Common Questions

Why would I want to switch my antiepileptic (seizure-prevention) medication?

One in three people taking antiepileptic medications still have seizures. While there are many medications to control seizures, these medications work differently for each person. Sometimes, there may not be an available medication that works for an individual person with epilepsy.

This clinical study is designed to determine if an investigational antiepileptic medication is effective in controlling partial-onset seizures as a mono-therapy (only take 1 seizure medication). Titration onto the study drug will be closely monitored by the medical staff at the research center.

How can I take control of my epilepsy?

Being positive - thinking about what you can do instead of what you cannot do - is important. Take control by learning more about epilepsy and its treatment options.

Be empowered through information and knowledge. Many people find that spending more time with a medical specialist by joining a clinical trial is empowering. They learn about their condition by being closely monitored through medical tests and daily seizure documentation. Additionally new antiepileptic medications are needed, and these can only occur through clinical trials.

Will it cost me anything to take part in this study?

There will be no cost to you for the study visits with medical specialists, procedures, and supplies related to this study. The study medication will be provided to you without charge.

Can I participate if I do not have health insurance?

Yes, you can participate even if you do not have health insurance.

Can I participate if the study doctor is not part of my health insurance network?

Yes, you can participate in the study at no penalty even if the doctor is not part of your health insurance network.

What is the name of the medication in this study?

If you qualify for the study, the study staff will tell you the name of the investigational medication during the informed consent process (see questions on Informed consent.)

How much time will the study take?

This study lasts up to 22 weeks. You will have to visit the study center at least 10 times.

After completion of the first 22 weeks of the study, you can also participate in an optional extension study. This will include the investigational study medication and care from an epilepsy specialist.

Should I tell my doctor about this study?

If you are thinking about taking part in this study, you may want to talk to your doctor. Tell your doctor about the study, how long it will last, and the name of the doctor(s) at the study center.

If you decide to participate, you should definitely tell your doctor. Information about your participation will help your doctor in making appropriate decisions about your care. The study doctor or nurse can talk to your doctor for you if you give them permission.

Why don't I qualify for this study?

You did not meet one or more of the criteria in the written research plan (the protocol) that the researchers must follow. These criteria are designed to help protect the health and well-being of research participants and to ensure that the medication is being studied correctly and the results of the study will be meaningful.

Do I have my choice of doctors who are doing this research study?

If there is more than one study center in your area, you may choose the one you prefer when you complete the pre-screener questionnaire.

Why are there no study centers in my area?

Doctors must meet strict criteria and guidelines in order to conduct clinical research studies. Because of this, there may not be a research doctor available in your area. If you pre-qualify for the study and give permission for us to contact you, we will let you know if a study center opens in your area.

What is informed consent?

Before you can decide if you want to take part in this research study, you will need more information. The informed consent process will give you this information.

During the informed consent process, you will learn the key facts about this clinical research study. A member of the study team will explain why the study is being done and what to expect if you participate. The informed consent discussion will cover the:

• Study design;
• Study medication
• Tests you will have
• Possible risks and benefits

You can, and should, ask questions. Click here to see a suggested list of questions.

During the study, the study doctor or nurse will be available to answer any questions you have, and will tell you about any new information that may affect your decision to continue to participate in this study.

What is the informed consent form?

If you decide to take part in this research study, you will receive an informed consent form to read and sign. The form summarizes the study and explains your rights as a participant. Signing it means that you understand the information about the study and you are volunteering to participate. You will be provided with a signed copy of the informed consent form.

If I begin the study and want to stop participating, can I?

Yes. At any time you may choose to withdraw your consent to participate without penalty or loss of benefits to which you may be otherwise entitled. If you have any questions now or at any time about this research study, your rights, or study-related injury, please do not hesitate to ask the study physician.

Who will have access to information about me?

Medical information gathered from this study will be reviewed and possibly submitted to the study sponsor, U.S. Food & Drug Administration (FDA) and other regulatory agencies. The purpose of reviewing your medical records is to ensure the accuracy of the information which is being collected. Your confidentiality will be maintained in accordance with applicable law, including HIPAA (Health Insurance Portability and Accountability Act). At no time will your personally identifiable information, including your name, be publicly disclosed. (e.g. in journal articles or scientific presentations).

What are the risks and benefits if I join this study?

A member of the clinical study team will discuss the potential risks and benefits of this study with you, and answer any questions you may have. It is important to know that you will be monitored closely by medical specialists, and during each study visit, the medical staff will check your health and seizure status closely, as well as checking with you about any problems related to the study medication.

Benefits of this study, at no cost to you, include:

• Care from an epilepsy specialist
• Investigational antiepileptic medication
• Study-related exams, tests and health monitoring

You will also:

• Get help in documenting your seizures and symptoms through a diary
• Receive compensation for travel, travel arrangements, or lodging for appointments for qualified participants
• Be part of the national epilepsy research community

What is a clinical research study?

Clinical research studies (also called clinical trials) are research studies in which people volunteer to help doctors find new ways to improve health and treat different diseases.

Treatment studies test new treatments, such as new drugs. They are done to find out whether new approaches to treatment are safe and effective.

What phase of clinical research study is this?

This is a Phase III (3) study.

Clinical research programs are conducted in 4 steps, called phases. The trials in each phase have a different purpose and help researchers answer different questions.

1. Phase I (1) trials: Researchers test an experimental drug or treatment in a small group of people (20-80) for the first time. The purpose is to evaluate its safety and identify side effects.
2. Phase II (2) trials: The experimental drug or treatment is given to a larger group of people (100-300) to evaluate its effectiveness and further evaluate its safety.
3. Phase III (3) trials: The experimental drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, and collect information that will allow the experimental drug or treatment to be used safely.
4. Phase IV (4) trials: After a drug is approved by regulatory authorities like the U.S. Food and Drug Administration (FDA), researchers often continue to evaluate the drug, seeking more information about risks, benefits, and optimal use. These studies are also sometimes required by regulatory authorities.

Source: the National Institutes of Health, NIH & Clinical Research, "How does clinical research work?" http://clinicalresearch.nih.gov/how.html, Accessed 11/04/10

Why should I participate in this clinical research study?

Current treatments for epilepsy have come from past clinical research. If you join this study, you will help researchers test a new medication to help control seizures. This medication may help other people with epilepsy in the future.