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Long-term Safety Study of Adjunctive Troriluzole in Subjects with Obsessive Compulsive Disorder
EU CTIS ID: 2024-512108-20-00
What this study is testing
To evaluate the long term safety and tolerability of troriluzole as adjunctive therapy in subjects with OCD who have had an inadequate response to SSRI, clomipramine, venlafaxine or desvenlafaxine treatment.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Eligible subjects who complete study BHV4157-302 or BHV4157-303 and for whom the investigator believes open-label treatment offers an acceptable risk-benefit profile.
- Determined by the investigator to be medically stable at the final visit of BHV4157-302 or BHV4157-303, (the labs collected at the Week 10 visit for BHV4157-302 or BHV4157-303), as assessed by medical history, physical examination, laboratory test results, and electrocardiogram testing.
- Women of child bearing potential (WOCBP) and fertile men (including those vasectomized for less than 6 months) with female partners who are WOCBP (not having undergone bilateral tubal occlusion procedure and not post- menopausal) must agree to use highly effective birth control, including two methods of contraception, for the duration of the study.
You likely can't join if
- Subjects who did not successfully complete randomization phase in BHV4157-302/BHV4157-303 study.
- Acute suicidality or suicide attempt or self injurious behavior in last 12 months.
- Patients who plan to receive non-biological or biological investigational agent in while enrolled in trial.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Canada
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Canada; United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.