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Study of EQU-001 and Placebo for Patients with Uncontrolled Focal Seizures in Epilepsy

Fast replyRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying epilepsy, specifically a type called focal onset seizures. The trial is testing a new treatment called EQU-001, which is being used in addition to the current medications that participants are already taking. The purpose of the study is to evaluate how effective EQU-001 is in reducing seizures when compared to a placebo. Participants will receive either EQU-001 or a placebo, and the study will monitor changes in the frequency of their seizures.

The study will involve taking EQU-001 in the form of a soft capsule, which is taken orally. The trial will last for several weeks, during which participants will continue their usual epilepsy medications. The study will include a period where participants' seizure activity is observed and recorded. This will help researchers understand how EQU-001 affects seizure frequency and whether it provides any additional benefits over the current treatment.

Throughout the study, participants will be asked to keep a diary of their seizures and any changes they notice. This information will be used to assess the effectiveness of EQU-001 in managing focal onset seizures. The trial aims to provide valuable insights into whether this new treatment can help people with epilepsy who continue to experience seizures despite being on medication.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Enrollment
Upon joining the study, you will be enrolled and provided with detailed information about the trial. You will be asked to sign an informed consent form, confirming your understanding and willingness to participate.
You will need to maintain a stable dose of your current anti-seizure medications for at least four weeks before the trial begins.
Step 2
Baseline period
The trial begins with an 8-week baseline period. During this time, you will continue your current medication regimen without any changes.
You will be required to keep a detailed diary of your seizures, noting the frequency and type of each seizure.
Step 3
Randomization
After the baseline period, you will be randomly assigned to one of the treatment groups. This means you will either receive the study drug EQU-001 or a placebo.
The study drug will be administered in doses of either 20 mg or 60 mg per day, taken orally as a soft capsule.
Step 4
Treatment period
The treatment period lasts for 16 weeks. During this time, you will continue to take your assigned medication daily.
You will need to continue recording your seizures in the study diary and attend regular check-ups to monitor your health and the effects of the medication.
Step 5
Maintenance phase
The last 12 weeks of the treatment period are known as the maintenance phase. During this phase, the focus is on observing the long-term effects of the medication.
You will continue to take the study drug or placebo and maintain your seizure diary.
Step 6
End of trial
At the end of the trial, you will have a final evaluation to assess your overall health and any changes in your seizure activity.
You will be asked to return any unused medication and complete any final questionnaires or assessments.

Who can join the trial?

9 criteria

Must be between 18 and 65 years old.
Must have epilepsy with seizures that start in one part of the brain, known as focal epilepsy.
Seizures must not be controlled even after trying at least one anti-seizure medication in the last 2 years.
Currently taking 1 to 3 anti-seizure medications, with doses that have been stable for at least 4 weeks before starting the study. These doses must remain stable during the study.
If using a device like a vagal nerve stimulator (VNS), responsive neurostimulator (RNS), or deep brain stimulator (DBS), it must have been in place and working for more than a year, with settings stable for over 3 months.
Females who can have children must agree to use effective birth control methods during the study and for 30 days after the last dose, unless they are not sexually active.
Must be willing and able to keep an accurate study diary and follow the study rules.
Must have had a brain scan (MRI or CT) in the last 10 years that shows no other conditions like tumors or infections that could affect the study.
Must have at least 8 observable seizures during the 8-week period before starting the study, with at least 3 seizures in each 4-week period and no 21-day seizure-free period.

Who cannot join the trial?

9 criteria

Patients who do not have a diagnosis of epilepsy cannot participate.
Patients who are not experiencing focal onset seizures cannot participate. Focal onset seizures are a type of seizure that starts in one area of the brain.
Patients who are younger than 4 years old or older than 18 years old cannot participate.
Patients who are not willing or able to follow the study procedures cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have a history of drug or alcohol abuse cannot participate.
Patients who have participated in another clinical trial within the last 30 days cannot participate.
Patients who have a known allergy to the study medication or its ingredients cannot participate.
Patients who have a serious medical condition that might interfere with the study cannot participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Responsive
CHRU De Nancy
Vandoeuvre Les Nancy, France
Responsive
Hospices Civils De Lyon
Lyon, France
Responsive
Hospital Ruber Internacional
Madrid, Spain

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Investigated drugs

EQU-001 is a medication being studied to help people who have epilepsy and experience focal onset seizures. Focal onset seizures start in one part of the brain and can affect a person's awareness, movement, or feelings. This medication is being tested to see if it can reduce the number of seizures when used alongside other treatments. The goal is to find out if adding EQU-001 to a patient's current treatment plan can help control seizures better than using a placebo. The study is looking at how effective EQU-001 is in improving the lives of people with epilepsy by potentially offering better seizure control.

Ivermectin

What is already known about the treatment

EQU-001 – EQU-001 is administered orally in the form of tablets and is currently being studied in clinical trials for its effectiveness in treating epilepsy, specifically for uncontrolled focal onset seizures. This medication is not yet widely recognized in medical literature as it is still under investigation. It is intended to be used as an additional treatment alongside other epilepsy medications. EQU-001 works by modulating certain pathways in the brain to help reduce the frequency and severity of seizures. It is classified as an antiepileptic drug, which means it is designed to help control seizures in people with epilepsy.

Investigated diseases

Epilepsy – Epilepsy is a neurological disorder characterized by recurrent, unprovoked seizures. These seizures are episodes of disturbed brain activity that can cause changes in attention or behavior. The condition can manifest in various forms, including focal seizures, which originate in one area of the brain, and generalized seizures, which affect the entire brain. Focal seizures may further be classified into focal aware seizures, focal impaired awareness seizures, and focal to bilateral tonic-clonic seizures. The progression of epilepsy can vary, with some individuals experiencing frequent seizures and others having them less often. The severity and type of seizures can also change over time.