Trial · NCT00150800
This Trial, Evaluating the Long-term Safety and Tolerability of Brivaracetam Will Provide Subjects Suffering From Epilepsy, Who May Have Benefited From Brivaracetam as Adjunctive Treatment, the Opportunity to Receive Open Label Brivaracetam Treatment
NCT00150800, Phase 3, Completed, UCB PHARMA Inc. (US); results first posted 2018-12-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. This Trial, Evaluating the Long-term Safety and Tolerability of Brivaracetam Will Provide Subjects Suffering From Epilepsy, Who May Have Benefited From Brivaracetam as Adjunctive Treatment, the Opportunity to Receive Open Label Brivaracetam Treatment. Trials, record NCT00150800. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00150800
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
This Trial, Evaluating the Long-term Safety and Tolerability of Brivaracetam Will Provide Subjects Suffering From Epilepsy, Who May Have Benefited From Brivaracetam as Adjunctive Treatment, the Opportunity to Receive Open Label Brivaracetam Treatment
- NCT number
- NCT00150800
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 668 participants, actual
- Lead sponsor
- UCB PHARMA Inc. (US)
- Conditions
- Epilepsy
- Interventions
- Brivaracetam
- First posted
- 2005-09-08
- Last updated
- 2021-08-17
- Results first posted
- 2018-12-05
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) During the Study Period | Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years) | Treatment-Emergent Adverse Events (TEAEs) are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment. |
| Primary | Percentage of Participants Who Withdrew Due to an Adverse Event (AE) During the Study Period | Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years) | Adverse Events (AE) are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment. |
| Primary | Percentage of Participants With a Serious Adverse Event (SAE) During the Study Period | Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years) | A Serious Adverse Event (SAE) is any untoward medical incidence that occurs at any dose. |
| Secondary | Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days During the Evaluation Period | From Baseline of the previous study to the Evaluation Period (up to 11 years) | Baseline is the Baseline from subject's previous study of enrollment period. N01193 \[NCT00175825\], N01252 \[NCT00490035\], N01253 \[NCT00464269\], N01254 \[NCT00504881\]. A 28 day Type 1 seizure frequency is the total number of Type 1 seizures divided by the total number of days evaluated multiplied 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 to the Evaluation Period (up to 11 years) | 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. |
| Secondary | Percentage of Participants With Response for Partial Onset Seizure (POS) (Type I) Frequency Over the Evaluation Period | From Baseline of the previous study to the Evaluation Period (up to 11 years) | A responder is defined as a subject with a higher than or equal to (\>=) 50 % change in seizure frequency from Baseline period of the previous study. |
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) During the Study Period | Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years) | The Safety Analysis Set consisted of all subjects who took at least 1 dose of study drug. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Who Withdrew Due to an Adverse Event (AE) During the Study Period | Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years) | The Safety Analysis Set consisted of all subjects who took at least 1 dose of study drug. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With a Serious Adverse Event (SAE) During the Study Period | Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years) | The Safety Analysis Set consisted of all subjects 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 to the Evaluation Period (up to 11 years) | 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 to the Evaluation Period (up to 11 years) | The Partial Onset Seizures (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. | percent change | MEDIAN |
| SECONDARY | Percentage of Participants With Response for Partial Onset Seizure (POS) (Type I) Frequency Over the Evaluation Period | From Baseline of the previous study to the Evaluation Period (up to 11 years) | The Partial Onset Seizures (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. | 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) During the Study Period | Brivaracetam (SS) | 91.2 | percentage of participants | ||
| Percentage of Participants Who Withdrew Due to an Adverse Event (AE) During the Study Period | Brivaracetam (SS) | 14.8 | percentage of participants | ||
| Percentage of Participants With a Serious Adverse Event (SAE) During the Study Period | Brivaracetam (SS) | 22.8 | percentage of participants | ||
| Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days During the Evaluation Period | Brivaracetam (POS-ES) | baseline | 9.2 | Inter-Quartile Range 5.5 to 20.2 | Seizures per 28 days |
| Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days During the Evaluation Period | Brivaracetam (POS-ES) | on treatment | 4.2 | Inter-Quartile Range 1.6 to 11.3 | 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-ES) | 57.3 | Inter-Quartile Range 18.6 to 82.2 | percent change | |
| Percentage of Participants With Response for Partial Onset Seizure (POS) (Type I) Frequency Over the Evaluation Period | Brivaracetam (POS-ES) | 55.6 | 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 | 667 | |
| Overall Study | COMPLETED | Brivaracetam | 171 | |
| Overall Study | NOT COMPLETED | Brivaracetam | 496 |
Source ClinicalTrials.gov
Adverse events204
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 | Nausea | Gastrointestinal disorders | Brivaracetam | 67 | 667 | 93 |
| other | Diarrhoea | Gastrointestinal disorders | Brivaracetam | 65 | 667 | 86 |
| other | Vomiting | Gastrointestinal disorders | Brivaracetam | 58 | 667 | 109 |
| other | Toothache | Gastrointestinal disorders | Brivaracetam | 42 | 667 | 66 |
| other | Abdominal pain | Gastrointestinal disorders | Brivaracetam | 39 | 667 | 55 |
| other | Constipation | Gastrointestinal disorders | Brivaracetam | 38 | 667 | 48 |
| other | Pyrexia | General disorders | Brivaracetam | 69 | 667 | 132 |
| other | Fatigue | General disorders | Brivaracetam | 51 | 667 | 63 |
| other | Irritability | General disorders | Brivaracetam | 42 | 667 | 50 |
| other | Nasopharyngitis | Infections and infestations | Brivaracetam | 94 | 667 | 154 |
1 to 10 of 204Source ClinicalTrials.gov
See all 204 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Brivaracetam | 18 | 667 |
| Total, other adverse events | Brivaracetam | 521 | 667 |
| Total, serious adverse events | Brivaracetam | 152 | 667 |
Source ClinicalTrials.gov
Papers3
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/NCT00150800
GET https://conductscience.org/api/trials/v1/NCT00150800/events?page=2