Trial · NCT02495844
A Study of UCB0942 in Adult Patients With Highly Drug-resistant Focal Epilepsy
NCT02495844, Phase 2, Completed, UCB Biopharma S.P.R.L.; results first posted 2019-02-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of UCB0942 in Adult Patients With Highly Drug-resistant Focal Epilepsy. Trials, record NCT02495844. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02495844
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of UCB0942 in Adult Patients With Highly Drug-resistant Focal Epilepsy
- NCT number
- NCT02495844
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 55 participants, actual
- Lead sponsor
- UCB Biopharma S.P.R.L.
- Conditions
- Highly Drug-resistant Focal Epilepsy
- Interventions
- UCB0942, UCB0942, Placebo
- First posted
- 2015-07-13
- Last updated
- 2019-02-05
- Other registries' IDs
- eudract:2014-003330-12
- Results first posted
- 2019-02-05
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 75 % Responder Rate During the 2-week Inpatient Period | During the 2-week Inpatient Period | The 75% responder rate is defined as the percentage of subjects with a 75 % or greater reduction in focal seizure frequency during the 2-week Inpatient Period compared with the Baseline Period. |
| Secondary | Median Percent Change in Weekly Focal Seizure Frequency During the 2-week Inpatient Period | During the 2-week Inpatient Period | A negative value in median percent change reflects a reduction from Baseline. |
| Secondary | Median Percent Change in Weekly Focal Seizure Frequency During the Outpatient Maintenance Period | During the Outpatient Maintenance Period (8 weeks) | A negative value in median percent change reflects a reduction from Baseline. |
| Secondary | Median Percent Change in Weekly Focal Seizure Frequency During the On-UCB0942 Overall Period | During the On-UCB0942 Overall Period (approximately 11 weeks) | A negative value in median percent change reflects a reduction from Baseline. |
| Secondary | Seizure-free Rate (All Seizures) During the 2-week Inpatient Period | During the 2-week Inpatient Period | Seizure-free rate is reported as the percentage of seizure-free participants during the 2-week Inpatient Period. |
| Secondary | Seizure-free Rate (All Seizures) During the Last 4 Weeks of the Outpatient Maintenance Period | During the last 4 weeks of the Outpatient Maintenance Period | Seizure-free rate is reported as the percentage of seizure-free participants during the last 4 weeks of the Outpatient Maintenance Period. |
| Secondary | Seizure-free Rate (All Seizures) During the On-UCB0942 Overall Period | During the On-UCB0942 Overall Period (approximately 11 weeks) | Seizure-free rate is reported as the percentage of seizure-free participants during the On-UCB0942 Overall Period. |
| Secondary | 75 % Responder Rate During the Last 4 Weeks of the Outpatient Maintenance Period | During the last 4 weeks of the Outpatient Maintenance Period | The 75 % responder rate is defined as the percentage of subjects who achieve a 75 % or greater reduction in focal seizure frequency. |
| Secondary | 75 % Responder Rate During the On-UCB0942 Overall Period | During the On-UCB0942 Overall Period (approximately 11 weeks) | The 75 % responder rate is defined as the percentage of subjects who achieve a 75 % or greater reduction in focal seizure frequency. |
| Secondary | Percentage of Seizure Free Days (All Seizures) During the 2-week Inpatient Period | During the 2-week Inpatient Period | For the active group, the 2-week Inpatient Period refers to the last 2 weeks of the Inpatient Period, while for the Placebo group, it refers to the first 2 weeks of the Inpatient Period. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 75 % Responder Rate During the 2-week Inpatient Period | During the 2-week Inpatient Period | percentage of participants | NUMBER | |
| SECONDARY | Median Percent Change in Weekly Focal Seizure Frequency During the 2-week Inpatient Period | During the 2-week Inpatient Period | percentage of change | MEDIAN | |
| SECONDARY | Median Percent Change in Weekly Focal Seizure Frequency During the Outpatient Maintenance Period | During the Outpatient Maintenance Period (8 weeks) | percentage of change | MEDIAN | |
| SECONDARY | Median Percent Change in Weekly Focal Seizure Frequency During the On-UCB0942 Overall Period | During the On-UCB0942 Overall Period (approximately 11 weeks) | percentage of change | MEDIAN | |
| SECONDARY | Seizure-free Rate (All Seizures) During the 2-week Inpatient Period | During the 2-week Inpatient Period | percentage of particpants | NUMBER | |
| SECONDARY | Seizure-free Rate (All Seizures) During the Last 4 Weeks of the Outpatient Maintenance Period | During the last 4 weeks of the Outpatient Maintenance Period | percentage of participants | NUMBER | |
| SECONDARY | Seizure-free Rate (All Seizures) During the On-UCB0942 Overall Period | During the On-UCB0942 Overall Period (approximately 11 weeks) | percentage of participants | NUMBER | |
| SECONDARY | 75 % Responder Rate During the Last 4 Weeks of the Outpatient Maintenance Period | During the last 4 weeks of the Outpatient Maintenance Period | percentage of participants | NUMBER | |
| SECONDARY | 75 % Responder Rate During the On-UCB0942 Overall Period | During the On-UCB0942 Overall Period (approximately 11 weeks) | percentage of participants | NUMBER | |
| SECONDARY | Percentage of Seizure Free Days (All Seizures) During the 2-week Inpatient Period | During the 2-week Inpatient Period | percentage of days | MEDIAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 75 % Responder Rate During the 2-week Inpatient Period | Placebo/UCB0942 (FAS) | 11.1 | percentage of participants | ||
| 75 % Responder Rate During the 2-week Inpatient Period | UCB0942/UCB0942 (FAS) | 30.8 | percentage of participants | ||
| Median Percent Change in Weekly Focal Seizure Frequency During the 2-week Inpatient Period | Placebo/UCB0942 (FAS) | -12.5 | Inter-Quartile Range -57.14 to 41.11 | percentage of change | |
| Median Percent Change in Weekly Focal Seizure Frequency During the 2-week Inpatient Period | UCB0942/UCB0942 (FAS) | -53.68 | Inter-Quartile Range -84.61 to -22.73 | percentage of change | |
| Median Percent Change in Weekly Focal Seizure Frequency During the Outpatient Maintenance Period | Placebo/UCB0942 (FAS) | -57.94 | Inter-Quartile Range -76.23 to -29.09 | percentage of change | |
| Median Percent Change in Weekly Focal Seizure Frequency During the Outpatient Maintenance Period | UCB0942/UCB0942 (FAS) | -26.32 | Inter-Quartile Range -77.38 to -3.07 | percentage of change | |
| Median Percent Change in Weekly Focal Seizure Frequency During the On-UCB0942 Overall Period | Placebo/UCB0942 (FAS) | -53.85 | Inter-Quartile Range -78.01 to -34.48 | percentage of change | |
| Median Percent Change in Weekly Focal Seizure Frequency During the On-UCB0942 Overall Period | UCB0942/UCB0942 (FAS) | -29.87 | Inter-Quartile Range -76.39 to -11.36 | percentage of change | |
| Seizure-free Rate (All Seizures) During the 2-week Inpatient Period | Placebo/UCB0942 (FAS) | 3.7 | percentage of particpants | ||
| Seizure-free Rate (All Seizures) During the 2-week Inpatient Period | UCB0942/UCB0942 (FAS) | 7.4 | percentage of particpants |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 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/UCB0942 | 27 | |
| Overall Study | STARTED | UCB0942/UCB0942 | 28 | |
| Overall Study | COMPLETED | Placebo/UCB0942 | 26 | |
| Overall Study | COMPLETED | UCB0942/UCB0942 | 24 | |
| Overall Study | NOT COMPLETED | Placebo/UCB0942 | 1 | |
| Overall Study | NOT COMPLETED | UCB0942/UCB0942 | 4 |
Source ClinicalTrials.gov
Adverse events92
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 | Somnolence | Nervous system disorders | Placebo/UCB0942 | 12 | 27 | 16 |
| other | Somnolence | Nervous system disorders | UCB0942/UCB0942 | 17 | 28 | 24 |
| other | Dizziness | Nervous system disorders | Placebo/UCB0942 | 12 | 27 | 51 |
| other | Dizziness | Nervous system disorders | UCB0942/UCB0942 | 14 | 28 | 19 |
| other | Headache | Nervous system disorders | Placebo/UCB0942 | 6 | 27 | 9 |
| other | Headache | Nervous system disorders | UCB0942/UCB0942 | 10 | 28 | 13 |
| other | Tremor | Nervous system disorders | Placebo/UCB0942 | 3 | 27 | 3 |
| other | Tremor | Nervous system disorders | UCB0942/UCB0942 | 2 | 28 | 2 |
| other | Disturbance in attention | Nervous system disorders | Placebo/UCB0942 | 1 | 27 | 2 |
| other | Disturbance in attention | Nervous system disorders | UCB0942/UCB0942 | 3 | 28 | 3 |
1 to 10 of 92Source ClinicalTrials.gov
See all 92 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo/UCB0942 | 0 | 27 |
| Total, all-cause mortality | UCB0942/UCB0942 | 0 | 28 |
| Total, other adverse events | Placebo/UCB0942 | 26 | 27 |
| Total, other adverse events | UCB0942/UCB0942 | 27 | 28 |
| Total, serious adverse events | Placebo/UCB0942 | 0 | 27 |
| Total, serious adverse events | UCB0942/UCB0942 | 2 | 28 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| UCB0942/UCB0942 (SS) vs Placebo/UCB0942 (SS): Number of Subject Withdrawals Due to Adverse Events (AEs) During the Course of the Study | Trial comparisons |
| UCB0942/UCB0942 (SS) vs Placebo/UCB0942 (SS): Number of Patients Reporting at Least One Serious Adverse Event (SAE) During the Course of the Study | Trial comparisons |
| UCB0942/UCB0942 vs Placebo/UCB0942: deaths from any cause | Trial comparisons |
| UCB0942/UCB0942 vs Placebo/UCB0942: serious adverse events | 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/NCT02495844
GET https://conductscience.org/api/trials/v1/NCT02495844/results?page=2