Study on the Effectiveness and Safety of Levetiracetam XR for Patients with Drug-Resistant Partial Onset Epilepsy

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What is this study about?

This clinical trial is focused on studying a condition known as Refractory Partial Onset Epilepsy, which is a type of epilepsy where seizures start in one part of the brain and are resistant to treatment. The study aims to evaluate the effectiveness and safety of a medication called Levetiracetam XR, which is an extended-release form of levetiracetam, used as an additional therapy for patients who have not responded well to other treatments. The trial will compare this extended-release form to the immediate-release form of levetiracetam, known as Keppra, as well as a placebo.

The purpose of the study is to see if Levetiracetam XR can reduce the frequency of seizures in patients with drug-resistant focal onset seizures. Participants in the study will receive either the extended-release levetiracetam, the immediate-release levetiracetam, or a placebo. The study will last for a total of 12 weeks, during which the participants will take the medication once daily. Throughout the study, the frequency of seizures will be monitored to assess any changes or improvements.

Participants will be asked to keep a diary of their seizures and any side effects they experience. The study will also look at how the treatment affects the participants’ quality of life and their satisfaction with the medication. The goal is to find out if Levetiracetam XR can offer a better treatment option for those with difficult-to-treat epilepsy, potentially leading to fewer seizures and an improved quality of life.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing the diagnosis of epilepsy with focal-onset seizures and ensuring stable doses of anti-seizure medication for at least four weeks prior to the study.

2 baseline observation

A baseline observation period of eight weeks is required to document seizure frequency. During this time, at least six seizures must be recorded to confirm drug-resistant focal-onset seizures.

3 randomization and treatment allocation

Participants are randomly assigned to receive either Levetiracetam XR, Keppra 500 mg film-coated tablets, or a placebo. The study is double-blind, meaning neither the participants nor the researchers know which treatment is being administered.

4 treatment phase

The treatment phase lasts for 12 weeks. Participants take the assigned medication once daily. The goal is to assess the reduction in weekly focal-onset seizure frequency compared to baseline.

5 monitoring and data collection

Throughout the treatment phase, participants are required to maintain a diary to record seizure activity and any side effects. Regular check-ins are scheduled to monitor progress and ensure compliance with the study protocol.

6 end of treatment evaluation

At the end of the 12-week treatment period, a final evaluation is conducted. This includes assessing changes in seizure frequency, quality of life, and overall satisfaction with the treatment.

Who Can Join the Study?

Participants must be male or female, aged between 12 and 80 years for Spain, Poland, and Bulgaria. In other countries, only adults are included.
Participants must be willing and able to provide an informed consent form, follow study procedures like completing an electronic diary, and take their regular anti-seizure medication and the study medication as instructed.
Participants must have a diagnosis of epilepsy with Focal-onset seizures (FOS), which are seizures that start in one area of the brain, with or without spreading to other areas.
Participants must be on stable doses of anti-seizure medication for at least 4 weeks before the study begins.
Participants must have drug-resistant FOS, meaning their seizures do not respond to 1-3 stable anti-seizure medications, and they must have had at least 6 seizures during an 8-week observation period.
If participants have a Vagal Nerve Stimulator (VNS), a device used to help control seizures, it must have stable settings for more than 3 months before the study and should not change during the study.
Females who can have children must use a highly effective form of birth control if they are not abstinent, starting 60 days before the study and continuing for 30 days after the study medication ends. This includes methods like hormonal contraception, intrauterine devices, or having a partner who has had a vasectomy.
Females who cannot have children must be surgically sterilized, have had a hysterectomy, or be at least 1 year past menopause.
Sexually active males with partners who can have children must agree to use an acceptable method of birth control consistently and correctly for 90 days after the last study medication is taken.

Who Cannot Join the Study?

Patients who do not have Refractory Partial Onset Epilepsy cannot participate. This means if your epilepsy is not resistant to treatment, you are not eligible.
Patients who are not experiencing Focal Onset Seizures (FOS), which are seizures that start in one area of the brain, are excluded.
Patients who are not within the specified age range for the study cannot participate. The study includes certain age groups, so if you are outside these groups, you are not eligible.
Both male and female patients are eligible, so gender is not a reason for exclusion.
Patients who are part of a vulnerable population may be excluded. This refers to groups who might need special protection in research, like children or those unable to give consent.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Azienda Ospedaliera Universitaria Universita’ Degli Studi Della Campania Luigi Vanvitelli	Naples	Italy
Samodzielny Publiczny Zespol Zakladow Opieki Zdrowotnej W Pruszkowie	Pruszkow	Poland
Associazione Oasi Maria S.S.Onlus	Troina	Italy
Policlinico “Tor Vergata”, Università degli Studi di Roma TOR VERGATA	Rome	Italy

