What Can I Expect if I Participate in the Focal-Epilepsy Study?
When you arrive at the study clinic, a study doctor will inform you about the study and answer any questions you may have. Once you have read the informed consent form and understand the details of the study, including the risks and benefits, you can decide whether or not to sign the form. No study-related procedures will take place without a signed informed consent form.
Participation in any clinical research study is completely voluntary. You may decide to stop participating at any time. This will not affect the medical care you would otherwise receive.
The study doctor and medical staff at the facility will perform various tests to ensure that you meet the criteria to participate in the study.
You will be asked to record your seizures daily (every day) for 8 weeks to assess the frequency of seizures you are having. If the study doctor concludes that you meet the eligibility criteria, you will be assigned at random to either the investigational drug or placebo.
Note that if you go on to participate in the open-label extension period of the study, you will receive investigational drug for up to 1 year.
- Assignment to the investigational drug or placebo is done at random and neither you nor the study doctor will know what you have received (called double-blind)
- You will receive either the investigational drug or placebo to take once daily for 8 weeks during the double-blind period of the study and then if eligible, investigational drug for 1 year
- Your condition will be monitored thoroughly for the duration of the study as you maintain a daily seizure diary throughout the study