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Study on the Effects of XEN1101 and Placebo for Patients with 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 on individuals who experience Primary Generalized Tonic-Clonic Seizures. These seizures are a type of epilepsy that involves sudden and severe muscle contractions and loss of consciousness. The study aims to evaluate how well XEN1101 can reduce the frequency of these seizures when used alongside other treatments.

Participants in the study will be randomly assigned to receive either XEN1101 or a placebo, which is a capsule that looks like the medication but does not contain the active substance. The medication is taken orally in the form of a capsule. The study will last for a period of 12 weeks, during which the safety and effectiveness of XEN1101 will be closely monitored. The goal is to see if the medication can help reduce the number of seizures experienced by participants.

The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication and who is receiving the placebo. This helps ensure that the results are unbiased. The trial will also assess how well participants tolerate the medication and any potential side effects. The ultimate aim is to determine if XEN1101 can be a beneficial addition to existing treatments for those suffering from Primary Generalized Tonic-Clonic Seizures.

1 joining the study

Upon joining the study, you will be informed about the nature and risks involved. You will need to provide written consent to participate. If you are a minor, your legal representative or parent will provide consent on your behalf.

2 initial assessment

An initial assessment will be conducted to ensure you meet the study’s eligibility criteria. This includes confirming your medical history of primary generalized tonic-clonic seizures and reviewing any previous treatments you have received.

3 baseline period

During the baseline period, you will continue your current treatment regimen. You will be required to keep an accurate diary of your seizures. This period helps establish a baseline for your seizure frequency before starting the study medication.

4 randomization

You will be randomly assigned to receive either the study medication XEN1101 or a placebo. This process is double-blind, meaning neither you nor the study team will know which treatment you are receiving.

5 treatment phase

During the treatment phase, you will take the assigned medication orally in the form of a capsule. The dosage and frequency will be determined by the study protocol. You will continue to record your seizure activity in a diary.

6 follow-up visits

You will attend regular follow-up visits with the study team. These visits are designed to monitor your health, assess the effectiveness of the treatment, and address any side effects you may experience.

7 end of study

At the end of the study, a final assessment will be conducted. You will discuss your experience with the study team, and any necessary follow-up care will be arranged.

Who Can Join the Study?

  • The person must understand the study and its risks and agree to participate by signing a consent form. If the person is a minor, their legal guardian or parent must give consent.
  • The person must agree to follow the study’s rules about birth control.
  • Men must agree not to donate sperm from the start of the study until 3 months after the last dose of the study drug. Women must agree not to donate eggs from the start of the study until 6 months after the last dose of the study drug.
  • The person must have had a routine EEG (a test that measures brain activity) within 5 years before the study starts or during the initial phase of the study.
  • If the person has a device like a vagal nerve stimulator, it must have been implanted at least 5 months before the study starts, and the device settings should not change 30 days before the study and during the study.
  • The person must be able to participate for the entire duration of the study.
  • The person must have had probable or possible Primary Generalized Tonic-Clonic Seizures (PGTCS) for at least 1 year, as per specific medical guidelines, and be approved by the study committee.
  • The person must be on a stable dose of 1 to 3 allowed seizure medications for at least 1 month before the study starts and throughout the study.
  • The person must be able to keep accurate records of their seizures.
  • The person must be at least 12 years old and have a Body Mass Index (BMI) of 40 or less at the start of the study.
  • The person must have tried at least 2 different seizure medications at proper doses without achieving long-term seizure freedom.
  • The person must have started having PGTCS before the age of 40.
  • The person must have had a brain scan (CT or MRI) within the last 10 years after their seizures began, and the results must be available.
  • The person must have had at least 3 PGTCS in the 8 weeks before the study starts, confirmed by a seizure diary or reliable report from the person or their caregiver.

Who Cannot Join the Study?

