Trial · NCT04836559
A Study to Investigate JNJ-40411813 in Combination With Levetiracetam or Brivaracetam in Epilepsy
NCT04836559, Phase 2, Completed, Janssen Research & Development, LLC; results first posted 2025-07-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Investigate JNJ-40411813 in Combination With Levetiracetam or Brivaracetam in Epilepsy. Trials, record NCT04836559. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04836559
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Investigate JNJ-40411813 in Combination With Levetiracetam or Brivaracetam in Epilepsy
- NCT number
- NCT04836559
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 110 participants, actual
- Lead sponsor
- Janssen Research & Development, LLC
- Conditions
- Focal Onset Seizures
- Interventions
- JNJ-40411813, Placebo
- First posted
- 2021-04-08
- Last updated
- 2025-07-03
- Other registries' IDs
- eudract:2020-003698-24
- Results first posted
- 2025-07-03
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cohort 1 and 2: Time to Baseline Monthly Seizure Count up to the End of the 12-week Double-blind (DB) Treatment Period | From DB period Day 1 up to Day 85 | Time (in days) to baseline monthly seizure count was defined as the number of days until the participants cumulative seizure count during the DB period was equal to their baseline monthly seizure count. The baseline monthly seizure count was defined as the number of observable focal onset seizures occurred during the 8-week baseline period (Day -56 to -1), multiplied by 28/XBL, where XBL was the number of days comprising the participants baseline period. Observable focal onset seizures included focal aware seizures with motor signs, focal impaired awareness seizures and focal to bilateral tonic-clonic seizures. Focal aware seizures without motor signs, myoclonic, or other generalized seizures was not counted towards baseline monthly seizure count. Cluster seizures were counted as a single seizure. Kaplan-Meier method was used for the analysis. |
| Secondary | Cohort 1 and 2: Percent Reduction in the Open Label Extension (OLE) Period Monthly Seizure Rate | From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) | The percent reduction in the OLE monthly seizure rate was defined as 100\*(baseline monthly seizure count minus OLE monthly seizure count) divided by (baseline monthly seizure count). The OLE monthly seizure count was defined as the total number of observable focal onset seizures occurred during the OLE period, multiplied by 28/XOLE, where XOLE was the number of days comprising the OLE. A positive percentage change in the OLE monthly seizure count indicated improvement. Observable seizures included focal aware seizures with motor signs, focal impaired awareness seizures and focal to bilateral tonic-clonic seizures. Focal aware seizures without motor signs, myoclonic, or other generalized seizures was not counted towards baseline monthly seizure count. Cluster seizures were counted as a single seizure. |
| Secondary | Cohort 1 and 2: Number of Participants With Seizure Freedom at the End of OLE Period | From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) | Number of participants with seizure freedom at the end of OLE period was reported. Seizure freedom was defined as having no seizures over the complete OLE study period. |
| Secondary | Cohort 1 and 2: Number of Participants With at Least 50 Percent (%) Reduction (Response) in the OLE Monthly Seizure Count | From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) | Number of participants having at least a 50% reduction in the monthly seizure rate (response) during the OLE study period was reported. |
| Secondary | OLE Period: Cohort 1 and 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | From OLE baseline (Day 1 of OLE) up to 5 days after last dose of OLE period (5 days + 24 months after start of OLE) (the actual OLE starting time varied for each participant) | Number of participants with TEAEs and TESAEs were reported. An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. A serious AE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product, or was medically important. TEAE/TESAE was defined as any AE/SAE occurred at or after the initial administration of study intervention through the day of last dose plus 5 days. TEAEs included serious and non-serious events. |
