What side effects are associated with this type of intervention?

Common treatments for partial seizures include levetiracetam, brivaracetam, felbamate, and topiramate. Levetiracetam and brivaracetam can cause side effects such as somnolence, dizziness, fatigue, and irritability. Felbamate, while effective, has serious potential side effects including aplastic anemia and liver failure, making it less commonly used. Topiramate is associated with side effects like paresthesia, fatigue, anorexia, weight loss, memory difficulties, and concentration problems. These side effects should be discussed with a healthcare provider to determine the best treatment plan.

What prior FDA approvals exist?

Several anti-epileptic drugs (AEDs) have been approved by the FDA for the treatment of partial seizures. Levetiracetam and brivaracetam, which are being used in combination with JNJ-40411813 in the study, are both FDA-approved for partial seizures. Other AEDs such as lamotrigine, carbamazepine, oxcarbazepine, and zonisamide have also been approved for this indication. These drugs have been evaluated in various clinical trials for their efficacy and safety in managing partial seizures.

What other types of research exist?

Promising novel alternatives to JNJ-40411813 for partial seizures include: 1) Perampanel, which has shown long-term efficacy and safety in Japanese patients with refractory partial-onset seizures. 2) USL255 (Qudexy XR), an extended-release topiramate, which demonstrated efficacy and safety in a global phase III study for refractory partial-onset seizures. 3) Cannabidiol (CBD), which has been studied in various forms and shown efficacy in treatment-resistant epilepsy, including partial seizures.

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JNJ-40411813 + Standard Epilepsy Meds for Epilepsy

Phase 2

Waitlist Available

Research Sponsored by Janssen Research & Development, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Cohort 1: Current treatment with at least 1 and up to 4 anti-epileptic drugs (AEDs) (including levetiracetam), 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) Cohort 2 and beyond: Current treatment with at least 1 and up to 4 AEDs (including levetiracetam or brivaracetam), administered at the appropriate dosage(s) and for a sufficient treatment period before screening. 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). Important note: screening of participants receiving brivaracetam will start when enrolling for Cohort 2

Minimum body weight should be 40 kg

Must not have

Have a generalized epileptic syndrome

Diagnosis of Lennox-Gastaut Syndrome

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years in ole period

Summary

This trial is testing JNJ-40411813, a new drug for people with focal onset seizures not fully controlled by other medications. The drug aims to reduce excessive brain activity by lowering glutamate levels. Participants will take this drug along with their current epilepsy medications.

Who is the study for?

Adults aged 18-69 with focal epilepsy, not well-controlled on current medications including levetiracetam or brivaracetam, can join this trial. They should have a BMI of 18-35 kg/m^2 and weigh at least 40 kg. Participants must have had stable seizure frequency (3 to 100 monthly) for the past six months and be able to maintain a seizure e-diary.

What is being tested?

The study is testing JNJ-40411813 as an additional treatment alongside standard anti-epileptic drugs like levetiracetam or brivaracetam. It will compare different doses of JNJ-40411813 against a placebo to see if it helps reduce the number of seizures over time.

What are the potential side effects?

While specific side effects are not listed here, participants may experience adverse reactions related to JNJ-40411813 or their existing anti-seizure medications. These could include typical drug-related side effects such as nausea, dizziness, fatigue, or more serious complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am currently taking 1-4 epilepsy drugs, including levetiracetam, without changes for the last month.

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My weight is at least 40 kg.

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I have been diagnosed with focal epilepsy for at least a year.

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I've had between 3 and 100 seizures each month for the last 6 months.

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I've had a brain scan in the last 10 years that ruled out progressive neurological disorders.

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I am currently taking 1 to 4 seizure medications, including either levetiracetam or brivaracetam.

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I am between 18 and 69 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with a generalized epilepsy syndrome.

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I have been diagnosed with Lennox-Gastaut Syndrome.

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I have had seizures that are not caused by epilepsy.

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I am not allergic to the trial medication or its ingredients.

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I am currently taking vigabatrin.

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I have not had a major psychotic disorder or severe depression with psychosis in the past year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years in ole period

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years in ole period

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years in ole period for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

+2 more

Secondary study objectives

Double Blind Treatment Period: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability

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

+8 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: JNJ-40411813Experimental Treatment1 Intervention

Participants will receive JNJ-40411813 twice a day (bid) up to 12 weeks in double blind period. Up to 3 different doses (low, medium, high) of JNJ-40411813 will be administered in this study. Participants will also receive concomitant anti-epileptic drugs (AEDs) one of which must include levetiracetam or brivaracetam. Immediately after the last study drug intake by the participants in the double-blind period, participants will enter into a 2-year open label extension (OLE) period and continue receiving JNJ-40411813 as well as the AEDs during OLE period.

Group II: PlaceboPlacebo Group2 Interventions

Participants will receive JNJ-40411813 matching placebo (bid) up to 12 weeks. Participants will also receive concomitant AEDs one of which must include levetiracetam or brivaracetam during double blind period. Participants who had been receiving placebo in double blind period will start with the JNJ-40411813 dose in the OLE period.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

JNJ-40411813

2010

Completed Phase 2

~450

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for partial seizures, such as levetiracetam and brivaracetam, work primarily by modulating synaptic neurotransmitter release through binding to the synaptic vesicle protein 2A (SV2A). This binding inhibits abnormal neuronal firing and stabilizes neural activity, which is crucial for controlling partial seizures. These mechanisms are important for patients with partial seizures because they help reduce the frequency and severity of seizures, improving overall quality of life and reducing the risk of seizure-related complications.