Study on the Long-term Safety and Tolerability of Azetukalner for Patients with Epilepsy, Including Focal-onset and Primary Generalized Tonic-Clonic Seizures

3 1 1

What is this study about?

This clinical trial is focused on studying the effects of a medication called XEN1101 in people diagnosed with epilepsy. Specifically, it looks at two types of seizures: focal-onset seizures, which start in one area of the brain, and primary generalized tonic-clonic seizures, which affect the whole brain. The medication being tested, XEN1101, is taken in the form of a capsule and is designed to help manage these types of seizures.

The purpose of this study is to understand how safe and tolerable long-term use of XEN1101 is for people with epilepsy. Participants in the study will take the medication over a period of time, and researchers will monitor them to see how they respond to the treatment. This includes looking at any side effects they might experience and how their seizure frequency changes. The study will also assess the overall impact on participants’ quality of life and any changes in their health over time.

Throughout the study, participants will be asked to take the medication regularly and attend scheduled check-ups. These check-ups will help researchers gather important information about the medication’s effects. The study aims to provide valuable insights into the long-term use of XEN1101 for managing epilepsy, which could help improve treatment options for people living with this condition.

1 joining the study

Upon joining the study, the participant will begin a long-term evaluation of the medication XEN1101, which is designed to assess its safety and effectiveness for individuals diagnosed with epilepsy.

The study is open-label, meaning that both the participant and the researchers will know which treatment is being administered.

2 medication administration

The participant will take the medication XEN1101 in the form of a capsule. The route of administration is oral.

The specific dosage and frequency of the medication will be determined by the study protocol and communicated to the participant by the study team.

3 monitoring and assessments

Throughout the study, the participant will undergo regular assessments to monitor the safety and tolerability of the medication. This includes tracking any side effects and changes in health status.

The participant will also be required to maintain accurate seizure diaries to record the frequency and severity of seizures.

4 evaluation of treatment effects

The study will evaluate the change in seizure frequency over time, comparing the baseline rate to each 4-week assessment period.

Additional assessments will include changes in quality of life and other health-related scores.

5 completion of the study

The study is expected to continue until September 2028, with the participant’s involvement lasting as long as they meet the study requirements and choose to remain in the study.

Upon completion, the participant will undergo final assessments to evaluate the long-term effects of the medication.

Who Can Join the Study?

  • The patient must have completed the previous study periods without leaving early and met all the necessary requirements. They should not have had any major issues or side effects that would prevent them from joining this long-term study.
  • The patient should be able to keep accurate records of their seizures.
  • The patient must be fully informed about the study, including its nature and risks, and must agree to participate by signing a written consent form before joining the study.
  • The patient must agree to follow the study’s rules about birth control as described in the study’s guidelines.
  • Male patients must agree not to donate sperm until 3 months after their last dose of the study medication. Female patients must agree not to donate eggs until 6 months after their last dose of the study medication.
  • The patient should be able to understand both spoken and written instructions and be willing to follow all the study schedules and requirements, according to the study doctor’s opinion.

Who Cannot Join the Study?

  • Patients who have not completed Study XPF-010-301, XPF-010-302, or XPF-010-303 cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who do not have the specific types of seizures being studied, such as Focal-onset Seizures or Primary generalized tonic-clonic seizures, cannot participate.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