| Secondary | OLE Period: Cohort 1 and 2: Number of Participants With Treatment-emergent (TE) Clinically Important Changes in Vital Signs | From OLE baseline (Day 1 of OLE) up to 24 months + 5 days after start of OLE (the actual OLE starting time varied for each participant) | TE clinically important changes in vital signs (VS) were pulse rate (PR) greater than (\>)100 beats per min \[bpm\] and with \>30bpm increase from baseline (BL), PR less than (\<)50 bpm and with \>20bpm decrease from BL, systolic blood pressure (SBP) \>140 millimeters of mercury (mmHg) and with \>40mm Hg increase from BL, SBP \<90mmHg and with \>30mmHg decrease from BL), diastolic blood pressure (DBP) \>90mmHg and with \>30mmHg increase from BL, DBP \<50mmHg and with \>20 mmHg decrease from BL, and temperature \>38 degree Celsius(C) and with greater than or equal to (\>=)1degree C increase from BL. TE: post BL value was above upper limit and BL value was below upper limit (example: Normal or Low). Same applied to post BL value being below lower limit with BL value being above lower limit (example: Normal or High). TEVS: VS which occurred as at or after initial administration of study intervention through last dose plus 5 days. Only categories in which at least 1 participant had data were reported. |
| Secondary | OLE Period: Cohort 1 and 2: Number of Participants With Changes in Laboratory Assessments Recorded as TEAE | From OLE baseline (Day 1 of OLE) up to 24 months + 5 days after start of OLE (the actual OLE starting time varied for each subject) | Number of participants with changes in laboratory assessments recorded as TEAE were reported. Laboratory assessments included clinical chemistry, hematology and urinalysis. Postbaseline abnormalities were compared with baseline values: if postbaseline value exceeding the upper limit (with baseline below upper limit) or falling below the lower limit (with baseline above lower limit) was considered treatment-emergent (TE); if baseline values were missing then any postbaseline abnormality was considered TE. TEAE was defined as any AE occurring at or after the initial administration of study intervention through the day of last dose plus 5 days. |
| Secondary | DB Treatment Period: Cohort 1 and 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90) | Number of participants with TEAEs and TESAEs were reported. An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. A serious AE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product, or was medically important. TEAE/TESAE was defined as any AE/SAE occurred at or after the initial administration of study intervention through the day of last dose plus 5 days. TEAEs included serious and non-serious events. |
| Secondary | DB Treatment Period: Cohort 1 and 2: Number of Participants With Treatment-emergent Clinically Important Changes in Vital Signs | From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90) | Treatment-emergent clinically important changes in vital signs defined as PR \>100 bpm and with \>30 bpm increase from baseline, PR \<50 bpm and with \>20 bpm decrease from baseline, SBP \>140 mm Hg and with \>40 mm Hg increase from baseline, SBP \<90 mm Hg and with \>30 mm Hg decrease from baseline, DBP \>90 mm Hg and with \>30 mm Hg increase from baseline, DBP \<50 mm Hg and with \>20 mm Hg decrease from baseline, temperature \>38 degree C and with \>=1 degree C increase from baseline. TE clinically important changes: if postbaseline value was above upper limit and baseline value was below upper limit (example: Normal or Low). Same applied to postbaseline value being below lower limit with baseline value being above lower limit (example: Normal or High). Only those categories in which at least 1 participant had data were reported in this outcome measure. TE vital signs included vital signs which occurred as at or after initial administration of study intervention through last dose plus 5 days. |
| Secondary | DB Treatment Period: Cohort 1 and 2: Number of Participants With Treatment-emergent Clinically Important Changes in Electrocardiogram (ECG) | From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90) | The ECG parameters analyzed: heart rate, PR interval, RR interval, QRS interval, QT interval, and corrected QT (QTc) interval using the correction methods: Bazett's formula (QTcB), Fridericia's formula (QTcF). TE clinically important changes ECG values (relative to baseline) were defined as heart rate (bpm): \<45 and \>100; PR interval (millisecond \[msec\]): \<120 and \>200; QRS interval (msec): \>120; QTc (msec): \>470 in women and \>450 in men. TE was concluded if the postbaseline value was above the upper limit and the baseline value was below the upper limit (example: Normal or Low). The same applied to the postbaseline value being below the lower limit with the baseline value being above the lower limit (example: Normal or High). TE ECGs: clinically important ECGs which occurred as at or after initial administration of study intervention through last dose plus 5 days. Only categories in which at least 1 participant had data were reported in this outcome measure. |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Cohort 1 and 2: Time to Baseline Monthly Seizure Count up to the End of the 12-week Double-blind (DB) Treatment Period | From DB period Day 1 up to Day 85 | Full analysis set (FAS) included all randomized participants assigned to receive study intervention and had both baseline and postbaseline seizure data. | Days | MEDIAN |
