About FOCAL & GENERALIZED EPILEPSY
Focal epilepsy
causes seizures that begin in one small area of the brain. These
seizures can affect awareness, movement, or sensations in part of
the body, depending on where they start.
Generalized epilepsy
involves seizures that begin on both sides of the brain at the same time, often leading to a brief loss of consciousness or full-body movements.
The ENERGY program comprises three distinct clinical trials, the POWER2 study and the EMPOWER study. Each is designed to better understand and address the needs of people living with Focal Onset Seizures (FOS) or Generalized Epilepsy.
We are incredibly grateful to every participant who helped us move one step closer to advancing a potential new treatment option for adults living with focal epilepsy. If you are an adult living with focal epilepsy and are interested in joining a clinical trial, we invite you to learn more about the Power2 study.
An interventional study, which means participants receive a potential new treatment so researchers can see how it affects their health. This study aims to find out whether the new medication can safely help reduce seizures in people living with FOS.
Learn More
An observational study, which means participants do not receive a new treatment. Instead, researchers observe and collect information about people living with FOS and Generalized Epilepsy to better understand their experiences, symptoms, and how the condition affects daily life.
Learn More Together, these complementary studies aim to generate meaningful insights that will help advance care for individuals affected by epilepsy
Vormatrigine is an investigational medicine that is taken once a
day orally. Vormatrigine is a small-molecule drug designed to calm
overactive neurons without affecting normal neuronal function,
potentially offering better seizure control with fewer side
effects.
Vormatrigine has been designed to maximize its effects against overactive
sodium channels that are believed to cause seizure activity while minimizing
the blocking of normal activity needed for healthy brain function.
Two complementary studies, each with a different focus
STUDY CRITERIA
FOCAL ONSET SEIZURES (FOS)
GENERALIZED EPILEPSY
AGE
STUDY TYPE
CHOICE OF:
18 – 75
Investigational
Recruitment Complete
18 – 85
Investigational
At-home, in-clinic, or hybrid study participation: US, Europe, South America
18 – 75
Observational
At home participation: US
The current ENERGY studies being conducted by Praxis Precision Medicines are POWER2 (vormatrigine/investigational) and EMPOWER (observational).
After you complete the pre-screening questions, our system will generate which study you are pre-qualified for. You will then be asked to schedule a call to speak with a clinical trial navigator who will ask further questions to determine if you are a candidate to be referred to one of our study sites.
Anyone who has a diagnosis of focal onset epilepsy by a healthcare provider as defined by the International League Against Epilepsy (ILAE) and meets other study criteria can participate in POWER2. Anyone who has a diagnosis of epilepsy by a healthcare provider as defined by the International League Against Epilepsy (ILAE) can participate in EMPOWER.
A double-blind study means neither you nor the doctors know if you are receiving the investigational medication or a placebo. This helps keep the results fair and unbiased.
A placebo is something that looks like real medication but doesn't have any active ingredients in it. It will not harm you. It's used in research to help understand how an investigational medication or treatment works.
Open label means only the investigational medication is being given; there is no placebo or control. Our investigational studies include an option to participate in an open-label extension following completion of the initial controlled study.
You will still see your current neurologist and will be taking the investigational medication alongside your current epilepsy treatment, if eligible. Please do not make any changes to your medications without first talking to your doctor and the study staff.
Following completion of the open label extension, the investigational medication will be made available through an expanded access program for participants who showed clear benefits of this treatment based on local country requirements.
The call will cover an overview of the study as well as questions about your medical history and other important details to determine if you are pre-qualified to participate. The call should take around 30 mins or up to an hour if translation is required.
There is no charge for taking part in any of the ENERGY studies. All assessments and the investigational medication are provided at no cost to you.
Yes! Travel, lodging, and other related costs will be covered by Praxis Precision Medicines. You will not have to pay any study-related travel expenses.
Yes! Anyone living outside of the US can participate in POWER2. We provide assistance and coordination with relocation to any of our study sites in US, Europe, and South America. EMPOWER is only open to participants in the US.
Your participation in research studies are 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.
Your safety is our top priority. There are several steps taken to closely monitor your health throughout. Regular lab tests are done to check how your body is responding to the investigational medication and watch for any side effects. During the observational period, specific tests will be done to help track your baseline health before starting treatment.
At Praxis, we are redefining what's possible for those diagnosed with Focal Onset Seizures (FOS) and Generalized Epilepsy.
