What to Expect
At Biohaven, it is extremely important to us that you are supported at every step of the trial. You will have access to medical professionals who can answer your questions. Your well-being is our absolute priority.
The study will involve roughly seven visits over the course of twelve weeks. At each visit, the doctor will go through a range of assessments with you to check on your mental and physical health and how you feel the study treatment is going. Each visit is expected to last approximately a couple of hours.
To be eligible to take part in this study you must be between the ages of 18 and 65, have been diagnosed with OCD or have had symptoms of OCD for at least a year, and be taking an OCD medication that you do not feel is fully helping with your condition. Please note that you do not need to have a formal OCD diagnosis, we can assess that for you.
Clinic Visit 1:
Qualification Screening
- You will be asked to read, sign and date a consent form granting permission for screening tests to confirm that you are eligible for the study.
- The first screening will be in person, and the second screening will be by phone.
- After these screenings, your doctor will let you know if you have qualified.
Clinic Visit 2:
Starting the Treatment
- This is where you return to the clinic to receive your medication and instructions, starting with your first dose the morning after this visit.
- 50% of patients will receive the study medication, Troriluzole.
- 50% will receive a placebo (A placebo is a treatment that has no active properties. It is very important because it will help us see if Troriluzole has an impact on OCD).
- Your treatment will start on a smaller dose first to allow your body to acclimate.
- You will be asked to come back in two weeks.
Clinic Visit 3:
Week Three Follow-Up
- This is where you get to chat about your progress with your doctor.
- If you and your doctor decide that you should continue with the trial, your dosage will be increased to the level it will remain for the rest of the trial.
Clinic Visits 4 & 5:
Weeks Four and Eight of Treatment
Your doctor will carry out a range of tests and have a chat with you about your progress and well-being.
Clinic Visit 6:
Week Ten of Treatment
- This is the last visit of this phase!
- Your doctor will again carry out a range of tests and have a chat with you about your progress and well-being.
Clinic Visit 7:
Two Weeks after Last Dose Follow-Up
- Two weeks after you take your last dose, we will invite you back for a final follow-up visit.
- If you choose to stop at any other part or the trial, or if your doctor suggests you stop, we will also ask that you please attend this visit.
