Trial · NCT00368251
Brivaracetam as add-on Treatment of Unverricht-Lundborg Disease (ULD) in Adolescents and Adults
NCT00368251, Phase 3, Completed, UCB Pharma; results first posted 2016-04-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Brivaracetam as add-on Treatment of Unverricht-Lundborg Disease (ULD) in Adolescents and Adults. Trials, record NCT00368251. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00368251
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Brivaracetam as add-on Treatment of Unverricht-Lundborg Disease (ULD) in Adolescents and Adults
- NCT number
- NCT00368251
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 56 participants, actual
- Lead sponsor
- UCB Pharma
- Conditions
- Unverricht-Lundborg Disease
- Interventions
- Placebo, BRV 2.5 mg, BRV 25 mg, BRV 50 mg
- First posted
- 2006-08-24
- Last updated
- 2023-05-31
- Other registries' IDs
- eudract:2006-001536-46
- Results first posted
- 2016-04-13
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline to the End of Treatment Period on the Action Myoclonus Score (Unified Myoclonus Rating Scale (UMRS) Section 4) | From Baseline to End of Treatment Period (Week 14 or Early Discontinuation Visit) | The range for Action Myoclonus Score (centrally read) is 0 (best) - 160 (worst). Percent change from Baseline = 100 X ((Baseline UMRS4 - Treatment UMRS4) / Baseline UMRS4). Baseline is defined as the last non-missing value prior to or on Randomization Visit. |
| Secondary | Percent Change From Baseline to the End of Treatment Period on the Functional Disability Score (Unified Myoclonus Rating Scale (UMRS) Section 5) | Baseline to End of Treatment Period (Week 14 or Early Discontinuation Visit) | The range for Functional Disability Score is 0 (best) to 28 (worst). Percent change from Baseline = 100 X ((Baseline UMRS5 - Treatment UMRS5) / Baseline UMRS5). Baseline is defined as the last non-missing value prior to or on Randomization Visit. |
| Secondary | Percent Change From Baseline to the End of Treatment Period on the Stimulus Sensitivity Score (Unified Myoclonus Rating Scale (UMRS) Section 3) | Baseline to End of Treatment Period (Week 14 or Early Discontinuation Visit) | The range for Stimulus Sensitivity Score is 0 (best) to 17 (worst). Percent change from Baseline = 100 X ((Baseline UMRS3 - Treatment UMRS3) / Baseline UMRS3). Baseline is defined as the last non-missing value prior to or on Randomization Visit. |
| Secondary | Percent Change From Baseline to the End of Treatment Period on the Myoclonus Patient Questionnaire (Unified Myoclonus Rating Scale (UMRS) Section 1) | Baseline to End of Treatment Period (Week 14 or Early Discontinuation Visit) | The range for Myoclonus Patient Questionnaire is 0 (best) to 44 (worst). Percent change from Baseline = 100 X ((Baseline UMRS1 - Treatment UMRS1) / Baseline UMRS1). Baseline is defined as the last non-missing value prior to or on Randomization Visit. |
| Secondary | Global Evaluation Score (Investigator) at the End of Treatment Period | End of Treatment Period (Week 14 or Early Discontinuation Visit) | The Global Evaluation Scale Score (Investigator) ranges from 1 (Marked worsening) to 7 (Marked improvement). |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change From Baseline to the End of Treatment Period on the Action Myoclonus Score (Unified Myoclonus Rating Scale (UMRS) Section 4) | From Baseline to End of Treatment Period (Week 14 or Early Discontinuation Visit) | The number of subjects is equal to the number of subjects in the Intent-To-Treat (ITT) population having non-missing post-baseline results for the percent change from baseline on the functional disability score (UMRS section 5). In case a subject drops out, the result at Early Discontinuation Visit is used. | Percent change | MEDIAN |
| SECONDARY | Percent Change From Baseline to the End of Treatment Period on the Functional Disability Score (Unified Myoclonus Rating Scale (UMRS) Section 5) | Baseline to End of Treatment Period (Week 14 or Early Discontinuation Visit) | The number of subjects is equal to the number of subjects in the Intent-To-Treat (ITT) population having non-missing post-baseline results for the percent change from baseline on the functional disability score (UMRS section 5). In case a subject drops out, the result at Early Discontinuation Visit is used. | Percent change | MEDIAN |
| SECONDARY | Percent Change From Baseline to the End of Treatment Period on the Stimulus Sensitivity Score (Unified Myoclonus Rating Scale (UMRS) Section 3) | Baseline to End of Treatment Period (Week 14 or Early Discontinuation Visit) | The number of subjects is equal to the number of subjects in the Intent-To-Treat (ITT) population having non-missing post-baseline results for the percent change from baseline on the stimulus sensitivity score (UMRS section 3). In case a subject drops out, the result at Early Discontinuation Visit (EDV) is used. | Percent change | MEDIAN |
| SECONDARY | Percent Change From Baseline to the End of Treatment Period on the Myoclonus Patient Questionnaire (Unified Myoclonus Rating Scale (UMRS) Section 1) | Baseline to End of Treatment Period (Week 14 or Early Discontinuation Visit) | The number of subjects is equal to the number of subjects in the Intent-To-Treat (ITT) population having non-missing post-baseline results for the percent change from baseline on the Myoclonus Patient Questionnaire (UMRS section 1). In case a subject drops out, the result at Early Discontinuation Visit (EDV) is used. | Percent change | MEDIAN |
| SECONDARY | Global Evaluation Score (Investigator) at the End of Treatment Period | End of Treatment Period (Week 14 or Early Discontinuation Visit) | The number of subjects is equal to the number of subjects in the Intent-To-Treat (ITT) population having non-missing post-baseline results for the Global Evaluation Score (I-GES). In case a subject drops out, the result at Early Discontinuation Visit (EDV) is used. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group33
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change From Baseline to the End of Treatment Period on the Action Myoclonus Score (Unified Myoclonus Rating Scale (UMRS) Section 4) | Placebo | 17.45 | Full Range -170.0 to 61.5 | Percent change | |
| Percent Change From Baseline to the End of Treatment Period on the Action Myoclonus Score (Unified Myoclonus Rating Scale (UMRS) Section 4) | Brivaracetam 5 mg/Day | -4.60 | Full Range -430.0 to 81.8 | Percent change | |
| Percent Change From Baseline to the End of Treatment Period on the Action Myoclonus Score (Unified Myoclonus Rating Scale (UMRS) Section 4) | Brivaracetam 150 mg/Day | 12.34 | Full Range -58.3 to 96.9 | Percent change | |
| Percent Change From Baseline to the End of Treatment Period on the Functional Disability Score (Unified Myoclonus Rating Scale (UMRS) Section 5) | Placebo | 0.00 | Full Range -380.0 to 53.8 | Percent change | |
| Percent Change From Baseline to the End of Treatment Period on the Functional Disability Score (Unified Myoclonus Rating Scale (UMRS) Section 5) | Brivaracetam 5 mg/Day | 0.00 | Full Range -380.0 to 60.0 | Percent change | |
| Percent Change From Baseline to the End of Treatment Period on the Functional Disability Score (Unified Myoclonus Rating Scale (UMRS) Section 5) | Brivaracetam 150 mg/Day | 0.00 | Full Range -85.7 to 75.0 | Percent change | |
| Percent Change From Baseline to the End of Treatment Period on the Stimulus Sensitivity Score (Unified Myoclonus Rating Scale (UMRS) Section 3) | Placebo | 0.00 | Full Range -300.0 to 100.0 | Percent change | |
| Percent Change From Baseline to the End of Treatment Period on the Stimulus Sensitivity Score (Unified Myoclonus Rating Scale (UMRS) Section 3) | Brivaracetam 5 mg/Day | 43.44 | Full Range -300.0 to 100.0 | Percent change | |
| Percent Change From Baseline to the End of Treatment Period on the Stimulus Sensitivity Score (Unified Myoclonus Rating Scale (UMRS) Section 3) | Brivaracetam 150 mg/Day | 0.00 | Full Range -300.0 to 100.0 | Percent change | |
| Percent Change From Baseline to the End of Treatment Period on the Myoclonus Patient Questionnaire (Unified Myoclonus Rating Scale (UMRS) Section 1) | Placebo | -9.68 | Full Range -125.0 to 63.0 | Percent change |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 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 | 18 | |
| Overall Study | STARTED | Brivaracetam 5 mg/Day | 20 | |
| Overall Study | STARTED | Brivaracetam 150 mg/Day | 18 | |
| Overall Study | COMPLETED | Placebo | 17 | |
| Overall Study | COMPLETED | Brivaracetam 5 mg/Day | 20 | |
| Overall Study | COMPLETED | Brivaracetam 150 mg/Day | 17 | |
| Overall Study | NOT COMPLETED | Placebo | 1 | |
| Overall Study | NOT COMPLETED | Brivaracetam 5 mg/Day | 0 | |
| Overall Study | NOT COMPLETED | Brivaracetam 150 mg/Day | 1 |
Source ClinicalTrials.gov
Adverse events258
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 | Granulocytopenia | Blood and lymphatic system disorders | Placebo | 0 | 18 | 0 |
| other | Granulocytopenia | Blood and lymphatic system disorders | Brivaracetam 5 mg/Day | 0 | 20 | 0 |
| other | Granulocytopenia | Blood and lymphatic system disorders | Brivaracetam 150 mg/Day | 1 | 18 | 1 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Placebo | 0 | 18 | 0 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Brivaracetam 5 mg/Day | 0 | 20 | 0 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Brivaracetam 150 mg/Day | 1 | 18 | 1 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Placebo | 0 | 18 | 0 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Brivaracetam 5 mg/Day | 0 | 20 | 0 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Brivaracetam 150 mg/Day | 1 | 18 | 2 |
| other | Angina pectoris | Cardiac disorders | Placebo | 0 | 18 | 0 |
1 to 10 of 258Source ClinicalTrials.gov
See all 258 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 5 mg/Day | ||
| Total, all-cause mortality | Brivaracetam 150 mg/Day | ||
| Total, other adverse events | Placebo | 13 | 18 |
| Total, other adverse events | Brivaracetam 5 mg/Day | 13 | 20 |
| Total, other adverse events | Brivaracetam 150 mg/Day | 15 | 18 |
| Total, serious adverse events | Placebo | 2 | 18 |
| Total, serious adverse events | Brivaracetam 5 mg/Day | 3 | 20 |
| Total, serious adverse events | Brivaracetam 150 mg/Day | 2 | 18 |
Source ClinicalTrials.gov
Papers2
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
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