Trial · NCT00175825
A Dose-ranging Study With Brivaracetam in Patients From 16 to 65 Years With Refractory Partial Onset Seizures.
NCT00175825, Phase 2, Completed, UCB Pharma; results first posted 2018-08-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Dose-ranging Study With Brivaracetam in Patients From 16 to 65 Years With Refractory Partial Onset Seizures. Trials, record NCT00175825. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00175825
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Dose-ranging Study With Brivaracetam in Patients From 16 to 65 Years With Refractory Partial Onset Seizures.
- NCT number
- NCT00175825
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 210 participants, actual
- Lead sponsor
- UCB Pharma
- Conditions
- Epilepsy
- Interventions
- Placebo, Brivaracetam
- First posted
- 2005-09-15
- Last updated
- 2018-10-02
- Results first posted
- 2018-08-22
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Partial Onset Seizure Frequency Per Week During the 7-week Treatment Period | During the 7-week Treatment Period | Calculated as 7-day partial onset seizure frequency. |
| Secondary | Percentage Change From Baseline in Partial Onset Seizure Frequency Per Week (Type I) Over the 7-week Treatment Period | Baseline, during the 7-week Treatment Period | Calculated as 7-day seizure frequency during the 7-week Treatment Period - 7-day seizure frequency during the Baseline Period, divided by the 7-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in partial seizure frequency from Baseline. |
| Secondary | Seizure Frequency Per Week for All Seizures (Types I +II +III) Over the Treatment Period | During the 7-week Treatment Period | Types I+II+III seizure frequency (Type I: Partial (focal, local), Type II: Generalized (convulsive or nonconvulsive), Type III: Unclassified) per week will be derived from the seizure count information recorded on the daily record card (e.g. date, number, type of epileptic seizures) and is defined as the number of seizures standardized to a 7-day period. |
| Secondary | Absolute Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) Over the Treatment Period | During the 7-week Treatment Period | Calculated as 7-day Partial Onset Seizures (Type I) frequency during the 7-week Treatment Period 7-day seizure frequency during the Baseline Period. A negative value from Baseline indicates a decrease in partial seizure frequency from Baseline. |
| Secondary | Absolute Change From Baseline in Seizure Frequency Per Week for All Seizures (Types I + II + III) Over the Treatment Period | During the 7-week Treatment Period | Calculated as 7-day seizure frequency during the 7-week Treatment Period 7-day seizure (Types I + II + III) frequency during the Baseline Period. A negative value from Baseline indicates a decrease in partial seizure frequency from Baseline. |
| Secondary | Percentage Change From Baseline in Seizure Frequency Per Week for All Seizures (Types I + II + III) Over the Treatment Period | During the 7-week Treatment Period | Calculated as 7-day seizure frequency during the 7-week Treatment Period - 7-day seizure frequency during the Baseline Period, divided by the 7-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in partial seizure frequency from Baseline. |
| Secondary | Responder Rate in Partial Onset Seizures (Type I) Over the Treatment Period | During the 7-week Treatment Period | A responder was defined as a subject with a \>= 50 % reduction in seizure frequency per week from the Baseline Period to the end of the Treatment Period. |
| Secondary | Percentage of Subjects With Categorized Response to the Treatment in Partial Onset Seizures (Type I) Over the Treatment Period | During the 7-week Treatment Period | Categories of percentage reductions in seizures from baseline were as following: \< -25 %; -25 % to \<25 %; 25 % to \<75 %; 75 % to \<100 %; 100 %. |
| Secondary | Percentage of Subjects Who Are Seizure Free During the 7-week Treatment Period | During the 7-week Treatment Period | A subject was considered seizure free, if no seizure was reported during the 7-week Treatment Period. |
| Secondary | Number of Seizure-free Days Per 4 Weeks | Baseline, during the 7-week Treatment Period | A day was considered seizure-free, if no seizure was reported during 24 hours. |
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 |
|---|---|---|---|---|---|
| SECONDARY | Percentage Change From Baseline in Partial Onset Seizure Frequency Per Week (Type I) Over the 7-week Treatment Period | Baseline, during the 7-week Treatment Period | percentage of change | MEDIAN | |
| SECONDARY | Seizure Frequency Per Week for All Seizures (Types I +II +III) Over the Treatment Period | During the 7-week Treatment Period | seizures per week | MEDIAN | |
| SECONDARY | Absolute Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) Over the Treatment Period | During the 7-week Treatment Period | seizures per week | MEDIAN | |
| SECONDARY | Absolute Change From Baseline in Seizure Frequency Per Week for All Seizures (Types I + II + III) Over the Treatment Period | During the 7-week Treatment Period | seizures per week | MEDIAN | |
| SECONDARY | Percentage Change From Baseline in Seizure Frequency Per Week for All Seizures (Types I + II + III) Over the Treatment Period | During the 7-week Treatment Period | percentage of change | MEDIAN | |
