Clinical trials are research studies performed on human volunteers to evaluate a new treatment’s safety and effectiveness and to compare it to existing treatments. Clinical trials are the last stage of the drug development process governed by the Federal Drug Administration (FDA). They are also the safest way to identify drugs that effectively treat epilepsy. The FDA requires that drug companies evaluate potential therapies in clinical trials before approval for public use.
How to find a clinical trial for epilepsy?
You can find a comprehensive list of clinical trials by typing “epilepsy” into the condition or disease field on the National Institute of Health’s search tool. You can also try searching by seizure type or the name of a specific investigational treatment.
What are the eligibility requirements?
Clinical trials require the participation of both healthy volunteers and volunteers with the illness that the drug will treat. Researchers choose clinical trial participants based on eligibility requirements which vary by trial. Researchers design these criteria to help identify the most appropriate volunteers, or “subjects”, for the trial and to keep volunteers safe. Eligibility requirements may include age, gender, type and stage of a disease, previous treatment history, and other medical conditions.
What are the benefits of participation?
Well-designed and well-executed clinical trials offer a lot of benefits, including:
- The ability to play an active role in managing your healthcare
- The access to new, investigational medical treatments before they are publicly available
- Free treatment
- Access to expert medical care at leading healthcare facilities
- The knowledge that you are helping others by contributing to medical research that may save lives in the future
What are the risks of participation?
Clinical trials also pose potential risks, including:
- The investigational treatment may be no better or worse than the current standard of care
- The study treatment may not be effective
- You might end up in the control group and receive a placebo or the standard treatment
- You risk unpleasant, serious, or even life-threatening side effects from the investigational treatment
- The clinical trial protocol may be inconvenient for you, requiring too much of your time and attention, e.g. trips to the study location, additional medical treatments, hospital stays or complex dosage requirements
Is a Clinical Trial Right for You?
Every patient and every clinical trial is different. Each clinical trial has its own set of qualifications, time commitments, treatment regimen, and more. To determine if a particular trial is right for you, do as much research as you can. Meet with the research coordinator and ask them questions relevant to your health, the study, the requirements, and the time commitment. Questions such as those below can help you with your decision. You may have more or different questions, but these serve as a good starting point.
- What is the purpose of the study?
- What is the control for the study? Is there a placebo involved?
- How will the study affect my current treatment regimen?
- What do we already know about the medications that are being tested as part of the study?
- How long will the trial last?
- How often do I need to come to the clinic for the trial?
- What will happen during trial-related visits?
- Does the study require blood tests, MRI, or EEG?
- Where will the trial take place? Will I need to travel?
- How are the costs for the study covered? Do I need to pay for anything? Will my insurance cover this? Are there reimbursements for travel or childcare?
- What happens if I stop participating in the trial? How is my medical care handled?
- Is the long-term follow-up care part of the trial? What would it involve?
- Is the trial HIPAA compliant? Can anyone find out about my participation?
- If this drug works for my seizures, can I continue taking it even after the trial ends?