Epilepsy can be difficult to control. About 56 percent of adults with epilepsy in the United States still have seizures despite taking anti-seizure medications (ASMs). Having uncontrolled seizures can cause physical and mental health problems, lead to more injuries, reduce quality of life, and even raise the risk of death.¹

However, advances in medical research are leading to new potential treatments for epilepsy, and you may be eligible to participate in clinical trials evaluating investigational drugs.² If you or your loved one has epilepsy, you may discover that participating in a clinical trial could be right for you.

See if You May Be Eligible for a Clinical Trial

Clinical trials are an essential part of medical research, in which new drugs, interventions, and standards of care are tested using volunteer participants. Every new drug for epilepsy — or any other condition — must go through a clinical trial process. This is an important step that couldn’t happen without people who volunteer to help advance research and bring new therapies to the market. There’s no guarantee that a clinical trial will lead to an effective new medication, but each study produces valuable data that can help researchers understand the disease better and, ultimately, improve health care and quality of life for people with epilepsy or other diseases.²

One clinical trial now recruiting participants who have epilepsy, the X-TOLE2 study, is testing a drug called XEN1101. This clinical trial aims to find out if adding XEN1101 to a standard ASM regimen can help reduce the frequency of focal seizures.³

Why Join a Clinical Trial?

There are many reasons to participate in clinical research. During a clinical study, your health and your epilepsy will be closely monitored. Study participants also play an important part in bringing new medications to market, which can benefit many people in the future who also have epilepsy.²

The X-TOLE2 Study

X-TOLE2 is an ongoing phase 3 study. The researchers are recruiting about 360 volunteers who have been diagnosed with focal epilepsy (epilepsy with focal seizures) for at least two years and still have seizures despite trying at least two different ASMs.³

Before and during parts of the study, participants will take a stable dose of between one and three ASMs from a list of allowed medications. In addition, participants will receive either a dose of XEN1101 (the investigational medication) or a placebo (a substance that looks like XEN1101 but contains no medicinally active ingredients). The study medication is taken orally once a day. Among other details, researchers intend to find out whether XEN1101, along with standard treatment, works better than standard ASMs alone to prevent focal seizures.³

Eligibility for Research Participation

The X-TOLE2 study will start with up to nine-and-a-half weeks of monitoring baseline seizure activity before treatment begins, followed by 12 weeks of treatment. Qualified participants who complete the 12-week treatment period can choose to enroll in an extension of the trial, during which they’ll continue to take XEN1101. Those who don’t enroll in the extension will be monitored for eight more weeks after treatment ends.³

The study is taking place in trial centers or clinics in the U.S. and other countries. Volunteers may be eligible to participate if they³:

• Are at least 18 years old
• Have been diagnosed with focal seizures for at least two years
• Have tried at least two ASMs at adequate doses, without experiencing sustained freedom from seizures
• Are treated with a stable dose of between one and three allowable ASMs for at least one month before screening and remain on these medications for the duration of the trial
• Are able to keep an accurate seizure diary

Participants cannot join in the study if³:

• You have a history of seizure types other than focal seizures
• Your seizures are related to drug or alcohol use, ongoing infection, tumors, or certain diseases
• You have experienced status epilepticus or repetitive seizures within the last 12 months
• You had neurosurgery or radiosurgery for seizures too recently
• It’s not medically safe for you to participate due to other medical conditions

If you meet the initial requirements, a study representative may discuss the additional eligibility criteria with you.

You will not have to pay for the study medication. You may receive a stipend for study visits. Reasonable reimbursement for ground travel (such as rideshare services) and study-related expenses may be provided. You will continue to receive medical care for epilepsy throughout the clinical study.⁴

See if You May Be Eligible for a Clinical Trial

Talk With Others Who Understand

MyEpilepsyTeam is the social network for people with epilepsy and their loved ones. On MyEpilepsyTeam, thousands of members come together to ask questions, give advice, and share their stories with others who understand life with epilepsy.

Do you or your loved one have epilepsy and interest in joining a clinical trial? Have you participated in a clinical trial before? Share your experience in the comments below, or start a conversation by posting on your Activities page.