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

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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
Semmelweis University Budapest Hungary
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Hospices Civils De Lyon Lyon France
Hopital Beaujon Clichy France
Hospital Clinico Universitario De Valladolid Valladolid Spain
Gesellschaft Fuer Epilepsieforschung Bielefeld Germany
Unidade Local De Saude Do Alto Ave E.P.E. Guimaraes Portugal
Cyaruwklx Ukntoykdjzptri Sxhfppxgl Woluwe-Saint-Lambert Belgium
Muutbaneivpxw Birbvriu Zd Ahvtynd Lddowfdl Pnae Ak Blagoevgrad Bulgaria
Hdooafkr Viuk dmpkscet Barcelona Spain
Bwubrzrm Hlhzyinx Dublin Ireland
Fwkneesk nwwnsmhqo Mbdco a Hifaqel Prague Czechia
Uyegdutmecpryedkdrvnn Tuotoomya Ani Tuebingen Germany
Prblhbtbqjdwaxxivvxyf Mfwcnkm Marburg Germany
Haqhxkjb Urbewqlspsqub Ffhoksrfp Jomtcbl Dotp Madrid Spain
Uthheivgyziefakfo Pqccfmpnull Dceke Mochtk Ancona Italy
Cujjbc Htgamrjjcr E Uhkogntezgxsh Dz Czkflwu Esuoqk Coimbra Portugal
Hfxznnbt Cayxnjm Sfo Cyzdzc Madrid Spain
Jnuvkcox Kbserk Ustxedrwyb Linz Austria
Mlxvxow Cwbvbp &owsbig Uptfacqmyp Ou Forkkgje Freiburg Im Breisgau Germany
Konyglbu dfp Uklykdvhrrmf Mlpfrewu Aww Munich Germany
Cwjeev Hteqdheofrn Ueruskjbamnmf Dp Ruhtka Rennes France
Uyjgqykiww Dxhym Stfmh Dt Rdyf Lf Swjcgnqc Rome Italy
Ivcmkhyp fyqm Koxxrwwxb Tsegvnlqjulaewoalko uii Icjmsgfrxxqh Udf gdkuh Ulm Germany
Uojorxodrgna Zzllrwmztt Gnfc Gent Belgium
Uwabpzoymqwnvjbrtqnix Aefgcf Aaj Aachen Germany
Hurxxjfu Uykflhwoatmfj 1v Db Osmegcq Madrid Spain
Ojqwjizb Pklitfkqdb Bscacsw Gfdbjwquyvr Rome Italy
Hwlbdxcv Uquqfjbzkceuzk Stzzuawyje &pzyvwx Hqzaspq dg Hdidgfbecfo STRASBOURG, Alsace France
Petry Segxqcxb Cksakuog Ucuvwkyhom Hvikmhqo Riga Latvia
Fyxnsaobi A Du Rxfztsgica Paris France
Aqspvbr Ujlqa Saakekzni Lbrexn Do Bqvjweg Bologna Italy
Mxwirhzcnokr Hyxlsjpu Fsm Aaxone Tahawzimz Il Negcxipig Anw Pwemaizagw Sjc Nsep Eep Sofia Bulgaria
Nzwjbcrk Zhdbcivai I Wogeynbza Sqs jz Katowice Poland
Uktdgrqhbl diebe splxc Gvqbxmjg Ddhnzaxjhf Ckfvizihszmzko Cjcmxg dj Sdmou e trikzxokwn alzxecul Chieti Italy
Mbfsvhz ckndui Odiksfdixfs Endd Sofia Bulgaria
Mmtwl Hmpnap Hobftsjlkv Nunnivrdwjs sruzan Hradec Kralove Czechia
Uvlgefhkwj Hnhmrsof Cfztnh Zijrkw Zagreb Croatia
Fzwcops swwbty Prague Czechia
Abcogyln cyssme jtilwskt Zagreb Croatia
Uybdlmoesrrdnnoib Df Pgis Pisa Italy
Cuxtapdsyr Ptockxt Ljpeicxlg Sis z owjc Gdansk Poland
Gcluru Ufejwyijei Flaoqpwtb Frankfurt Germany
Cdanxq Hczhogtudj Uebegbtkfbeut Do Pnpjm Elwspm Porto Portugal
Eufawlqnvbdlhygs Kuudwniwulz gufxt Radeberg Germany
Fsypabuess Izwsqsro Ntjpaqgjesi Nxdiuziwt Cdbltotq Mwdwrjb Pavia Italy
Vtwqdghl Nuqywfze fwtj Guplqvevbu Gmfr Berlin Germany
Hydzeddg Rwjem Ioslthrdrgudb Madrid Spain
Aggdldywyc Imhsrqfrl Dp Iyfghqjctgmbp Sokyfixkb Byxyhcopcl Barakaldo Spain
Mtg Csmujuff Rypeaamh Pfuoanu Bh Prheax Warsaw Poland
Ckqqfhbd Bsow Sbmhpirgv Szz z oxpg Smxx Lublin Poland
Tbiud Pqnfuedgdjk Ncrkaxvjobj Cdxuqxw Muqorqgs Smi z otzt Nowa Sol Poland
Cetfcay Mnrqsjdl Nsqxxdyd Sax z oqwd Bydgoszcz Poland
Kkljemapgpad Heeze The Netherlands
Uemgooj Llvsv Dj Ssrfi Dk Erzhe O Dtqmj E Vabpd Eiltil Santa Maria Da Feira Portugal
Udakahg Lcddv Dm Swuxj Dr Mlcooziire Etgdqm Senhora Da Hora Portugal
Utdiooz Luvth Dx Sqmpq Do Tyedispmjpixtj E Aeiw Ddptg Eqzmov Vila Real Portugal
Gd Ndrezhnrwddq Riga Latvia
Hpuruhls Lf Mrsvpfaxz Swfm Madrid Spain
Gnjkmfylwtwxi Slokagawkg Lqhwlx kqaeydqw Bpsiudpojyokwlviaksj mnl Salzburg Austria
Niwagzcswmh Sld z ozqh Warsaw Poland

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
Not 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
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)

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