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JNJ-40411813 + Standard Epilepsy Meds for Epilepsy
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- 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 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.I've had a brain scan in the last 10 years that ruled out progressive neurological disorders.I have had seizures that are not caused by epilepsy.I've had between 3 and 100 seizures each month for the last 6 months.You have had serious thoughts about harming yourself or have tried to harm yourself within the past 6 months.I am not allergic to the trial medication or its ingredients.I am currently taking 1-4 epilepsy drugs, including levetiracetam, without changes for the last month.I have been using nerve or brain stimulation therapy for 1 year or less.I am scheduled for epilepsy surgery soon or had it less than 6 months ago.I have been diagnosed with a generalized epilepsy syndrome.My weight is at least 40 kg.I have been diagnosed with Lennox-Gastaut Syndrome.I have not had a major psychotic disorder or severe depression with psychosis in the past year.Your body mass index (BMI) is between 18 and 35.I have been diagnosed with focal epilepsy for at least a year.My current medication for seizures isn't working well enough.My recent health checks, including blood tests and heart checks, show I am healthy.You have had a problem with using drugs or alcohol in the past year.I am currently taking vigabatrin.I've had a brain scan in the last 10 years that ruled out progressive neurological disorders.I haven't had cancer in the last 5 years, except for certain skin cancers or cervical cancer that's considered cured.I am currently taking 1 to 4 epilepsy medications, including levetiracetam, without changes for the last 2 months.I am between 18 and 69 years old.Your body mass index (BMI) should be between 18 and 35, and you should weigh at least 40 kilograms.You are not responding well to the medication levetiracetam, even after taking it for a while at the right dose.
- Group 1: Placebo
- Group 2: JNJ-40411813
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are recruitment efforts for this clinical trial ongoing?
"The clinical trial is currently recruiting participants, with the study having been first posted on 5/18/2021 and last updated on 11/9/2022 according to clinicaltrials.gov."
What are the researchers striving to achieve with this clinical trial?
"The aim of this study, which will run for 12 weeks with a baseline period, is to observe the number of seizures in participants. Secondary outcomes include safety and tolerability (as measured by adverse events) and the percent reduction in double-blind monthly seizure count. Additionally, this trial seeks to measure the plasma concentration of levetiracetam or brivaracetam during the OLE period."
Are there any health risks associated with JNJ-40411813?
"As this is a Phase 2 trial, there is only data supporting safety, rather than efficacy. Our team has given JNJ-40411813 a score of 2."
At how many different locations can patients participate in this clinical trial?
"To make things as convenient as possible for potential participants, the 7 sites recruiting patients for this trial are located in or near Nashville, DeLand, and Philadelphia. Other enrolment locations include 4 additional cities."
What makes this clinical trial innovative or unique?
"JNJ-40411813 has been under investigation since 2021 when Janssen Research & Development, LLC completed the first study. This research project involved 160 people and allowed JNJ-40411813 to reach Phase 2 of drug approval. As of now, there is one active trial being conducted by the same sponsor."
Are there specific inclusion criteria for participants in this clinical trial?
"Potential participants that suffer from seizures and are between 18-69 years old may be accepted into this trial. Currently, the goal is to enroll 160 patients."
Does this study have an upper age limit for participants?
"The age limit for this trial is 18 to 69, which means that 38 other trials are available for minors and 61 are available for seniors."
How many participants are in this research trial?
"One hundred and sixty patients that meet the pre-determined inclusion criteria are necessary for this study. These eligible participants can choose to take part in the trial at Vanderbilt University Medical Center located in Nashville, Tennessee or Accel Research Sites situated in DeLand, Florida."
Are there any other instances in which JNJ-40411813 has been tested?
"There is currently 1 active clinical trial for JNJ-40411813 with 0 trials in Phase 3. While several of the clinical trials for JNJ-40411813 are located in Malaga, Georgia, there are 84 locations around the world conducting trials for this medication."
Who else is applying?
What state do they live in?
What portion of applicants met pre-screening criteria?
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