Clinical trials are research studies that are designed to test a new approach, treatment, or test in people. This type of research is critical to developing new therapies for all types of epilepsy.
Thinking about participating in a clinical trial? We are here to help.
When we asked people with epilepsy why they did not participate in clinical trials, the number one response was that their doctor had never told them that one existed!
You spoke. We listened.
With our new Clinical Trials Portal, you’ll find a list of ongoing clinical trials in epilepsy. This tool will help connect you — people with epilepsy — to trials that match your epilepsy.
Clinical Trials FAQ
What is a clinical trial?
A clinical trial is a research study that looks at whether a new medical approach, treatment, or device is safe and effective for people. These studies also show which medical treatments work best for certain groups of people.
There are three phases of clinical trials research. People with epilepsy may be asked to join in studies at any one of these phases.
- Phase 1 – looks at overall safety of the treatment, and sets safe dosages to be used
- Phase 2 – looks at safety and early signs of effectiveness of a treatment in people with epilepsy
- Phase 3 – compares whether the new treatment added to a standard therapy controls seizures better than the standard therapy used alone
Why participate in a clinical trial?
People who enroll in clinical trials have the opportunity to help develop new therapies for epilepsy. Once an investigational drug or other therapy has completed pre-clinical testing, it is allowed to proceed by the FDA to clinical trials in people. Clinical trial volunteers are the first to receive the experimental therapy. Volunteers receive close monitoring.
All people in epilepsy clinical trials receive either the therapy being tested or best available standard treatment. However, it is important to understand that investigational treatments may be more or less helpful than standard treatment options. They also may have the same effectiveness to standard treatments. They may also be no better or worse than the standard treatment.
Clinical trials take place at epilepsy centers, hospitals, clinics, or doctors’ offices. A volunteer can withdraw from a clinical trial at any time.
Why are they so important?
- Clinical trials are the only way new treatments can be approved and made available to people with epilepsy.
- Clinical trials can help determine if a treatment is safe and effective.
How would participating in a clinical trial benefit you?
- Your personal contributions help advance epilepsy treatment and care.
- Participation may increase knowledge about conditions that affect you and those you love.
- People participating in study will have access to knowledgeable specialists and monitoring.
Why participate in an observational study?
Observational studies are conducted to better understand the causes of epilepsy, responses to standard medications or other treatments, or another aspect of living with epilepsy. Volunteers for an observational study continue to receive best available standard treatment and are closely monitored for outcomes like seizure frequency, quality of life, or other measures. Observational studies may involve visits to an epilepsy center or clinic, but are sometimes conducted completely on-line or by phone. A volunteer can withdraw from an observational study at any time.
What is the difference between an observational and an interventional trial?
These are the two main types of trials you will see posted on the Clinical Trials Portal:
- Observational – Researchers only collect information as a person moves through life. This doesn’t involve testing new treatments or changes in your regular epilepsy care.
- Interventional – Researchers collect data on a person’s health after they receive either a study therapy or a placebo (also called a control treatment). An interventional study may be open-label or masked/blinded.
- An open label study means that you and the researcher know whether or not you are taking the study therapy.
- A masked or blinded study means that you and the researcher do not know whether you are taking the study therapy or the control.
What does a placebo trial for epilepsy consist of?
A placebo is a treatment or therapy that does not have any expected benefit. When a medicine or other treatment looks helpful to control seizures, it needs to be tested against a placebo.
- This helps researchers know if it was the new medicine or treatment that worked or if it was something else.
- When a placebo is used in epilepsy trials, it is usually added to a person’s current standard treatments.
- Before joining a study using a placebo, make sure you talk about what it means with your own doctor as well as the research team.
Who can participate?
When you volunteer for a clinical trial of a study therapy, you are helping researchers learn:
- How helpful a treatment may be
- If a treatment is safe
- The best approaches to using the treatment
Because researchers don’t yet know whether the treatment works, it is not possible to say whether you will benefit from the treatment before you enter the study. The treatment may have risks, some of which may not be known. Some trials involve a placebo group, which means that if you are assigned to this group (usually by random selection), you won’t receive the experimental treatment during the trial but remain on your standard of care. If you wish to drop out of the study, you may do so at any time and for any reason.