Long-term Safety Study of Adjunctive Troriluzole in Subjects With Obsessive Compulsive Disorder

A Multicenter, Long-Term Open-Label Safety Study of Adjunctive Troriluzole in Subjects With Obsessive Compulsive Disorder

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04708834

Enrollment

772

Registered

2021-01-14

Start date

2021-03-30

Completion date

2026-02-13

Last updated

2026-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obsessive Compulsive Disorder

Keywords

Obsessive compulsive disorder, OCD, troriluzole, Biohaven

Brief summary

The purpose of the study is to evaluate the long term safety and tolerability of troriluzole as adjunctive therapy in subjects with obsessive compulsive disorder (OCD).

Interventions

DRUGTroriluzole (BHV-4157)

200 mg daily first 2 weeks, 280 daily following first 2 weeks

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

Key Inclusion Criteria: * Eligible subjects are those 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 week 10 visit of BHV4157-302 or BHV4157-303, as assessed by medical history, physical examination, laboratory test results, and electrocardiogram testing. * It is required that all women of child-bearing potential (WOCBP) who are sexually active agree to use two methods of contraception for the duration of the study Key

Exclusion criteria

* Subjects who did not successfully complete 10 weeks of treatment in the BHV4157-302 or BHV4157-303 study. * Acute suicidality or suicide attempt or self injurious behavior in the last 12 months. * Patients who may have received a non-biological investigational agent in any clinical trial within 30 days or a biological agent within 90 days prior to entry, other than what was received in BHV4157-302 or BHV4157-303;

Design outcomes

Primary

Measure	Time frame	Description
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 desvenfaxine treatment	Change from Baseline to week 240	Percent change in treatment emergent adverse events, and clinical significant abnormalities in ECG's and lab values after Baseline.

Countries

Canada, Italy, Netherlands, Spain, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026