| SECONDARY | Cohort 1 and 2: Percent Reduction in the Open Label Extension (OLE) Period Monthly Seizure Rate | From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) | Full analysis set: open-label extension (FASOLE) analysis set included all FAS participants who received at least 1 dose of study intervention in the OLE period. | Percent change (reduction) | MEDIAN |
| SECONDARY | Cohort 1 and 2: Number of Participants With Seizure Freedom at the End of OLE Period | From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) | FASOLE analysis set included all FAS participants who received at least 1 dose of study intervention in the OLE period. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Cohort 1 and 2: Number of Participants With at Least 50 Percent (%) Reduction (Response) in the OLE Monthly Seizure Count | From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) | FASOLE analysis set included all FAS participants who received at least 1 dose of study intervention in the OLE period. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | OLE Period: Cohort 1 and 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | From OLE baseline (Day 1 of OLE) up to 5 days after last dose of OLE period (5 days + 24 months after start of OLE) (the actual OLE starting time varied for each participant) | Safety open label extension (SAFOLE) analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | OLE Period: Cohort 1 and 2: Number of Participants With Treatment-emergent (TE) Clinically Important Changes in Vital Signs | From OLE baseline (Day 1 of OLE) up to 24 months + 5 days after start of OLE (the actual OLE starting time varied for each participant) | SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period. Here 'N' (overall number of participants analyzed) refers to the number of participants with at least 1 postbaseline value for the specified vital sign parameter and 'n' (number analyzed) refers to number of participants evaluable at specified parameter. n=0 indicates that there was no evaluable participant for specified parameter. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | OLE Period: Cohort 1 and 2: Number of Participants With Changes in Laboratory Assessments Recorded as TEAE | From OLE baseline (Day 1 of OLE) up to 24 months + 5 days after start of OLE (the actual OLE starting time varied for each subject) | SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | DB Treatment Period: Cohort 1 and 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90) | Safety analysis set (SAF) included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the double-blind period. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | DB Treatment Period: Cohort 1 and 2: Number of Participants With Treatment-emergent Clinically Important Changes in Vital Signs | From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90) | Safety analysis set included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the double-blind period. Here 'N' (overall number of participants analyzed) refers to the number of participants with at least 1 postbaseline value for the specified vital sign parameter and 'n' (number analyzed) refers to number of participants evaluable at specified parameter. n=0 indicates that there was no evaluable participant for specified parameter. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | DB Treatment Period: Cohort 1 and 2: Number of Participants With Treatment-emergent Clinically Important Changes in Electrocardiogram (ECG) | From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90) | Safety analysis set included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the double-blind period. Here 'n' (number analyzed) refers to number of participants with at least 1 postbaseline value for the specified parameter. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group374
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Cohort 1 and 2: Time to Baseline Monthly Seizure Count up to the End of the 12-week Double-blind (DB) Treatment Period | DB: Cohort 1: Placebo | 32 | 95% Confidence Interval 28 to 37 | Days | |
| Cohort 1 and 2: Time to Baseline Monthly Seizure Count up to the End of the 12-week Double-blind (DB) Treatment Period | DB: Cohort 1: JNJ-40411813 | 34 | 95% Confidence Interval 27 to 48 | Days | |
| Cohort 1 and 2: Time to Baseline Monthly Seizure Count up to the End of the 12-week Double-blind (DB) Treatment Period | DB: Cohort 2: Placebo | 29 | 95% Confidence Interval 22 to 69 | Days | |
