Trial · NCT04836559
Outcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| 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 |
| SECONDARY | DB Treatment Period: Cohort 1 and 2: Number of Participants With Changes in Laboratory Assessments Recorded as TEAE | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Cohort 1 and 2: Percent Reduction in the Double-blind Period Monthly Seizure Rate | From DB period Day 1 up to Day 85 | FAS included all randomized participants assigned to receive study intervention and had both baseline and postbaseline seizure data. | Percent change (reduction) | MEDIAN |
| SECONDARY | Cohort 1 and 2: Percentage of Participants With Seizure Freedom During Double-blind Period | From DB period Day 1 up to Day 85 | FAS included all randomized participants assigned to receive study intervention and had both baseline and postbaseline seizure data. | Percentage of participants | NUMBER |
| SECONDARY | Cohort 1 and 2: Percentage of Participants Who Achieved a More Than (>) 50 Percent (%) Reduction (Response) in Double-blind Monthly Seizure Count Relative to Baseline Monthly Seizure Count | From DB period Day 1 up to Day 85 | FAS included all randomized participants assigned to receive study intervention and had both baseline and postbaseline seizure data. | Percentage of participants | NUMBER |
| SECONDARY | DB Treatment Period: Cohort 1 and 2: Plasma Concentration of JNJ-40411813 and Its Metabolites: M30, M45 and M47 | Day 1: 2 hours post-dose, Days 29: pre-dose and 1 hour post-dose, Day 57: pre-dose and Day 85: post-dose/Early withdrawal (EW) | Pharmacokinetic (PK) set: all randomized participants who received at least 1 dose of JNJ-40411813 and had at least 1 valid blood sample drawn for PK analysis and excluded samples with below lower limit of quantification or samples with inconsistent date/time or samples with previous dose date/time incomplete or samples with concentration less than (\<) 10 nanograms per milliliter (ng/mL). | Nanograms per milliliter | MEAN |
| SECONDARY | DB Treatment Period: Cohort 1 and 2: Plasma Concentration of AED: Levetiracetam | Day 1: pre-dose and 2 hours post-dose, Day 29: pre-dose and 1 hour post-dose, Day 57: pre-dose and Day 85: post-dose/Early withdrawal | PK set was used. Here, 'N' (overall number of participants analyzed)=number of participants evaluable for this OM; 'n' (number analyzed) = number of participants evaluable at each specified category. | Nanograms per milliliter | MEAN |
| SECONDARY | DB Treatment Period: Cohort 1 and 2: Plasma Concentration of AED: Brivaracetam | Day 1: pre-dose and 2 hours post-dose, Days 29: pre-dose and 1 hour post-dose, Day 57: pre-dose and Day 85: post-dose/Early withdrawal | PK set was used for the analysis. Here, 'N' (overall number of participants analyzed)=number of participants evaluable for this OM; 'n' (number analyzed) = number of participants evaluable at each specified category. Here, N=0 signifies that no participant received brivaracetam; n=0 in arm 'DB: Cohort 2: Placebo Non-induced' at timepoint 'Day 57: pre-dose' signifies that no participant was available at specific visit and thus, no data was collected and analyzed. | Nanograms per milliliter | MEAN |
| SECONDARY | DB Treatment Period: Cohort 1 and 2: Plasma Concentration of AED: Carbamazepine | Pre-dose: Day 1, Days 29, and Day 57 | PK set was used for the analysis. Here, 'N' (overall number of participants analyzed)=number of participants evaluable for this OM; 'n' (number analyzed) = number of participants evaluable at each specified category. Here, N=0 signifies that non-induced arms were not applicable to this outcome measure as carbamazepine itself is a CYP3A4-inducing AED. | Nanograms per milliliter | MEAN |
| SECONDARY | OLE Period: Cohort 1 and 2: Plasma Concentration of JNJ-40411813 and Its Metabolites: M30, M45 and M47 | Cohort 1:OLE visit 2 (1 month post OLE baseline[BL]), OLE visit 3 (2 months post OLE BL), OLE visit 4 to 7 (up to 1year post OLE BL);Cohort 2:OLE visit 2 (1 month post OLE BL), OLE visit 3 (2 months post OLE BL), OLE visit 4 to 5 (up to 1year post OLE BL) | PK set was used for the analysis. Here, n=0 signifies that none of the participants were evaluable for assessment in the specified arm for specified time point. Here, 'n' (number analyzed)=number of participants evaluable at each specified category. | Nanograms per milliliter | MEAN |
| SECONDARY | OLE Period: Cohort 1 and 2: Plasma Concentration of AED: Levetiracetam | OLE visit 2: 1st month; OLE visit 3: 2nd month | PK set was used. Here, 'N' (overall number of participants analyzed)=number of participants evaluable for this OM; 'n' (number analyzed) = number of participants evaluable at each specified category. | Nanograms per milliliter | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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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