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

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Biohaven

Status and phase

Invitation-only
Phase 3

Conditions

Obsessive Compulsive Disorder

Treatments

Drug: Troriluzole (BHV-4157)

Study type

Interventional

Funder types

Industry

Identifiers

NCT04708834
BHV4157-209

Details and patient eligibility

About

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).

Enrollment

1,200 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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;

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

1,200 participants in 1 patient group

Troriluzole (BHV-4157)
Experimental group
Description:
200 mg daily first 2 weeks, 280 daily for following 46 weeks
Treatment:
Drug: Troriluzole (BHV-4157)

Trial contacts and locations

175

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Data sourced from clinicaltrials.gov

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