures per week | MEDIAN |
| SECONDARY | Responder Rate for Partial Onset Seizures (Type I) Frequency Per Week Over the 16-week Treatment Period | Baseline (Week 0) to the end of Treatment Period (Week 16) | Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication. | percentage of participants | NUMBER |
| SECONDARY | Seizure Frequency (All Seizure Types) Per Week Over the 16-week Treatment Period | Baseline (Week 0) to the end of Treatment Period (Week 16) | Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication. | number of seizures per week | MEDIAN |
| SECONDARY | Percent Change From Baseline to the 16-week Treatment Period in Partial Onset Seizure (Type I) Frequency Per Week | Baseline (Week 0) to end of Treatment Period (Week 16) | Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication. | percent change | MEDIAN |
| SECONDARY | Categorized Response From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 16-week Treatment Period | Baseline to 16-week Treatment Period | Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication. | percentage of participants | NUMBER |
| SECONDARY | Seizure Freedom Rate (All Seizure Types) Over the 16-week Treatment Period | Baseline (Week 0) to the end of Treatment Period (Week 16) | Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication. | percentage of participants | NUMBER |
| SECONDARY | Reduction of Type IC/Type I Seizure Frequency Ratio From Baseline to the 16-week Treatment Period | Baseline to 16-week Treatment Period | The Intention-to-treat (ITT) population was defined as all randomized subjects who received at least 1 dose of study medication.~Type IC Population consists of those subjects with at least one Type IC seizure during the Baseline period. | percentage of participants | NUMBER |
| SECONDARY | Time to First Type I Seizure During the 16-week Treatment Period | Baseline to 16-week Treatment Period | Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication. | days | MEDIAN |
| SECONDARY | Time to Fifth Type I Seizure During the 16-week Treatment Period | Baseline to 16-week Treatment Period | Localization-related epilepsy Intent-To-Treat (ITT) Population (POS). The ITT Population was defined as all randomized subjects who received at least 1 dose of study medication. | days | MEDIAN |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 outcomesResults by group62
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Subjects With at Least One Adverse Event During the 16-week Treatment Period | Placebo | 66.1 | percentage of participants | ||
| Percentage of Subjects With at Least One Adverse Event During the 16-week Treatment Period | Brivaracetam | 66.6 | percentage of participants | ||
| Partial Onset Seizure (Type I) Frequency Per Week Over the 16-week Treatment Period | Placebo | 1.86 | Inter-Quartile Range 1.00 to 3.98 | seizures per week | |
| Partial Onset Seizure (Type I) Frequency Per Week Over the 16-week Treatment Period | Brivaracetam | 1.74 | Inter-Quartile Range 0.86 to 4.04 | seizures per week | |
| Responder Rate for Partial Onset Seizures (Type I) Frequency Per Week Over the 16-week Treatment Period | Placebo | Responders | 16.7 | percentage of participants | |
| Responder Rate for Partial Onset Seizures (Type I) Frequency Per Week Over the 16-week Treatment Period | Brivaracetam | Responders | 30.3 | percentage of participants | |
| Responder Rate for Partial Onset Seizures (Type I) Frequency Per Week Over the 16-week Treatment Period | Placebo | Non-Responders | 83.3 | percentage of participants | |
| Responder Rate for Partial Onset Seizures (Type I) Frequency Per Week Over the 16-week Treatment Period | Brivaracetam | Non-Responders | 69.7 | percentage of participants | |
| Seizure Frequency (All Seizure Types) Per Week Over the 16-week Treatment Period | Placebo | 1.87 | Inter-Quartile Range 1.00 to 4.59 | number of seizures per week | |
| Seizure Frequency (All Seizure Types) Per Week Over the 16-week Treatment Period | Brivaracetam | 1.74 | Inter-Quartile Range 0.86 to 4.04 | number of seizures per week |
1 to 10 of 62Source ClinicalTrials.gov
See all 62 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 121 | |
| Overall Study | STARTED | Brivaracetam | 359 | |
| Overall Study | COMPLETED | Placebo | 111 | |
| Overall Study | COMPLETED | Brivaracetam | 323 | |
| Overall Study | NOT COMPLETED | Placebo | 10 | |
| Overall Study | NOT COMPLETED | Brivaracetam | 36 |
Source ClinicalTrials.gov
Adverse events70
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 | Nasopharyngitis | Infections and infestations | Placebo | 8 | 121 | 10 |
| other | Nasopharyngitis | Infections and infestations | Brivaracetam | 14 | 359 | 16 |
| other | Nausea | Gastrointestinal disorders | Placebo | 11 | 121 | 14 |
| other | Nausea | Gastrointestinal disorders | Brivaracetam | 20 | 359 | 26 |
| other | Fatigue | General disorders | Placebo | 5 | 121 | 5 |
| other | Fatigue | General disorders | Brivaracetam | 27 | 359 | 31 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Placebo | 8 | 121 | 9 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Brivaracetam | 11 | 359 | 11 |
| other | Dizziness | Nervous system disorders | Placebo | 7 | 121 | 9 |
| other | Dizziness | Nervous system disorders | Brivaracetam | 31 | 359 | 36 |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Brivaracetam | ||
| Total, other adverse events | Placebo | 40 | 121 |
| Total, other adverse events | Brivaracetam | 139 | 359 |
| Total, serious adverse events | Placebo | 9 | 121 |
| Total, serious adverse events | Brivaracetam | 20 | 359 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Brivaracetam vs Placebo: serious adverse events |
Source Trial comparisons
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/NCT00504881
GET https://conductscience.org/api/trials/v1/NCT00504881/registered?page=2