  • Patients who do not have Primary Generalized Tonic-Clonic Seizures cannot participate. These are a type of seizure that affects the whole brain and causes convulsions.
  • Patients who are not within the specified age range cannot participate. The age range includes children, adolescents, and adults.
  • Patients who are not willing or able to follow the study procedures cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients with other significant health issues that might interfere with the study cannot participate.
  • Patients who are currently participating in another clinical trial cannot participate.
  • Patients who have a history of drug or alcohol abuse cannot participate.
  • Patients who have had a recent major surgery cannot participate.
  • Patients who have a known allergy to the study medication 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
Medical University Of Vienna Vienna Austria
Hospital Clinico San Carlos Madrid Spain
Centre Hospitalier Universitaire De Lille Lille France
Medizinische Universitaet Innsbruck Innsbruck Austria
Unidade Local De Saude De Lisboa Ocidental E.P.E. Carnaxide Portugal
Niepubliczny Zaklad Opieki Zdrowotnej Neuromed M. I M. Nastaj. sp.p. Lublin Poland
Unidade Local De Saúde De Santa Maria, E.P.E. Lisbon Portugal

Other Sites

Site Name City Country Status
Mnogoprofilna Bolnitsa Za Aktivno Lechenie Puls AD Blagoevgrad Bulgaria
Novo-Med Zielinski I Wspolnicy Sp. j. Katowice Poland
Universitair Ziekenhuis Gent Gent Belgium
Universitaetsklinikum Aachen AöR Aachen Germany
Vivantes Netzwerk fuer Gesundheit GmbH Berlin Germany
Gesellschaft Fuer Epilepsieforschung Bielefeld Germany
Kempenhaeghe Heeze The Netherlands
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
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Philipps-Universitaet Marburg Marburg Germany
Universita’ Di Pisa Pisa Italy
Universita’ Politecnica Delle Marche Ancona Italy
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
Hospital Universitario 12 De Octubre Madrid Spain
Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o. Nowa Sol Poland
Centrum Medyczne Neuromed Sp. z o.o. Bydgoszcz 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
Uniklinikum Salzburg Salzburg Austria
Cmhjkmbiw Uaktfoleceqnqf Spakfznan Woluwe-Saint-Lambert Belgium
Cyiodr Hsuchyltky E Utoogjkugtfvv Dw Cqzhyoy Emoxmy Coimbra Portugal
Ctvfwzreoe Pbeancn Lhrrfuiye Soc z okvs Gdansk Poland
Cfsahh Hbfkdsudwd Udezptvscikpd Dz Posrd Enthyb Porto Portugal
Cbxovuaz Hcxdkqyi Cbztvg Rryzlz Rijeka Croatia
Focmszkb nwvwdkzrl Mzhsr a Hozrlnh Prague Czechia
Gjnzbe Ulxgwpuxcu Fytcyzcth Frankfurt Germany
Kupxpuoo ddc Uzilacmgzqve Mcfizgia Alt Munich Germany
Uinexgntbq Degmt Sqfsq Dm Ratt Lt Sfyjhqhf Rome Italy
Jpgclulv Klrmeq Ubsmwxrwcm Linz Austria
Hhcqnpir Usgfyqpdmvhymc Siwhlqbntp &hznxeq Hettuin dr Hytxwsqulph 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
25.09.2023
Belgium Belgium
Recruiting
25.09.2023
Bulgaria Bulgaria
Recruiting
25.09.2023
Croatia Croatia
Not recruiting
25.09.2023
Czechia Czechia
Not recruiting
25.09.2023
France France
Recruiting
25.09.2023
Germany Germany
Recruiting
25.09.2023
Italy Italy
Recruiting
25.09.2023
Poland Poland
Recruiting
25.09.2023
Portugal Portugal
Recruiting
25.09.2023
Spain Spain
Recruiting
25.09.2023
The Netherlands The Netherlands
Recruiting
25.09.2023

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 a specific type of seizure called Primary Generalized Tonic-Clonic Seizures (PGTCS). This medication is used in addition to other treatments that the patient might already be taking for their seizures. The goal of using XEN1101 is to see if it can make these seizures happen less often, making it easier for patients to manage their condition. The study is designed to compare the effects of XEN1101 with a placebo to understand how well it works and how safe it is for patients.

Investigated diseases:

Primary Generalized Tonic-Clonic Seizures – Primary Generalized Tonic-Clonic Seizures are a type of epilepsy characterized by sudden and severe convulsions. These seizures involve both sides of the brain from the onset and typically result in a loss of consciousness. The progression of the seizure includes a tonic phase, where the body becomes rigid, followed by a clonic phase, where the body experiences rhythmic jerking movements. These seizures can occur without warning and may last for several minutes. After the seizure, individuals often experience confusion, fatigue, and muscle soreness. The frequency and severity of these seizures can vary among individuals.

Trial ID:
2022-502286-16-00
Protocol code:
XPF-010-303
NCT ID:
NCT05667142
Trial Phase:
Therapeutic confirmatory (Phase III)

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