Padsevonil as adjunctive treatment of focal-onset seizures

  • STATUS
    Recruiting
  • participants needed
    10
Send
Updated on 19 February 2024

Summary

You are being asked to participate in this clinical research study because you have epilepsy associated with focal onset seizures (or sometimes called partial seizures), and your seizures are not well controlled with your current treatment. Seizures are caused by abnormal electrical disturbances in the brain. Focalonset seizures occur when this electrical activity remains in a limited area of the brain. The seizures can sometimes turn into generalized seizures, which affect the whole brain. This is called secondary generalization.

Description

The name of the study is ARISE (EP0091). This is a Phase II, multicenter, multinational, randomized, double-blind, placebo-controlled, five-arm dose-finding study to evaluate the efficacy and safety of padsevonil (the study drug) as an add-on treatment of focal-onset seizures in adult subjects with drug-resistant epilepsy (i.e., in adults whose seizures are not well controlled with the treatment they are on). 

Padsevonil is not yet approved for the treatment of epileptic seizures in epilepsy. The purpose of the current study is to investigate this medication in people with epilepsy. This study aims to test the effectiveness of padsevonil, given in addition to your current epilepsy treatment. The study also aims to see how safe padsevonil is and how well your body can tolerate it. Padsevonil is designed to better control seizures in people who are resistant to other therapies.

FAQ

Your participation in this study, ARISE (EP0091), could last up to 27 weeks. The first 4 weeks we will collect some baseline information about you and your seizures. Then you will be given a medication for a maximum of 16 weeks during the treatment period. Then there is a conversion or taper period of 3 to 4 weeks, and a follow-up visit will be performed 30 days after you took the last study medication. During your total participation, you will receive study medication for up to 20 weeks. One additional safety follow-up will be performed at approximately 6 months (±1 month) after the last dose of study medication in case you discontinue the study after you took the study medication for more than 3 weeks.

After approximately 20 weeks in the study (including 16 weeks under treatment), you may have the opportunity to decide to enroll in an open-label extension study, EP0093, in which all participants will receive padsevonil, or to discontinue the study drug. 

Details
Condition seizures,epilepsy
Age 18years - 90years
Clinical Study IdentifierTX6109
Last Modified on19 February 2024

Eligibility

How to participate?

Step 1 Connect with a study center
Message sent successfully.
We have submitted the information you provided to the research team at the location you chose. For your records, we have sent a copy of the message to your email address.
If you would like to be informed of other studies that may be of interest to you, you may sign up for Patient Notification Service.
Sign up

Send a message

Enter your contact details to connect with study team

Email

View email

Phone

Phone country flag

View phone
Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Preferred way of contact
Race
Ethnicity
Other language

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.