| Cohort 1 and 2: Time to Baseline Monthly Seizure Count up to the End of the 12-week Double-blind (DB) Treatment Period | DB: Cohort 2: JNJ-40411813 | 38 | 95% Confidence Interval 28 to 48 | Days | |
| Cohort 1 and 2: Percent Reduction in the Open Label Extension (OLE) Period Monthly Seizure Rate | OLE: Cohort 1: Placebo Followed by JNJ-40411813 | 39.9 | Inter-Quartile Range 14.3 to 64.1 | Percent change (reduction) | |
| Cohort 1 and 2: Percent Reduction in the Open Label Extension (OLE) Period Monthly Seizure Rate | OLE: Cohort 1: JNJ-40411813 Followed by JNJ-40411813 | 49.1 | Inter-Quartile Range -1.5 to 77.1 | Percent change (reduction) | |
| Cohort 1 and 2: Percent Reduction in the Open Label Extension (OLE) Period Monthly Seizure Rate | OLE: Cohort 2: Placebo Followed by JNJ-40411813 | 29.1 | Inter-Quartile Range 22.6 to 76.6 | Percent change (reduction) | |
| Cohort 1 and 2: Percent Reduction in the Open Label Extension (OLE) Period Monthly Seizure Rate | OLE: Cohort 2: JNJ-40411813 Followed by JNJ-40411813 | 52.1 | Inter-Quartile Range -3.7 to 85.0 | Percent change (reduction) | |
| Cohort 1 and 2: Number of Participants With Seizure Freedom at the End of OLE Period | OLE: Cohort 1: Placebo Followed by JNJ-40411813 | 1 | 14.3 to 64.1 | Participants | |
| Cohort 1 and 2: Number of Participants With Seizure Freedom at the End of OLE Period | OLE: Cohort 1: JNJ-40411813 Followed by JNJ-40411813 | 0 | -1.5 to 77.1 | Participants |
1 to 10 of 374Source ClinicalTrials.gov
See all 374 results by groupParticipant flow88
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double Blind Period (Day 1 to Day 85) | STARTED | DB: Cohort 1: Placebo | 20 | |
| Double Blind Period (Day 1 to Day 85) | STARTED | DB: Cohort 1: JNJ-40411813 | 40 | |
| Double Blind Period (Day 1 to Day 85) | STARTED | DB: Cohort 2: Placebo | 9 | |
| Double Blind Period (Day 1 to Day 85) | STARTED | DB: Cohort 2: JNJ-40411813 | 41 | |
| Double Blind Period (Day 1 to Day 85) | STARTED | OLE: Cohort 1: Placebo Followed by JNJ-40411813 | 0 | |
| Double Blind Period (Day 1 to Day 85) | STARTED | OLE: Cohort 1: JNJ-40411813 Followed by JNJ-40411813 | 0 | |
| Double Blind Period (Day 1 to Day 85) | STARTED | OLE: Cohort 2: Placebo Followed by JNJ-40411813 | 0 | |
| Double Blind Period (Day 1 to Day 85) | STARTED | OLE: Cohort 2: JNJ-40411813 Followed by JNJ-40411813 | 0 | |
| Double Blind Period (Day 1 to Day 85) | Full Analysis Set | DB: Cohort 1: Placebo | 20 | |
| Double Blind Period (Day 1 to Day 85) | Full Analysis Set | DB: Cohort 1: JNJ-40411813 | 40 |
1 to 10 of 88Source ClinicalTrials.gov
See all 88 participant flowAdverse events424
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 | Vertigo | Ear and labyrinth disorders | DB: Cohort 1: Placebo | 0 | 20 | |
| other | Vertigo | Ear and labyrinth disorders | DB: Cohort 1: JNJ-40411813 | 0 | 40 | |
| other | Vertigo | Ear and labyrinth disorders | DB: Cohort 2: Placebo | 1 | 9 | |
| other | Vertigo | Ear and labyrinth disorders | DB: Cohort 2: JNJ-40411813 | 5 | 41 | |
| other | Vertigo | Ear and labyrinth disorders | OLE: Cohort 1: Placebo Followed by JNJ-40411813 | 0 | 12 | |
| other | Vertigo | Ear and labyrinth disorders | OLE: Cohort 1: JNJ-40411813 Followed by JNJ-40411813 | 1 | 23 | |
| other | Vertigo | Ear and labyrinth disorders | OLE: Cohort 2: Placebo Followed by JNJ-40411813 | 1 | 7 | |
| other | Vertigo | Ear and labyrinth disorders | OLE: Cohort 2: JNJ-40411813 Followed by JNJ-40411813 | 0 | 31 | |
| other | Diplopia | Eye disorders | DB: Cohort 1: Placebo | 0 | 20 | |
| other | Diplopia | Eye disorders | DB: Cohort 1: JNJ-40411813 | 1 | 40 |
1 to 10 of 424Source ClinicalTrials.gov
See all 424 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | DB: Cohort 1: Placebo | 0 | 20 |
| Total, all-cause mortality | DB: Cohort 1: JNJ-40411813 | 0 | 40 |
| Total, all-cause mortality | DB: Cohort 2: Placebo | 0 | 9 |
| Total, all-cause mortality | DB: Cohort 2: JNJ-40411813 | 0 | 41 |
| Total, all-cause mortality | OLE: Cohort 1: Placebo Followed by JNJ-40411813 | 0 | 12 |
| Total, all-cause mortality | OLE: Cohort 1: JNJ-40411813 Followed by JNJ-40411813 | 0 | 23 |
| Total, all-cause mortality | OLE: Cohort 2: Placebo Followed by JNJ-40411813 | 0 | 7 |
| Total, all-cause mortality | OLE: Cohort 2: JNJ-40411813 Followed by JNJ-40411813 | 0 | 31 |
| Total, other adverse events | DB: Cohort 1: Placebo | 7 | 20 |
| Total, other adverse events | DB: Cohort 1: JNJ-40411813 | 16 | 40 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers0
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 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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