The Power1 Study
Evaluating a new investigational medication for focal onset seizures
A study designed to fit your lifestyle.
You may be able to complete most study visits from home with approval from your study doctor.
If you or a loved one are between the ages of 18‑75 and continue to experience seizures despite taking available anti‑seizure medications, our study offers a new investigational medicine that may be able to help.
About the POWER1 Study
The POWER1 study is a research study evaluating a new investigational drug, in accordance with FDA requirements, as a potential treatment for focal onset seizures in adults.
Duration
Up to 9 weeks of screening, followed by a 12‑week treatment period, and 2 weeks of follow‑up.
Flexible Study Visits
You may complete most study visits from home. In some cases, only 2 in‑office visits are required, while the remaining visits can be done via telemedicine or at home.
No Cost
All expenses for travel and any other costs associated with the study will be paid for by the sponsor. This includes taxi or ride‑share to and from the study office if you are unable to drive.
Insurance is not required.
If you are considering joining this study, the first step is to answer a questionnaire about your health and medical history. If your answers show the study might be a good fit for you, you may choose to be referred to one of our trial navigators to learn more about the study.
Participation requirements are as followsa:
- 18 through 75 years old
- Currently experience seizures
- Take 1 or more anti‑seizure medications
aAdditional criteria to be assessed at screening.
Why take part?
If you qualify and decide to participate, you will receive:
- All study‑related care at no cost
- Close monitoring by an experienced doctor and study staff who understand epilepsy
- The opportunity to advance medical knowledge and potentially help others with epilepsy
Your safety is the highest priority while participating. If you have questions or concerns at any point throughout the research study, you will have a direct contact who you can engage for support at any time.
Your participation is voluntary. You are free to withdraw at any time, and for any reason. Your privacy will be maintained throughout the study.
What to expect if I participate?
- Complete the short health questionnaire to see if you pre‑qualify for the study. If eligible, you’ll have the option to speak with a trial navigator for details and next steps.
- On the call, you’ll learn more about the trial and discuss your health history. We’ll also guide you through releasing your medical history to confirm eligibility.
- Once your eligibility is confirmed, we’ll connect you with a local site for an enrollment call to review the Informed Consent Form and answer your questions.
- Once enrolled, you’ll receive clear instructions on at‑home tasks, appointment schedules, and visit requirements. Your health and safety will be closely monitored throughout the trial.
Frequently asked questions
About POWER1
The main purpose of this research is to see how well vormatrigine works for treating focal onset seizures compared with placebo, as well as its safety and side effects compared with placebo.
Vormatrigine is a new investigational medicine that is taken once a day and is currently being studied to see if it can help people with focal onset seizures. This study drug could potentially offer better seizure control with fewer side effects.
A placebo is an inactive material that looks like vormatrigine but does not contain any active study drug. Researchers use a placebo to see if the vormatrigine works better or is safer than taking nothing.
The study staff will provide you with more information about whether you will be able to continue your other medications. Please do not make any changes to your medications without first talking to your doctor and the study staff.
You can expect to be in the study for about 23 weeks.
Your participation in the research study is entirely voluntary and you may withdraw from the study at any time. You may decide to stop taking part in the study by notifying the study doctor of your decision.
Privacy, Costs, and Permissions
The study staff respects and protects your privacy and will not share your information, except as required by law, and will store your personal information with codes that protect your medical information. The Informed Consent Form will provide more information about how your privacy will be maintained.
There is no charge for taking part. All assessments and investigational drugs related to the research study are provided at no charge.
Your doctor does not have to give permission for you to participate; however, either you or the study doctor, with your permission, may contact your regular doctor to discuss your participation before you begin and keep your doctor updated about your participation. You will continue to see your regular doctors for routine office visits and checkups that you would normally have.
Clinical Trials
Clinical trials are central to our mission of delivering innovative medicines to individuals with specific diseases or conditions. A clinical trial is a research study that is conducted to determine whether an investigational medicine can improve an individual’s health. They depend entirely on the participation of patients and healthy volunteers.
Participants who meet all required eligibility criteria and are willing to participate in all study-related assessments, as described in the Informed Consent Form, may take part in a clinical trial.
To ensure that a research study is ethical, and that participants’ rights are protected, Institutional Review Boards review and approve study protocols that detail all aspects of how the study is conducted. In addition, study monitors, also known as clinical research associates, confirm that the study protocol procedures and research study requirements and regulations are being followed throughout the study.
An investigational drug is a medication that has not been approved by regulatory or health authorities (eg, the US Food and Drug Administration) for prescription use that is utilized to conduct clinical research studies. An investigational drug can also be called an experimental drug and is being studied to see if your disease or medical condition improves while taking it.