RecruitingOBSERVATIONAL

REACH: RWE Retrospective Study to Evaluate Cenobamate Impact on Health Care Resource Utilization

This study, called REACH, is looking at how a specific epilepsy medicine, cenobamate, impacts healthcare use for people with focal-onset seizures that aren't well controlled by other treatments. It's a 'retrospective observational study,' meaning researchers are looking back at existing medical records instead of testing a new treatment. They want to see if people use healthcare services (like doctor visits or hospital stays) more or less after they start taking cenobamate. The study involves looking at information from 200 patients in different countries to understand the real-world effects of this medication on healthcare needs.

At a glance

Status

Recruiting

Sponsor

Aziende Chimiche Riunite Angelini Francesco S.p.A

Enrolment target

200

Start

19 Dec 2024

Estimated completion

30 Dec 2025

Epilepsy With Uncontrolled Focal-onset Seizures

What is this study about?

REACH is a study that's investigating a medicine called cenobamate, which is used for a type of epilepsy where seizures start in one part of the brain and aren't fully controlled by other treatments. The main goal is to understand if using cenobamate changes how much healthcare people need. For example, do they have fewer hospital visits, fewer emergency room trips, or fewer appointments with specialists after starting the medication?

This isn't a study where new treatments are given; instead, researchers are looking back at existing medical notes and records. They're gathering information on 200 patients from several different clinics in various countries. By comparing the healthcare services these patients used before they started cenobamate with the services they used after, the researchers hope to learn more about the real-world impact of this medication.

The findings from this type of study can be very helpful. They can give doctors and patients a better idea of how cenobamate might affect a person's overall health and their need for various medical services. This information can help in making choices about epilepsy treatment in the future.

Key takeaways

This study looked at real patient medical records.
It focused on how cenobamate affects healthcare visits for people with hard-to-control seizures.
It aims to see if patients used fewer healthcare services after starting cenobamate.
No new treatments were given or tested in this study.
The results could help improve future epilepsy treatment decisions.

Who may be eligible?

To be included in this study, people needed to be at least 18 years old and have been diagnosed with epilepsy where their seizures start in one part of the brain and weren't fully controlled by their previous medicines. They must have been having at least one seizure a month in the six months before they started cenobamate.

The study also required people to have at least six months of medical records available from before they started cenobamate, and at least 12 months of records after they started it. This helps make sure there's enough information to compare their healthcare use over time. Also, participants needed to agree to their personal data being used according to privacy rules.

People were not included if they had certain other health conditions, such as progressive neurological diseases or specific epilepsy syndromes like LGS or Dravet. Those who were pregnant or breastfeeding, had severe substance or alcohol issues (not including caffeine or nicotine), or were already in another medical study, were also not eligible.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you at least 18 years old?
Do you have epilepsy with seizures that start in one area of the brain and weren't fully controlled by previous medicines?
Were you having at least one seizure a month before starting cenobamate?
Did you start cenobamate as part of your regular medical treatment (not in an experimental programme)?
Do you have medical records available from before and after starting cenobamate?

Answer every question to see your result.

What does participation involve?

If you were one of the patients included in this study, you wouldn't have had to do anything extra. This is a `retrospective` study, meaning researchers looked back at your existing medical records from before and after you started taking cenobamate. You wouldn't have had any additional appointments, tests, or changes to your medication as part of this study. The researchers simply collected anonymous information from your notes to understand patterns in healthcare use.

Potential risks and benefits

Because this study looked back at existing medical records, there were no direct risks or benefits to the patients whose data was used. Patients were not asked to do anything new or different, and their treatment was not changed. The main benefit is for future patients, as the study's findings could help doctors and patients make more informed decisions about epilepsy treatment and understand its wider impact on healthcare needs. Patients whose data was used also had the right to withdraw their consent for their data to be used, if they had provided it.

Locations (10)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Epilepsiezentrums am Neurozentrum des Universitätsklinikum Freiburg
Verified postcode
Freiburg im Breisgau, Germany· Not yet recruiting
Epileptologicum
Verified postcode
Hamburg, Germany· Not yet recruiting
Diakonie Kork, Epilepsiezentrum
Verified postcode
Kork, Germany· Not yet recruiting
Kempenhaeghe - Academisch Centrum voor Epilepsie
Verified postcode
Heeze, Netherlands· Not yet recruiting
Epilepsy Unit - Neurology Department Valle de Hebron Hospital
Verified postcode
Barcelona, Spain· Recruiting
Epilepsy Unit of the Neurology Department of the Hospital Clínico San Carlos
Verified postcode
Madrid, Spain· Recruiting
Consorcio Hosp. General Universitario Valencia
Verified postcode
Valencia, Spain· Recruiting
Department of Neurology, University Hospital Zurich
Verified postcode
Zurich, Switzerland· Recruiting
Institute of Neurosciences NHS Greater Glasgow and Clyde
Verified postcode
Glasgow, United Kingdom· Recruiting
Epilepsies - The Royal Wolverhampton NHS Trust
Verified postcode
Wolverhampton, United Kingdom· Recruiting

Common questions

What is cenobamate?

Cenobamate is a medicine used to help control focal-onset seizures, which are seizures that start in one part of the brain.

What does 'uncontrolled focal-onset seizures' mean?

This means that a person's seizures, which start in one area of the brain, are still happening regularly even though they are taking other epilepsy medicines.

Is this a new medicine being tested?

No, this study looks at people who have already been prescribed cenobamate in their usual medical care. It's not testing a new drug.

Will this study change my treatment?

No, this study is about looking at past records. It will not affect your current or future treatment plan.

Why is this research important?

It helps doctors and healthcare providers understand how cenobamate affects the amount of healthcare people need, which can improve future treatment decisions for epilepsy patients.

How to find out more

Lars Nicklasson

Lars.nicklasson@angelinipharma.com +46 702528077 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.