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

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What is this study about?

The ENACT Trial is a study focused on understanding the effects of a new treatment called ENX-101 for people with focal epilepsy, which is a type of epilepsy where seizures start in one part of the brain. The study aims to see how well ENX-101 works when used alongside other anti-seizure medications. Participants in the study will receive either the ENX-101 treatment or a placebo, which looks like the treatment but does not contain the active ingredient.

During the study, participants will take the medication in the form of tablets or capsules by mouth. The treatment period will last for up to eight weeks, during which the effects of the medication on seizure frequency will be closely monitored. The goal is to determine if ENX-101 can help reduce the number of seizures experienced by participants compared to those taking the placebo.

The study will also look at how many participants become seizure-free during the last 28 days of the treatment period and throughout the entire treatment period. This research is important for finding new ways to help people with focal epilepsy manage their condition more effectively.

1 beginning of treatment

Upon joining the study, you will start the treatment period. This period lasts from Day 1 to Day 56.

During this time, you will be taking the study medication, ENX-101, or a placebo. The medication is administered in the form of a capsule or tablet and is taken orally.

2 medication administration

You will take the study medication as an additional treatment along with your current antiseizure medications. You should continue taking your existing medications at stable doses as prescribed by your doctor.

The study medication is taken daily, and it is important to follow the dosage instructions provided by the study team.

3 monitoring and recording

Throughout the treatment period, you will be asked to keep a seizure eDiary. This involves recording any seizures you experience, including their frequency and type.

Accurate record-keeping is essential for evaluating the effectiveness of the study medication.

4 end of treatment period

At the end of the 56-day treatment period, your participation in the study will be evaluated based on the data collected from your seizure eDiary and any other assessments conducted during the trial.

The study aims to determine if there is a significant reduction in seizure frequency compared to the placebo.

Who Can Join the Study?

Must be a male or female aged 18 to 75 years.
Must have been diagnosed with focal (partial onset) epilepsy according to the International League Against Epilepsy (ILAE) 2017 classification.
Must be experiencing poorly controlled focal onset seizures, which are seizures that start in one area of the brain and may affect awareness or lead to convulsions.
Must have had at least 3 observable focal onset seizures every 28 days in the 3 months before the study starts, but less than 10 seizures per day.
Must have had at least 6 observable focal onset seizures during the 8-week period before the study starts, but less than 10 seizures per day.
Must have been treated with approved antiseizure medications (ASMs) for at least 2 years and currently taking 1 to 4 ASMs at stable doses for at least 28 days before the study starts.
Can use benzodiazepines (a type of medication) as rescue medication if used no more than once a week on average.
Female patients must either be of non-childbearing potential (cannot become pregnant) or, if of childbearing potential, must agree to use two effective methods of contraception or remain abstinent.
Male patients who are fertile must agree to use a condom or remain abstinent.
Must have a body mass index (BMI) between 18 and 40 kg/m².
Must be able to provide an imaging study (MRI or CT scan) from the last 10 years to rule out a progressive cause of epilepsy.
Must be capable of giving written informed consent to participate in the study.
Must be willing to have their data entered into a study participant database.
Must be able to keep an accurate seizure eDiary for the duration of the study.

Who Cannot Join the Study?

Patients who do not have focal (partial onset) epilepsy cannot participate.
Patients who are not taking 1 to 4 antiseizure medications cannot participate. Antiseizure medications are drugs used to control seizures.
Patients who are younger than 3 years old cannot participate.
Patients who are part of a vulnerable population cannot participate. Vulnerable populations include groups like children, pregnant women, or people with certain disabilities.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Katholieke Universiteit te Leuven	Leuven	Belgium
Hospital Universitario Y Politecnico La Fe	Valencia	Spain

Other Sites

Site Name	City	Country
Rheinische Friedrich-Wilhelms-Universitaet Bonn	Bonn	Germany
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer	Barcelona	Spain
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Hospital Ruber Internacional	Madrid	Spain
Epilepsie Instellingen Nederland Stichting	Zwolle	The Netherlands
Gesellschaft Fuer Epilepsieforschung	Bielefeld	Germany
Kempenhaeghe	Heeze	The Netherlands
Uyssmqzzmkrinspmhzjgn Gzuxmfa uve Melcgff Gizk	Marburg	Germany
Fgobvxits Pcua Lh Ixzgqbxzbbtyp Bpnbalhhz Drx Hhazbnhl Ucbzlpnbqcsxv Lv Pjg	Madrid	Spain
Hqobxcae Vfpb dmhxyfkv	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	14.10.2022
Germany	Not recruiting	14.10.2022
Spain	Not recruiting	14.10.2022
The Netherlands	Not recruiting	14.10.2022

Trial locations

Investigated drugs:

Enx-101

ENX-101 is a new medication being tested to see if it can help people who have focal seizures, which are a type of seizure that starts in one part of the brain. In this trial, ENX-101 is given to patients along with their regular seizure medications to see if it can reduce the number of seizures they have. The goal is to find out if adding ENX-101 to their treatment makes a difference compared to not adding it.

Focal Epilepsy – Focal epilepsy is a neurological disorder characterized by recurrent seizures that originate in a specific area of the brain. These seizures can manifest in various forms, including focal aware seizures, where the person remains conscious, and focal impaired awareness seizures, where consciousness is affected. The seizures may also evolve into bilateral tonic-clonic seizures, which involve both sides of the brain and result in convulsions. The progression of focal epilepsy can vary, with some individuals experiencing frequent seizures while others may have them less often. Over time, the pattern and frequency of seizures can change, potentially affecting different areas of the brain. The condition requires ongoing management to help control seizure activity.

Trial ID:

2022-501028-95-00

Protocol code:

ENX-101-005

NCT ID:

NCT05481905

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?