110 Participants Needed

JNJ-40411813 + Standard Epilepsy Meds for Epilepsy

Recruiting at 90 trial locations
SC
Overseen ByStudy Contact
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Janssen Research & Development, LLC
Must be taking: Levetiracetam, Brivaracetam
Stay on Your Current MedsYou can continue your current medications while participating
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

No, you will not have to stop taking your current epilepsy medications. The trial requires that you continue your existing anti-epileptic drugs (AEDs) at stable dosages throughout the study, except for possible dosage reductions due to side effects.

How is the drug JNJ-40411813 different from other epilepsy drugs?

JNJ-40411813 is being studied in combination with standard epilepsy medications to see if it can help reduce seizures in people with epilepsy. This drug is unique because it is being tested specifically for its potential to work alongside existing treatments, which might offer a new option for patients who do not respond well to current medications.12345

What evidence supports the effectiveness of the drug JNJ-40411813 for epilepsy?

The effectiveness of new antiepileptic drugs, like JNJ-40411813, is often evaluated through placebo-controlled add-on trials, which have been successful in identifying effective treatments for epilepsy. These trials compare the new drug with a placebo while patients continue their standard epilepsy medications, providing evidence of the drug's potential benefits.678910

Who Is on the Research Team?

JR

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Participants should have experience in maintaining a seizure e-diary
I am currently taking 1 to 4 seizure medications, including either levetiracetam or brivaracetam.
I have been diagnosed with focal epilepsy for over a year and have had 3-100 seizures monthly for the past 6 months.
See 12 more

Exclusion Criteria

You are having seizures that are not easily measured or tracked.
My depression has worsened in the last 6 months, but I am taking antidepressants.
I have had seizures that are not caused by epilepsy.
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

up to 8 weeks

Baseline

Participants undergo an 8-week prospective pretreatment baseline period to establish seizure count

8 weeks

Double-blind Treatment

Participants receive JNJ-40411813 or placebo in combination with AEDs to evaluate efficacy and safety

up to 12 weeks
Visits at baseline, weeks 4, 8, and 12

Open-label Extension

Participants continue receiving JNJ-40411813 and AEDs to evaluate long-term efficacy and safety

up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks
1 follow-up telephone visit

What Are the Treatments Tested in This Trial?

Interventions

  • JNJ-40411813
  • Placebo
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: JNJ-40411813Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials
1,022
Recruited
6,408,000+
Joaquin Duato profile image

Joaquin Duato

Janssen Research & Development, LLC

Chief Executive Officer since 2022

MBA from ESADE, Master of International Management from Thunderbird School of Global Management

Dr. Jijo James, MD profile image

Dr. Jijo James, MD

Janssen Research & Development, LLC

Chief Medical Officer since 2014

MD from St. Johns Medical College, MPH from Columbia University

Published Research Related to This Trial

Concerns have been raised about the safety of prolonged placebo exposure in epilepsy trials, as it may lead to uncontrolled epilepsy and an increased risk of sudden unexpected death, with a meta-analysis showing a 3- to 5-fold higher risk in participants on placebo.
The Research Roundtable in Epilepsy proposed new trial designs, such as active-control add-on trials and adaptive designs, to reduce placebo exposure while still ensuring rigorous evidence of the efficacy of new antiepileptic drugs.
Reducing placebo exposure in trials: Considerations from the Research Roundtable in Epilepsy.Fureman, BE., Friedman, D., Baulac, M., et al.[2017]
In a simulation study using data from 684,825 seizures, it was found that placebos consistently reduced seizure frequency, suggesting that some of the observed placebo effects in epilepsy trials may be due to the natural progression of the disease rather than the placebo itself.
Modifying trial design elements, such as study start time or reducing the baseline population, can significantly enhance the ability of an effective drug to show superiority over placebo, highlighting the importance of careful clinical trial design in epilepsy research.
Confusing placebo effect with natural history in epilepsy: A big data approach.Goldenholz, DM., Moss, R., Scott, J., et al.[2019]
Newer antiepileptic drugs developed since the 1990s, such as gabapentin and lamotrigine, offer wider therapeutic benefits, fewer side effects, and reduced drug interactions compared to older medications, making them safer options for treating epilepsy.
These newer drugs not only effectively reduce seizures but also have additional benefits, such as managing chronic neuropathic pain and providing mood stabilization or anti-anxiety effects, highlighting their potential for broader neurological protection.
[Newer antiepileptic drugs].Matsuura, M.[2018]

Citations

Reducing placebo exposure in trials: Considerations from the Research Roundtable in Epilepsy. [2017]
Confusing placebo effect with natural history in epilepsy: A big data approach. [2019]
Placebo-corrected efficacy of modern antiepileptic drugs for refractory epilepsy: systematic review and meta-analysis. [2018]
Adverse events, placebo and nocebo effects in placebo-treated paediatric patients with refractory focal epilepsies. Analysis of double-blind studies. [2014]
Evaluation of antiepileptic drug efficacy. A review of clinical trial design. [2018]
[Newer antiepileptic drugs]. [2018]
Differential improvement of the sleep quality among patients with juvenile myoclonic epilepsy with valproic acid: A longitudinal sleep questionnaire-based study. [2020]
Effects of levetiracetam on EEG abnormalities in juvenile myoclonic epilepsy. [2022]
Evaluation of JNJ-26489112 in patients with photosensitive epilepsy: a placebo-controlled, exploratory study. [2014]
[Newer antiepileptic drugs]. [2007]
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