Study on the Effects of Azetukalner in Reducing Focal-Onset Seizures for Patients with Epilepsy

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What is this study about?

This clinical trial is focused on studying the effects of a medication called XEN1101 on individuals with focal onset seizures. Focal onset seizures are a type of epilepsy where seizures start in one area of the brain. The medication being tested, XEN1101, is taken in the form of a capsule and is being evaluated for its ability to reduce the frequency of these seizures. The study will compare the effects of XEN1101 to a placebo, which is a capsule that looks like the medication but does not contain the active substance.

The purpose of this study is to assess how well XEN1101 works in reducing the number of seizures experienced by participants. Participants will be randomly assigned to receive either XEN1101 or a placebo. The study will last for a period of 12 weeks, during which participants will take the capsules daily. Throughout the study, participants will be monitored to see if there is a reduction in the frequency of their seizures and to evaluate the safety and tolerability of the medication.

This trial is designed to provide valuable information on the potential benefits of XEN1101 as an additional treatment for people with focal onset seizures. The results will help determine if XEN1101 can be an effective option for managing this type of epilepsy. Participants will be required to keep a diary of their seizures to help researchers understand the impact of the treatment. The study aims to contribute to the development of new therapies for individuals living with epilepsy.

1 joining the study

Upon joining the study, you will be asked to provide written consent, confirming that you understand the nature and risks of the study.

You must have a diagnosis of focal epilepsy for at least two years and have tried at least two anti-seizure medications without achieving sustained seizure freedom.

2 baseline period

During this period, you will continue taking your current anti-seizure medications at a stable dose. This will last for at least one month before the study begins.

You will be required to keep an accurate diary of your seizures.

3 double-blind period

In this phase, you will receive either the study medication, XEN1101, or a placebo. The medication is in the form of a capsule taken orally.

The dosage and frequency of the medication will be determined by the study team, and you will continue this treatment throughout the double-blind period.

4 monitoring and assessment

Your seizure frequency will be monitored throughout the study. The primary goal is to assess whether there is a reduction in your seizure frequency.

You will be asked to report any changes in your condition and any side effects you experience.

5 end of study

At the end of the study, your overall response to the treatment will be evaluated.

You will be informed about the results and any next steps regarding your treatment.

Who Can Join the Study?

  • The person must be properly informed about the nature and risks of the study and must give written consent to participate.
  • The person must have been diagnosed with focal epilepsy for at least 2 years. This means they have a type of epilepsy where seizures start in one area of the brain.
  • The person must have tried at least 2 different anti-seizure medications (ASMs) at the right doses, but these did not stop the seizures completely.
  • The person must be taking a stable dose of 1 to 3 allowed anti-seizure medications (ASMs) for at least 1 month before the study starts and continue this during the study.
  • The person must be able to keep accurate records of their seizures in a diary.
  • The study is open to both males and females.
  • The study includes people who might be considered vulnerable, meaning they might need extra protection or care.

Who Cannot Join the Study?

  • Patients who do not have Focal Onset Seizures cannot participate.
  • Patients who are not within the specified age range cannot participate.
  • Patients who are not part of the specified clinical trial groups cannot participate.
  • Patients who are not male or female cannot participate.
  • Patients who are considered part of a vulnerable population cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Clinico San Carlos Madrid Spain
Centro Hospitalar Universitario Sao Joao E.P.E. Porto Portugal
Hospital Universitario Y Politecnico La Fe Valencia Spain

Other Sites

Site Name City Country Status
Pauls Stradins Clinical University Hospital Riga Latvia
Mnogoprofilna Bolnitsa Za Aktivno Lechenie Puls AD Blagoevgrad Bulgaria
Novo-Med Zielinski I Wspolnicy Sp. j. Katowice Poland
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Vivantes Netzwerk fuer Gesundheit GmbH Berlin Germany
Clinical Best Solutions Sp. z o.o. S.K. Lublin Poland
Gesellschaft Fuer Epilepsieforschung Bielefeld Germany
Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o. Nowa Sol Poland
Unidade Local De Saude De Entre O Douro E Vouga E.P.E. Santa Maria Da Feira Portugal
Unidade Local De Saude De Matosinhos E.P.E. Senhora Da Hora Portugal
Gk Neiroklinika Riga Latvia
Università degli studi Gabriele D’Annunzio Chieti-Pescara Centro di Studi e tecnologie avanzate Chieti Italy
Neurosphera Sp. z o.o. Warsaw Poland
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Philipps-Universitaet Marburg Marburg Germany
Universita’ Di Pisa Pisa Italy
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Epilepsiezentrum Kleinwachau gGmbH Radeberg Germany
Instituto Di Ricovero E Cura A Carattere Scientifico Bologna Italy
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Hospital Ruber Internacional Madrid Spain
Hospital Universitario 12 De Octubre Madrid Spain
Centrum Medyczne Neuromed Sp. z o.o. Bydgoszcz Poland
Hospital Clinico Universitario De Valladolid Valladolid Spain
Hospital La Milagrosa S.A. Madrid Spain
Ospedale Pediatrico Bambino Gesu’ Rome Italy
Beaumont Hospital Dublin Ireland
Forbeli s.r.o. Prague Czechia
Gkdsnw Uoqibgwtta Flycvukza Frankfurt Germany
Ksjinhkt dbm Ucuwvmxvlrti Mwxnmauu Apy Munich Germany
Uptpjfjqog Doift Svcww Dk Rfmj Lc Sqmzsnrd Rome Italy
Hrnnllir Vjrh dmpflfid Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Not recruiting
15.05.2023
Czechia Czechia
Not recruiting
15.05.2023
Germany Germany
Not recruiting
15.05.2023
Ireland Ireland
Not recruiting
15.05.2023
Italy Italy
Not recruiting
15.05.2023
Latvia Latvia
Not recruiting
15.05.2023
Poland Poland
Not recruiting
15.05.2023
Portugal Portugal
Not recruiting
15.05.2023
Spain Spain
Not recruiting
15.05.2023

Trial locations

Investigated drugs:

XEN1101 is a medication being studied to see if it can help reduce the number of seizures in people who have focal-onset seizures. Focal-onset seizures start in one specific area of the brain and can affect a person’s awareness or cause movements in parts of the body. This medication is being tested as an additional treatment, which means it is used along with other seizure medications that a person might already be taking. The goal of the study is to find out if XEN1101 is safe to use and if it can effectively lower the frequency of these seizures.

Focal Onset Seizures – Focal onset seizures, also known as partial seizures, begin in one specific area of the brain. They can cause a variety of symptoms depending on the brain region affected, such as unusual sensations, movements, or changes in behavior. These seizures may be classified as either aware or impaired awareness, depending on whether consciousness is maintained. As the seizure progresses, it can spread to other parts of the brain, potentially leading to a generalized seizure. The duration of focal onset seizures can vary, typically lasting from a few seconds to a couple of minutes. They may occur sporadically or in clusters, with frequency varying among individuals.

Trial ID:
2022-502000-73-00
Protocol code:
XPF-010-301
NCT ID:
NCT05614063
Trial Phase:
Therapeutic confirmatory (Phase III)

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