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Enx-101

The ENACT trial is an exciting new study investigating the potential of ENX-101 as an additional treatment for patients with focal epilepsy. This clinical trial aims to evaluate how effective and safe ENX-101 is when used alongside current antiseizure medications in reducing seizure frequency for those still experiencing seizures despite their current treatment regimen.

Table of Contents

What is ENX-101?

ENX-101 is a new medication being studied as a potential treatment for focal epilepsy[1]. It is designed to be used as an adjunctive treatment, which means it is taken in addition to other antiseizure medications that a patient is already using[1]. The drug is currently undergoing clinical trials to evaluate its effectiveness and safety in patients who are still experiencing seizures despite taking one to four antiseizure medications.

What Condition Does ENX-101 Treat?

ENX-101 is specifically being studied for the treatment of focal epilepsy, also known as partial onset seizures[1]. Focal epilepsy is a type of epilepsy where seizures start in a specific area of the brain. These seizures can be further classified into three types:

  • Focal aware motor seizures with observable component: In these seizures, the person remains conscious but experiences uncontrolled movements in a specific part of their body.
  • Focal impaired awareness seizures: During these seizures, the person’s consciousness is affected, and they may appear confused or unresponsive.
  • Focal to bilateral tonic-clonic seizures: These seizures start in one area of the brain but then spread to both sides, resulting in a full-body convulsion.

How ENX-101 Works

ENX-101 is designed to be taken daily as an additional medication alongside a patient’s current antiseizure drugs[1]. While the exact mechanism of action is not provided in the available information, the drug aims to reduce the frequency of focal seizures in patients who are not achieving adequate seizure control with their current medication regimen.

The ENACT Clinical Trial

The effectiveness and safety of ENX-101 are being evaluated in a clinical trial called ENACT (ENX-101 as Adjunctive Treatment in Patients With Focal Seizures)[1]. This trial has the following key features:

  • Study design: It is a randomized, double-blind, placebo-controlled trial. This means that participants are randomly assigned to different groups, and neither the patients nor the researchers know who is receiving the actual drug or a placebo until the study is complete.
  • Participant groups: The study includes three groups of participants:
    1. Those receiving ENX-101 at a dose of 15mg daily
    2. Those receiving ENX-101 at a dose of 30mg daily
    3. Those receiving a placebo (a substance with no active ingredients)
  • Duration: The treatment period lasts for 56 days (8 weeks)

Expected Outcomes of the Study

The ENACT trial aims to measure several outcomes to determine the effectiveness of ENX-101[1]:

  1. Primary outcome: The main goal is to measure the median percent change in the frequency of focal seizures over a 28-day period, compared to the placebo group.
  2. Secondary outcomes:
    • The percentage of patients who experience a 50% or greater reduction in seizure frequency
    • The percentage of patients who become seizure-free during the last 28 days of treatment
    • The percentage of patients who remain seizure-free throughout the entire 56-day treatment period

Potential Benefits of ENX-101

If the ENACT trial demonstrates positive results, ENX-101 could offer several potential benefits for patients with focal epilepsy[1]:

  • Improved seizure control: ENX-101 may help reduce the frequency of focal seizures in patients who are not achieving adequate control with their current medications.
  • Additional treatment option: As an adjunctive therapy, ENX-101 could provide another tool for managing focal epilepsy, especially for patients who have tried multiple medications without success.
  • Potential for seizure freedom: The study aims to evaluate if some patients can achieve complete seizure freedom while taking ENX-101, which is the ultimate goal of epilepsy treatment.

It’s important to note that ENX-101 is still in the clinical trial phase, and more research is needed to fully understand its effectiveness and safety profile. Patients with focal epilepsy who are interested in this potential treatment should discuss it with their healthcare providers and consider participating in clinical trials if appropriate.

Aspect Details
Trial Name ENACT: A Study of ENX-101 as Adjunctive Treatment in Patients With Focal Seizures
Drug ENX-101
Condition Focal Epilepsy
Study Design Randomized, Double-blind, Placebo-controlled
Treatment Groups ENX-101 15mg daily, ENX-101 30mg daily, Placebo
Primary Outcome Median percent change in 28-day focal seizure frequency
Secondary Outcomes 50% responder rate, Seizure-free patients during last 28 days and entire treatment period
Treatment Duration 56 days

FAQ

  • What is the purpose of the ENACT trial? The ENACT trial is designed to evaluate the effectiveness and safety of ENX-101 when used as an additional treatment for patients with focal epilepsy who are still experiencing seizures despite taking 1 to 4 antiseizure medications.
  • How is ENX-101 administered in the trial? ENX-101 is administered as an adjunctive treatment, which means it is given in addition to the patient's current antiseizure medication. The trial includes two dosage groups: one receiving 15mg daily and another receiving 30mg daily.
  • What are the main outcomes being measured in the ENACT trial? The primary outcome is the median percent change in 28-day focal seizure frequency compared to placebo. Secondary outcomes include the percentage of patients achieving a 50% or greater reduction in seizure frequency and the percentage of patients who become seizure-free during the treatment period.
  • How long does the treatment period last in the ENACT trial? The treatment period in the ENACT trial lasts for 56 days (8 weeks), from Day 1 to Day 56.
  • What types of seizures are being studied in the ENACT trial? The trial focuses on focal seizures, which include focal aware motor seizures with observable components, focal impaired awareness seizures, and focal to bilateral tonic-clonic seizures.

Ongoing Clinical Trials on Enx-101

  • Study on ENX-101 for Treating Focal Epilepsy in Patients Using 1 to 4 Antiseizure Medications

    Not recruiting

    1
    Investigated drugs:
    Belgium Germany The Netherlands Spain

Glossary

  • Focal Epilepsy: A type of epilepsy where seizures originate in a specific area of the brain, rather than involving the entire brain at once.
  • Adjunctive Treatment: An additional treatment used alongside the primary treatment to enhance its effectiveness.
  • Antiseizure Medications: Drugs designed to prevent or reduce the frequency and severity of epileptic seizures.
  • Placebo: A substance with no active therapeutic effect, used as a control in testing new drugs.
  • Double-blind: A study design where neither the participants nor the researchers know who is receiving the actual treatment and who is receiving a placebo.
  • Randomized: A method of assigning participants to different treatment groups by chance, to reduce bias in the study results.
  • Efficacy: The ability of a treatment to produce a desired effect.
  • Focal Aware Motor Seizure: A type of seizure where the person remains conscious and experiences movement in a specific part of the body.
  • Focal Impaired Awareness Seizure: A seizure that affects a person's awareness or consciousness.
  • Focal to Bilateral Tonic-Clonic Seizure: A seizure that starts in one area of the brain but then spreads to involve both sides, causing stiffening and jerking of the entire body.
  • Responder Rate: The percentage of patients who experience a significant reduction in seizure frequency in response to a treatment.

References