| SECONDARY | Responder Rate in Partial Onset Seizures (Type I) Over the Treatment Period | During the 7-week Treatment Period | percentage of participants | NUMBER | |
| SECONDARY | Percentage of Subjects With Categorized Response to the Treatment in Partial Onset Seizures (Type I) Over the Treatment Period | During the 7-week Treatment Period | percentage of participants | NUMBER | |
| SECONDARY | Percentage of Subjects Who Are Seizure Free During the 7-week Treatment Period | During the 7-week Treatment Period | percentage of participants | NUMBER | |
| SECONDARY | Number of Seizure-free Days Per 4 Weeks | Baseline, during the 7-week Treatment Period | Days/4 Weeks | MEDIAN | |
| SECONDARY | Time to Nth (n= 1, 5, 10) Seizure During the 7-week Treatment Period | During the 7-week Treatment Period | days | MEDIAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group76
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage Change From Baseline in Partial Onset Seizure Frequency Per Week (Type I) Over the 7-week Treatment Period | Placebo | -21.7 | Inter-Quartile Range -42.99 to 12.04 | percentage of change | |
| Percentage Change From Baseline in Partial Onset Seizure Frequency Per Week (Type I) Over the 7-week Treatment Period | Brivaracetam 5 mg/Day | -29.91 | Inter-Quartile Range -53.33 to -3.83 | percentage of change | |
| Percentage Change From Baseline in Partial Onset Seizure Frequency Per Week (Type I) Over the 7-week Treatment Period | Brivaracetam 20 mg/Day | -42.56 | Inter-Quartile Range -67.92 to 0.44 | percentage of change | |
| Percentage Change From Baseline in Partial Onset Seizure Frequency Per Week (Type I) Over the 7-week Treatment Period | Brivaracetam 50 mg/Day | -53.04 | Inter-Quartile Range -69.33 to -19.56 | percentage of change | |
| Seizure Frequency Per Week for All Seizures (Types I +II +III) Over the Treatment Period | Placebo | Baseline | 2.23 | Inter-Quartile Range 1.30 to 4.22 | seizures per week |
| Seizure Frequency Per Week for All Seizures (Types I +II +III) Over the Treatment Period | Brivaracetam 5 mg/Day | Baseline | 2.21 | Inter-Quartile Range 1.38 to 5.00 | seizures per week |
| Seizure Frequency Per Week for All Seizures (Types I +II +III) Over the Treatment Period | Brivaracetam 20 mg/Day | Baseline | 2.50 | Inter-Quartile Range 1.50 to 6.06 | seizures per week |
| Seizure Frequency Per Week for All Seizures (Types I +II +III) Over the Treatment Period | Brivaracetam 50 mg/Day | Baseline | 1.99 | Inter-Quartile Range 1.36 to 3.97 | seizures per week |
| Seizure Frequency Per Week for All Seizures (Types I +II +III) Over the Treatment Period | Placebo | Treatment | 1.81 | Inter-Quartile Range 0.88 to 3.50 | seizures per week |
| Seizure Frequency Per Week for All Seizures (Types I +II +III) Over the Treatment Period | Brivaracetam 5 mg/Day | Treatment | 1.61 | Inter-Quartile Range 0.75 to 4.34 | seizures per week |
1 to 10 of 76Source ClinicalTrials.gov
See all 76 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 54 | |
| Overall Study | STARTED | Brivaracetam 5 mg/Day | 50 | |
| Overall Study | STARTED | Brivaracetam 20 mg/Day | 52 | |
| Overall Study | STARTED | Brivaracetam 50 mg/Day | 52 | |
| Overall Study | COMPLETED | Placebo | 49 | |
| Overall Study | COMPLETED | Brivaracetam 5 mg/Day | 46 | |
| Overall Study | COMPLETED | Brivaracetam 20 mg/Day | 51 | |
| Overall Study | COMPLETED | Brivaracetam 50 mg/Day | 51 | |
| Overall Study | NOT COMPLETED | Placebo | 5 | |
| Overall Study | NOT COMPLETED | Brivaracetam 5 mg/Day | 4 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events28
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 | Neutropenia | Blood and lymphatic system disorders | Placebo | 1 | 54 | |
| other | Neutropenia | Blood and lymphatic system disorders | Brivaracetam 5 mg/Day | 4 | 50 | |
| other | Neutropenia | Blood and lymphatic system disorders | Brivaracetam 20 mg/Day | 2 | 52 | |
| other | Neutropenia | Blood and lymphatic system disorders | Brivaracetam 50 mg/Day | 1 | 52 | |
| other | Fatigue | General disorders | Placebo | 2 | 54 | |
| other | Fatigue | General disorders | Brivaracetam 5 mg/Day | 0 | 50 | |
| other | Fatigue | General disorders | Brivaracetam 20 mg/Day | 2 | 52 | |
| other | Fatigue | General disorders | Brivaracetam 50 mg/Day | 3 | 52 | |
| other | Influenza | Infections and infestations | Placebo | 4 | 54 | |
| other | Influenza | Infections and infestations | Brivaracetam 5 mg/Day | 4 | 50 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 54 |
| Total, all-cause mortality | Brivaracetam 5 mg/Day | 0 | 50 |
| Total, all-cause mortality | Brivaracetam 20 mg/Day | 0 | 52 |
| Total, all-cause mortality | Brivaracetam 50 mg/Day | 0 | 52 |
| Total, other adverse events | Placebo | 15 | 54 |
| Total, other adverse events | Brivaracetam 5 mg/Day | 13 | 50 |
| Total, other adverse events | Brivaracetam 20 mg/Day | 8 | 52 |
| Total, other adverse events | Brivaracetam 50 mg/Day | 10 | 52 |
| Total, serious adverse events | Placebo | 0 | 54 |
| Total, serious adverse events | Brivaracetam 5 mg/Day | 0 | 50 |
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.
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