In short
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.
At a glance
- 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
What is ENX-101?
ENX-101 is a new medication being studied as a potential treatment for focal epilepsy. 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. 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. 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. 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). 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:
- Those receiving ENX-101 at a dose of 15mg daily
- Those receiving ENX-101 at a dose of 30mg daily
- 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:
- 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.
- 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:
- 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.