For this post, we relayed five of the nOCD community's most common questions about Biohaven's ongoing clinical trial for OCD to their team in New Haven, Connecticut. They also provided a helpful video, which you'll find at the end of this post. Thanks to Biohaven for answering these questions, and please contact us anytime if you have more!
Q: I filled out the pre-screening form. Why haven’t I heard from a study site with more information?
A: The sites for this clinical trial try to follow up within 24-48 hours of receiving a pre-screening form. If you only provided your email, be sure to check your junk folder in case the site’s email was flagged as spam/junk.
Q: How is this investigational medication going to be any different from the medication I’ve tried before?
A: Many people with obsessive-compulsive disorder– perhaps as many as 40-60%– do not respond adequately to first-line medications (typically the SSRI antidepressants like Prozac and Zoloft). In these cases, it is common to add a second medication, to build on or augment the effects of the first. Antipsychotics, glutamate modulators, and other serotonergic drugs like Buspar (buspirone) and Zofran (ondansetron) have all been studied for augmentation in clinical trials.
The glutamate modulator riluzole has also been studied in this role, and preliminary studies suggest that riluzole may improve OCD symptoms in treatment-resistant patients. We are studying trigriluzole, which acts in the body very similarly to riluzole, as a new way to augment current standard of care response. At Biohaven, we will explore glutamate modulation as a potential treatment option for the 40-60% patients with OCD not helped by first-line medications.
Whereas existing medications for OCD usually target the neurotransmitters serotonin and dopamine, trigriluzole targets the neurotransmitter glutamate, which has been implicated in the pathophysiology of OCD in both animal and human studies. Trigriluzole could provide an alternative to current options for augmentation of standard of care treatment due to its potential to modulate excessive glutamate, which may play a role in some cases of OCD.
Q: Why is this study only happening in the United States?
A: Due to the number of people needed to participate in this clinical trial and the complexities involved in global trials, it was determined that it would be most efficient to complete this trial exclusively in the United States. If additional OCD studies are required, it’s possible that these future studies could be conducted globally.
Q: Why might it be worth taking part in this study?
A: People participate in clinical trials for a variety of reasons. Clinical trial participants might want to try something new, and might be interested in receiving investigational medication, study-related evaluations, and medical care. And some feel that by volunteering they are contributing to science’s forward progress by helping researchers find better treatments for future patients.
Q: I feel stable right now. Why change something and risk getting worse again?
A: Participating in a clinical trial is a personal decision. If you feel your current treatment is working for you, you probably wouldn’t be an appropriate candidate for this trial. But if you don’t think your current treatment is working well enough, you might be interested in learning more.
That said, here's a bit more information on the overall profile of trigriluzole, the investigational medication in this study. It's a glutamate-modulating agent that was developed as a prodrug of riluzole. A prodrug is an inactive medication that is converted into the active form of a drug once it has been ingested. After a patient takes trigriluzole, the body converts it into the active drug riluzole, which was approved by the FDA in 1995 for the treatment of ALS (amyotrophic lateral sclerosis) and remains the only FDA-approved drug for this disease.
Additionally, riluzole has been studied in clinical trials in patients with OCD. As riluzole has been used since 1995 in the treatment of ALS, it has an established safety and tolerability profile. Trigriluzole, which was developed to avoid some of riluzole's limitations, might offer a number of advantages. Riluzole is dosed twice daily, whereas trigriluzole is dosed just once daily. Additionally, patients need to fast before and after taking riluzole, as food can affect its absorption. Trigriluzole does not require any special meal restrictions.
Patients who enroll in this study have the option to continue in an open-label phase at the end of the study phase, where every patient can try trigriluzole.
Thanks for your questions! Now here's a helpful video with Dr. Vlad Coric, CEO of Biohaven: