JNJ-40411813 for Seizures
Phase-Based Progress Estimates
Effectiveness
Safety
Seizures+1 More
JNJ-40411813 - DrugEligibility
18+
All Sexes
What conditions do you have?
Select
Eligibility
18+
All Sexes
What conditions do you have?
Select
Study Summary
This trial is testing a new drug to see if it can help people with epilepsy who are already taking other medication. The trial will last for a while, and participants will be monitored for safety and efficacy.
Eligible Conditions
- Seizures
Treatment Effectiveness
Effectiveness Progress
Study Objectives
5 Primary · 21 Secondary · Reporting Duration: Up to 2 years in OLE period
Week 4
Double Blind Treatment Period: Plasma Concentration of JNJ-40411813
Double Blind Treatment Period: Plasma Concentration of Levetiracetam
Plasma Exchange
Plasma concentrations of JNJ-40411813
Plasma concentrations of Levetiracetam
Baseline to 12 weeks
Time to Baseline Monthly Seizure Count up to the end of the 12-week Double-blind Treatment Period
Week 12
Double Blind Treatment Period: Percent reduction in the Double-blind Monthly Seizure Count
Double Blind Treatment Period: Percentage of Participants with no Seizures During Double-blind Period and who Achieve a More than (>) 50 Percent (%) Reduction in Monthly Seizure Count Relative to Baseline Monthly Seizure Count
Blindness
Percentage of Participants with no Seizures During Double-blind Period and who Achieve a More than (>) 50 Percent (%) Reduction in Monthly Seizure Count Relative to Baseline Monthly Seizure Count
Year 1
OLE Period: Plasma Concentration of Anti-epileptic Drugs (AEDs)
OLE Period: Plasma Concentration of JNJ-40411813
OLE Period: Plasma Concentration of Levetiracetam
Plasma Exchange
Up to 12 weeks
Double Blind Treatment Period: Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Results
Double Blind Treatment Period: Number of Participants with Clinically Significant Changes in Laboratory Results
Double Blind Treatment Period: Number of Participants with Clinically Significant Changes in Vital Signs
Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Results
Number of Participants with Clinically Significant Changes in Laboratory Results
Number of Participants with Clinically Significant Changes in Vital Signs
Year 2
OLE Period: Number of Participants with Adverse Events (AEs)
OLE Period: Number of Participants with Clinically Significant Changes in Laboratory Assessments
OLE Period: Number of Participants with Clinically Significant Changes in Vital Signs
Open Label Extension (OLE) Period: Seizure Count
Up to 22 weeks
Double Blind Treatment Period: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
2 Treatment Groups
JNJ-40411813
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group
160 Total Participants · 2 Treatment Groups
Primary Treatment: JNJ-40411813 · Has Placebo Group · Phase 2
JNJ-40411813
Drug
Experimental Group · 1 Intervention: JNJ-40411813 · Intervention Types: DrugPlaceboPlaceboComparator Group · 2 Interventions: JNJ-40411813, Placebo · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
JNJ-40411813
Not yet FDA approved
Trial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years in ole period
Who is running the clinical trial?
Janssen Research & Development, LLCLead Sponsor
918 Previous Clinical Trials
6,327,006 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
707 Previous Clinical Trials
3,899,984 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 6 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You have had a neuroimaging procedure within 10 years, including a computed tomography (CT) scan or magnetic resonance imaging (MRI), that excluded a progressive neurologic disorder; these procedures may be performed within the 8-week baseline period.
Cohort 1: Current treatment with at least 1 and up to 4 AEDs (including levetiracetam or brivaracetam), administered at stable dosage(s) for at least 1 month before screening, and no new AEDs added for the previous 2 months; these AEDs must remain unchanged throughout the pretreatment and double-blind treatment periods (with the exception of dosage reductions of concomitant AEDs because of suspected elevated AED levels or side effects)
You are currently showing inadequate response to levetiracetam, administered at the appropriate dosage(s) and for a sufficient treatment period, based on the judgment of the investigator.
You are between 18 and 69 years old.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
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