We're excited to be studying a potential new treatment called Vormatrigine (PRAX-628), developed to help reduce seizures and improve quality of life for people living with epilepsy.
ABOUT FOCAL & GENERALIZED EPILEPSY
Focal epilepsy
causes seizures that begin in one small area of the brain. These seizures can affect awareness, movement, or sensations in part of the body, depending on where they start.
Generalized epilepsy
involves seizures that begin on both sides of the brain at the same time, often leading to a brief loss of consciousness or full-body movements.
The ENERGY program comprises three distinct clinical trials, the POWER1 study, the POWER2 study and the EMPOWER study. Each is designed to better understand and address the needs of people living with Focal Onset Seizures (FOS) or Generalized Epilepsy.
We are incredibly grateful to every participant who helped us move one step closer to advancing a potential new treatment option for adults living with focal epilepsy. If you are an adult living with focal epilepsy and are interested in joining a clinical trial, we invite you to learn more about the Power2 study.
An interventional study, which means participants receive a potential new treatment so researchers can see how it affects their health. This study aims to find out whether the new medication can safely help reduce seizures in people living with FOS.
An observational study, which means participants do not receive a new treatment. Instead, researchers observe and collect information about people living with FOS and Generalized Epilepsy to better understand their experiences, symptoms, and how the condition affects daily life.
Together, these complementary studies aim to generate meaningful insights that will help advance care for individuals affected by epilepsy
Vormatrigine is an investigational medicine that is taken once a day
orally. Vormatrigine is a small-molecule drug designed to calm
overactive neurons without affecting normal neuronal function,
potentially offering better seizure control with fewer side effects.
Vormatrigine has been designed to maximize its effects against
overactive sodium channels that are believed to cause seizure
activity while minimizing the blocking of normal activity needed for
healthy brain function.
STUDY CRITERIA
FOCAL ONSET SEIZURES (FOS)
GENERALIZED EPILEPSY
AGE
STUDY TYPE
CHOICE OF:
18 – 75
Investigational
Recruitment Complete
18 – 85
Investigational
At-home, in-clinic, or hybrid study participation: US, Europe, South America
18 – 75
Observational
At home participation: US
The current ENERGY studies being conducted by Praxis Precision Medicines are POWER2 (vormatrigine/investigational) and EMPOWER (observational).
After you complete the pre-screening questions, our system will generate which study you are pre-qualified for. You will then be asked to schedule a call to speak with a clinical trial navigator who will ask further questions to determine if you are a candidate to be referred to one of our study sites.
Anyone who has a diagnosis of focal onset epilepsy by a healthcare provider as defined by the International League Against Epilepsy (ILAE) and meets other study criteria can participate in POWER2. Anyone who has a diagnosis of epilepsy by a healthcare provider as defined by the International League Against Epilepsy (ILAE) can participate in EMPOWER.
A double-blind study means neither you nor the doctors know if you are receiving the investigational medication or a placebo. This helps keep the results fair and unbiased.
A placebo is something that looks like real medication but doesn't have any active ingredients in it. It will not harm you. It's used in research to help understand how an investigational medication or treatment works.
Open label means only the investigational medication is being given; there is no placebo or control. Our investigational studies include an option to participate in an open-label extension following completion of the initial controlled study.
You will still see your current neurologist and will be taking the investigational medication alongside your current epilepsy treatment, if eligible. Please do not make any changes to your medications without first talking to your doctor and the study staff.
Following completion of the open label extension, the investigational medication will be made available through an expanded access program for participants who showed clear benefits of this treatment based on local country requirements.
The call will cover an overview of the study as well as questions about your medical history and other important details to determine if you are pre-qualified to participate. The call should take around 30 mins or up to an hour if translation is required.
There is no charge for taking part in any of the ENERGY studies. All assessments and the investigational medication are provided at no cost to you.
Yes! Travel, lodging, and other related costs will be covered by Praxis Precision Medicines. You will not have to pay any study-related travel expenses.
Yes! Anyone living outside of the US can participate in POWER2. We provide assistance and coordination with relocation to any of our study sites in US, Europe, and South America. EMPOWER is only open to participants in the US.
Your participation in research studies are 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.
Your safety is our top priority. There are several steps taken to closely monitor your health throughout. Regular lab tests are done to check how your body is responding to the investigational medication and watch for any side effects. During the observational period, specific tests will be done to help track your baseline health before starting treatment.
