Clinic Visit 1: Screening for eligibility

You will be asked to sign a consent form granting your permission for the study team to ask questions and perform the screening tests and assessments to see if you qualify for the study.

You will be asked to keep a diary of the kinds of seizures you are having.

If you qualify for the study, you will be seen in the clinic again for 5 or 6 more visits over a period of about 2.5 to 3.5 months.

Clinic Visit 2: Starting the treatment

This is when you receive your study medication and instructions about how and when to take it.

This is Day 1 of your treatment journey.

2/3 of the patients will receive BHV-7000 and 1/3 of the patients will receive a placebo. (A placebo is a pill that has no active properties. It is important because it will help us to see if BHV-7000 has an impact on the type of seizures we are studying.)  The decision of who gets what is decided by a computer, chosen completely at random.

You will be asked to come back in 2 weeks.

Next Clinic Visits

One study has visits at Week 2, Week 4, and Week 8. The other study has an additional visit at Week 12.  You will come to the clinic for these visits that should last between 1 to 2 hours. Your study doctor will do some tests and talk with you about your progress and well-being. You will be asked to complete some questionnaires about how you are feeling.

When your participation in one of these studies is over, you may be able to roll over into a longer study with less frequent visits where everyone will receive BHV-7000.

Clinic Visit 7: If you do not roll over into the long-term safety study (or if you or your doctor decided you should stop the study sooner), you will be invited back to the clinic for a final follow up visit 2 weeks after you stop taking the study medication.