Other Sites

Site Name	City	Country
Casa Sollievo Della Sofferenza	San Giovanni Rotondo	Italy
Universita Cattolica Del Sacro Cuore	Rome	Italy
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital Del Mar	Barcelona	Spain
Elias University Emergency Hospital	Bucharest	Romania
Specialized Hospital For Active Treatment Of Childrens Diseases Professor Ivan Mitev	Sofia	Bulgaria
Geniko Nosokomeio Thessalonikis George Papanikolaou	Thessaloniki	Greece
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.	Cracow	Poland
Gesellschaft Fuer Epilepsieforschung	Bielefeld	Germany
INEP medical s.r.o.	Prague	Czechia
Copernicus Podmiot Leczniczy Sp. z o.o.	Gdansk	Poland
Hospital La Milagrosa S.A.	Madrid	Spain
Wojewodzki Specjalistyczny Szpital Dzieciecy Im Sw Ludwika W Krakowie	Cracow	Poland
Krakowska Akademia Neurologii Sp. z o.o.	Cracow	Poland
Instytut Matki I Dziecka	Warsaw	Poland
Medical Center Neuro Ped Gen	Plovdiv	Bulgaria
General University Hospital Of Larissa	Larissa	Greece
Mnogoprofilna Bolnitsa Za Aktivno Lechenie Puls AD	Blagoevgrad	Bulgaria
Multiprofile Hospital For Active Treatment In Neurology And Psychiatry St. Naum EAD	Sofia	Bulgaria
Spitalul Clinic Judetean De Urgenta Bihor	Oradea	Romania
Spitalul Clinic Judetean De Urgenta Pius Brinzeu	Timisoara	Romania
University General Hospital Of Ioannina	Ioannina	Greece
Neurosphera Sp. z o.o.	Warsaw	Poland
Diagnostic-consultative center “Aleksandrovska” EOOD	Sofia	Bulgaria
Universita’ Campus Bio-medico Di Roma	Rome	Italy
Universita’ Degli Studi Di Verona	Verona	Italy
Semmelweis University	Budapest	Hungary
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Spitalul Universitar De Urgenta Bucuresti	Bucharest	Romania
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie	Cracow	Poland
Markhot Ferenc Oktatokorhaz Es Rendelointezet	Eger	Hungary
Fakultni Nemocnice U Sv Anny V Brne	Brno-Stred	Czechia
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD	Sofia	Bulgaria
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Emergency Institute For Cardiovascular Diseases And Transplant	Targu Mures	Romania
University First multiprofile hospital for active treatment Sofia St. Joan Krastitel EAD	Sofia	Bulgaria
Forbeli s.r.o.	Prague	Czechia
Fundeni Clinical Institute	Bucharest	Romania
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara	Chaidari	Greece
Diagnostic-Consultative Center 1 St Klementina Varna Ltd.	Varna	Bulgaria
Menwzcy Cwearf Vvai 1 Lmyj	Pleven	Bulgaria
Scaxnuud Cklkgl Jodeuqwl De Uqpxbve Brnhkz	Brasov	Romania
Mcziwqtd Myvrqlg Aldgnwg	Pleven	Bulgaria
Uecsqycyajgtsf Cbqsvly Kdkuohoaq	Gdansk	Poland
Iyeutatyfxxl Puscmruu Lnnyaebg Pmoup du hjof nh mwic Kovima Rofqiw	Lublin	Poland

Trial status

Country	Status	Recruitment Start
Bulgaria	Recruiting	31.01.2025
Czechia	Recruiting	31.01.2025
Germany	Recruiting	31.01.2025
Greece	Recruiting	31.01.2025
Hungary	Recruiting	31.01.2025
Italy	Recruiting	31.01.2025
Poland	Recruiting	31.01.2025
Romania	Recruiting	31.01.2025
Spain	Recruiting	31.01.2025

Trial locations

Investigated drugs:

Levetiracetam

Levetiracetam Extended Release (XR) is a medication used in this study as an add-on therapy for patients with epilepsy who experience partial onset seizures that are resistant to other treatments. The extended release form is designed to be taken once daily, allowing the medication to be released slowly over time to help control seizures more effectively throughout the day.

Levetiracetam Immediate Release (IR) is another form of the same medication used in the study for comparison. This version is released into the body more quickly and may require more frequent dosing. It is used to help manage seizures in patients with epilepsy, and the study aims to compare its effectiveness and safety to the extended release version.

Refractory Partial Onset Epilepsy – This is a type of epilepsy where seizures begin in a specific part of the brain and are resistant to treatment with standard anti-seizure medications. These seizures, known as focal onset seizures, can affect various functions depending on the brain area involved, such as movement, sensation, or consciousness. The condition is characterized by frequent and unpredictable seizures that can vary in intensity and duration. Over time, the persistence of these seizures can impact daily activities and quality of life. Despite medication, individuals with this condition continue to experience seizures, making management challenging. The focus is often on reducing seizure frequency and improving the individual’s overall well-being.

Trial ID:

2024-514499-42-00

Protocol code:

NXPLEVE/24/P3-6

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effectiveness and Safety of Levetiracetam XR for Patients with Drug-Resistant Partial Onset Epilepsy

What is this study about?

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Who Cannot Join the Study?