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
Fondazione Istituto Neurologico Nazionale Casimiro Mondino Pavia Italy
Universitair Ziekenhuis Gent Gent Belgium
Universitaetsklinikum Aachen AöR Aachen Germany
Vivantes Netzwerk fuer Gesundheit GmbH Berlin Germany
Clinical Best Solutions Sp. z o.o. S.K. Lublin Poland
Gesellschaft Fuer Epilepsieforschung Bielefeld Germany
Centrum Medyczne Neuromed Sp. z o.o. Bydgoszcz Poland
Kempenhaeghe Heeze The Netherlands
Unidade Local De Saude De Tras-Os-Montes E Alto Douro E.P.E. Vila Real Portugal
Gk Neiroklinika Riga Latvia
Fondation A De Rothschild Paris France
Multiprofile Hospital For Active Treatment In Neurology And Psychiatry St. Naum EAD Sofia Bulgaria
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
Semmelweis University Budapest Hungary
Universita’ Di Pisa Pisa Italy
Universita’ Politecnica Delle Marche Ancona Italy
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Hospices Civils De Lyon Lyon France
Epilepsiezentrum Kleinwachau gGmbH Radeberg Germany
Centre Hospitalier Universitaire De Rennes Rennes France
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Hopital Beaujon Clichy France
Hospital Ruber Internacional Madrid Spain
Hospital Universitario 12 De Octubre Madrid Spain
Asociacion Instituto De Investigacion Sanitaria Biobizkaia Barakaldo Spain
Mtz Clinical Research Powered By Pratia Warsaw Poland
Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o. Nowa Sol Poland
Hospital Clinico Universitario De Valladolid Valladolid Spain
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
Unidade Local De Saude Do Alto Ave E.P.E. Guimaraes Portugal
Hospital La Milagrosa S.A. Madrid Spain
Ospedale Pediatrico Bambino Gesu’ Rome Italy
Beaumont Hospital Dublin Ireland
Forbeli s.r.o. Prague Czechia
Uniklinikum Salzburg Salzburg Austria
Altavita centar j.d.o.o. Zagreb Croatia
Cdvrhnzfu Ubzxnawbnpsnyi Soxwctaqs Woluwe-Saint-Lambert Belgium
Combtznqay Prljffx Ledotjqzq Sdx z omrt Gdansk Poland
Mmhrs Hmcwhl Hxpbirwbgl Nmegcksjomn ssknhu Hradec Kralove Czechia
Uznxhyuaae Hkxyksfv Crohrr Znrbld Zagreb Croatia
Mirxduu cpkvji Ottmdjsrman Exzs Sofia Bulgaria
Aynawwb Ucmjh Snqygpefr Lmhdua Df Bucqutq Bologna Italy
Fmbhiwjw nbqlnrufy Mblqg a Hltwdxo Prague Czechia
Gnezxv Uwhajeubhm Fzfnofdpn Frankfurt Germany
Cigzsq Hopjhzgzdh Uymvqulpehvsk Dw Ploku Erwcav Porto Portugal
Knrmxufp dfz Uzjqndeediqz Mgdloubd Aqc Munich Germany
Ujsqldhdle Ddkkx Sqrlm Dr Rmbe Lg Syloizcb Rome Italy
Jhgdibdj Kijsax Utvafpgybm Linz Austria
Hcrmpwsq Vnjw dsbvewpb Barcelona Spain
Hvjgwxvl Uakjpzqlvsodwa Sjqduufuih &gvzmjb Huosxtp dj Hcqryhnmqyu STRASBOURG, Alsace France

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

Trial status

Country Status Recruitment Start
Austria Austria
Recruiting
15.10.2023
Belgium Belgium
Recruiting
15.10.2023
Bulgaria Bulgaria
Recruiting
15.10.2023
Croatia Croatia
Recruiting
15.10.2023
Czechia Czechia
Recruiting
15.10.2023
Finland Finland
Recruiting
15.10.2023
France France
Recruiting
15.10.2023
Germany Germany
Recruiting
15.10.2023
Hungary Hungary
Recruiting
15.10.2023
Ireland Ireland
Recruiting
15.10.2023
Italy Italy
Recruiting
15.10.2023
Latvia Latvia
Not recruiting
15.10.2023
Poland Poland
Recruiting
15.10.2023
Portugal Portugal
Recruiting
15.10.2023
Spain Spain
Recruiting
15.10.2023
The Netherlands The Netherlands
Not yet recruiting
15.10.2023

Trial locations

Investigated drugs:

XEN1101 is a medication being studied for its safety and tolerability in people with epilepsy. It is designed to help manage seizures in patients who have already participated in previous studies. The trial aims to understand how well patients can tolerate this medication over a long period and to observe any potential side effects.

Focal-onset Seizures – These seizures begin in one specific area of the brain and can affect consciousness or awareness. They may cause unusual sensations, emotions, or movements, depending on the part of the brain involved. As the seizure progresses, it can spread to other areas of the brain, potentially leading to a generalized seizure. Symptoms can vary widely, including muscle twitching, changes in vision, or a sense of déjà vu. The duration of these seizures can range from a few seconds to a couple of minutes. They are often followed by a period of confusion or fatigue.

Primary Generalized Tonic-Clonic Seizures – These seizures involve the entire brain from the onset and are characterized by a combination of muscle stiffness (tonic phase) and rhythmic muscle contractions (clonic phase). They typically begin with a sudden loss of consciousness, followed by a period of muscle rigidity and then convulsions. The person may cry out, fall, and experience muscle jerks, often leading to a brief period of confusion or deep sleep afterward. These seizures usually last a few minutes and can be accompanied by a loss of bladder control or biting of the tongue. They are often followed by a period of drowsiness or confusion known as the postictal state.

Trial ID:
2022-502282-24-00
Protocol code:
XPF-010-304
NCT ID:
NCT05718817
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • Study on the Effectiveness and Safety of BHV-7000 for Adults with Refractory Focal Onset Epilepsy

    Recruiting

    4 1
    Investigated drugs:
    Denmark Finland Germany Greece Hungary Italy +5
  • Study of PRAX-628 to evaluate safety and effectiveness in adults with epilepsy who have focal seizures or generalized tonic-clonic seizures

    Recruiting

    3 1 1
    Investigated drugs:
    Germany Italy Poland Spain