Could More Seizure-Free Days Be in Your Future?
Participate in POWER2, an epilepsy study that offers the convenience of completing some visits from home.
If you or a loved one is between the ages of 18 and 85 years old and continues to experience epileptic seizures despite taking available anti-seizure medications, this study offers a new investigational medicine that may be able to help.
About the POWER2 study
The POWER2 study is a research study evaluating a new investigational medicine, in accordance with FDA requirements, as a potential treatment for focal onset seizures in adults.
Flexible Study Visits You may complete some study visits from home.
No Cost Any travel expenses and other costs associated with the study will be paid by the sponsor. Insurance is not required.
Duration Up to 6 weeks of screening, followed by a 12-week study treatment period and 2 weeks of follow-up.
If you are considering joining this study, the first step is to answer a questionnaire about your health and medical history. If you qualify, you can schedule time with one of our trial navigators to hear more about the study.
Why take part?
If you qualify and decide to participate, you will receive
- All study-related care at no cost, including travel expenses
- Close monitoring by an experienced doctor and study staff who understand epilepsy
- The opportunity to advance medical knowledge and potentially help others with epilepsy
If you ever have questions or concerns, 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.
Participation requirements are as follows
- 18 to 85 years old
- Take 1 to 3 anti-seizure medications
- Currently experience seizures
Additional criteria to be assessed at screening.
What to expect if I participate
- Complete the short health questionnaire to see if you prequalify.
- Schedule a call with a clinical trial navigator to hear more about the trial and to discuss your health history.
- After reviewing your medical information, if you’re eligible, we’ll connect you with a clinical trial site.
- If you decide to enroll in the study, you’ll receive clear instructions on participation and next steps.
Your safety is the highest priority. If you ever have questions or concerns, you can reach out to our team at any time.
About Praxis Precision Medicines
Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating insights from genetic epilepsies into the development of therapies for central nervous system, or CNS, disorders characterized by neuronal excitation-inhibition imbalance.
FAQ
Why is this study being conducted?
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.
What is the investigational medicine used in this study?
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.
What is a placebo?
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.
Can I continue taking medications for my other conditions during the study?
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.
Can I continue taking my current epilepsy medications?
Yes, you will be able to continue taking your current epilepsy medications. Please do not make any changes to your medications without first talking to your doctor and the study staff.
How long is the study?
You can expect to be in the study for about 20 weeks.
Can I withdraw from the study after I have started?
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.
What happens to my personal information?
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.
Do I have to pay to participate?
There is no charge for taking part. All assessments and investigational medicines related to the research study are provided at no charge.
Does my regular doctor have to give permission for me to participate?
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.
What is a clinical trial?
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.
Who can participate?
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.
Who oversees clinical trials?
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.
What is an investigational medicine?
An investigational medicine 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 medicine can also be called an experimental medicine and is being studied to see if your disease or medical condition improves while taking it.