Study on PRAX-628 for Adults with Focal Epilepsy Taking 1 to 3 Anti-Seizure Medications

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What is this study about?

This clinical trial is focused on studying the effects of a new treatment for Focal Epilepsy, a condition characterized by seizures that originate in one specific area of the brain. The treatment being tested is a medication called PRAX-628, which is taken in capsule form. The study will compare the effects of PRAX-628 to a placebo to determine its effectiveness in reducing the frequency of seizures in adults who are already taking one to three anti-seizure medications.

The purpose of the study is to evaluate how well PRAX-628 works in reducing the number of seizures experienced by participants. The study will be conducted over a period of several weeks, during which participants will be randomly assigned to receive either PRAX-628 or a placebo. Participants will continue their current anti-seizure medications throughout the study. The trial will involve regular monitoring and assessments to track changes in seizure frequency and any side effects experienced by participants.

Participants will be asked to keep a diary of their seizures and attend scheduled visits for assessments. The study aims to provide valuable information on the safety and effectiveness of PRAX-628 as a potential treatment option for individuals with Focal Epilepsy. This research could lead to improved management of seizures for those affected by this condition.

1 screening and observation period

During this period, you will be asked to keep a seizure diary for 9 weeks. This involves recording any seizures you experience, ensuring that you document them on at least 80% of the days.

You must have at least 8 countable focal seizures during this time. Countable focal seizures include those with clear signs, those with impaired awareness, or those that spread to both sides of the brain.

You should not be seizure-free for more than 21 consecutive days during this period.

2 randomization

After the screening period, you will be randomly assigned to receive either the PRAX-628 medication or a placebo. A placebo is a substance with no active medication, used to compare effects.

3 treatment period

You will take the assigned medication orally in the form of a capsule. The specific dosage and frequency will be provided by the study team.

This period will last for a specified duration, during which you will continue to record your seizures in the diary.

4 follow-up assessments

Throughout the trial, you will undergo regular assessments to monitor your health and the effects of the medication. This includes checking vital signs, laboratory tests, and other evaluations as needed.

You will also be asked about any side effects or changes in your condition.

5 end of trial

At the end of the trial, you will have a final assessment to evaluate the overall impact of the treatment on your seizure frequency and health.

The results will help determine the effectiveness and safety of PRAX-628 for treating focal seizures.

Who Can Join the Study?

The participant must be willing to sign a document that shows they understand the purpose of the clinical trial and agree to follow all the procedures and assessments required during the trial.
The participant must be between the ages of 18 and 75 at the time they agree to join the study.
The participant must have a diagnosis of focal onset epilepsy, which is a type of epilepsy where seizures start in one area of the brain.
Before joining the study, the participant must have had a CT or MRI scan that shows their epilepsy is not caused by a condition that is getting worse.
The participant must be taking stable doses of 1 to 3 anti-seizure medications (ASMs) for at least 4 weeks before the study starts. ASMs are drugs used to control seizures.
The participant must report having at least 4 countable focal onset seizures in the 4 weeks before the study starts and record at least 8 countable focal onset seizures during the observation period. Countable focal seizures include:
- Focal aware seizures with clear observable signs
- Focal seizures with impaired awareness
- Focal to bilateral tonic-clonic seizures, which are seizures that start in one part of the brain and spread to both sides, causing convulsions.
The participant must complete a seizure diary on at least 80% of the days during the observation period.
The participant must not be seizure-free for more than 21 consecutive days during the 9-week observation period. The pattern of seizures will be checked to ensure they are not only having clusters of seizures.

Who Cannot Join the Study?

Patients who do not have Focal Epilepsy cannot participate.
Patients who are not currently taking 1 to 3 Anti-Seizure Medications (ASMs) cannot participate. ASMs are drugs used to control seizures.
Patients who are younger than 18 years old or older than 65 years old cannot participate.
Patients who are part of a vulnerable population, such as those unable to give consent, cannot participate.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Niepubliczny Zaklad Opieki Zdrowotnej Neuromed M. I M. Nastaj. sp.p.	Lublin	Poland
Associazione La Nostra Famiglia	Conegliano	Italy
Hospital Clinico San Carlos	Madrid	Spain
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy
Futuremeds Sp. z o.o.	Wroclaw	Poland

Other Sites

Site Name	City	Country
Novo-Med Zielinski I Wspolnicy Sp. j.	Katowice	Poland
Fondazione Istituto Neurologico Nazionale Casimiro Mondino	Pavia	Italy
Hospital Del Mar	Barcelona	Spain
Mtz Clinical Research Powered By Pratia	Warsaw	Poland
Hospital Universitario Virgen De Las Nieves	Granada	Spain
Centrum Medyczne Neuromed Sp. z o.o.	Bydgoszcz	Poland
Hospital Clinico Universitario De Valladolid	Valladolid	Spain
Hospital Vithas La Salud	Granada	Spain
Hospital La Milagrosa S.A.	Madrid	Spain
Azienda Unita Sanitaria Locale Di Bologna	Bologna	Italy
Universita’ Campus Bio-medico Di Roma	Rome	Italy
Hospital Clinic De Barcelona	Barcelona	Spain
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Istituto Neurologico Mediterraneo Neuromed S.p.A.	Pozzilli	Italy
Fundacio Assistencial De Mutua De Terrassa Fpc	Terrassa	Spain
Azienda Sanitaria Locale Della Provincia Di Biella	Ponderano	Italy
Azienda Ospedaliera Universitaria Di Cagliari	Monserrato	Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Azienda Ospedaliero Universitaria Pisana	Pisa	Italy
Hkvetbdv Ucedtkrcmupwu Dz Lw Pqufkwny	Madrid	Spain
Nvicjnfnjdmu Zbueyx Ozforx Zjoxyxsjhx Wlgwiewmdorgfaszijpc Piaqkbqf Lbrhlylt Shejwvpw Lxqn Strjnnxhjupl	Katowice	Poland
Hsaddsex Do Lr Subrf Cjgh I Scnt Pbg	Barcelona	Spain
Uqmfwlpstr Dkwbm Sroin Dj Rotd Lo Stiasqpd	Rome	Italy
Hprmyagt Vgsr dvyfzjzv	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Italy	Not recruiting	01.09.2024
Poland	Not recruiting	01.09.2024
Spain	Not recruiting	01.09.2024

Trial locations

Investigated drugs:

Prax-628

PRAX-628 is a medication being studied for its ability to help reduce the frequency of focal seizures in adults. Focal seizures are a type of seizure that starts in one area of the brain. This medication is being tested to see if it can be an effective treatment for people who are already taking one to three other anti-seizure medications. The goal is to see if adding PRAX-628 can help control seizures better than the current treatment alone.

Focal Epilepsy – Focal epilepsy is a neurological condition characterized by recurrent seizures that originate in a specific area of the brain. These seizures can affect sensory perception, motor skills, or consciousness, depending on the brain region involved. The progression of focal epilepsy can vary, with some individuals experiencing an increase in seizure frequency or severity over time. Seizures may start with an aura, a warning sign that can include unusual sensations or emotions. As the condition progresses, seizures can become more complex, potentially spreading to other areas of the brain. The impact on daily life can vary widely among individuals, depending on the frequency and severity of the seizures.

Trial ID:

2024-514559-13-00

Protocol code:

PRAX-628-321

Trial Phase:

Therapeutic use (Phase IV)

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Study on PRAX-628 for Adults with Focal Epilepsy Taking 1 to 3 Anti-Seizure Medications

What is this study about?

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