Troriluzole (BHV-4157) in Adult Participants With Obsessive Compulsive Disorder

Inclusion Criteria:

1. Primary diagnosis of OCD as per the Diagnostic and Statistical Manual of MentalDisorders, 5th edition (DSM-5).

2. Participants must be currently experiencing non-response or inadequate response totheir current standard of care (SOC) medication defined as:

3. Participant Yale-Brown Obsessive Compulsive Scale total score must be ≥ 19 atscreening and Baseline, reflecting moderate or severe OCD symptoms.

4. Participants must currently be on a SSRI, clomipramine, venlafaxine ordesvenlafaxine.

5. Determined by the investigator to be medically stable at baseline/randomization asassessed by medical history, physical examination, laboratory test results, andelectrocardiogram testing. Participants must be physically able and expected tocomplete the trial as designed;

6. Minimum of 6 years of education or equivalent and sufficiently fluent in English tocomplete necessary scales and understand consent forms;

7. Participants must have adequate hearing, vision, and language skills to performneuropsychiatric testing and interviews as specified in the protocol;

8. Participants must be able to understand and agree to comply with the prescribeddosage regimens and procedures; report for regularly scheduled office visits; andreliably communicate with study personnel about adverse events and concomitantmedications;

9. It is required that all women of child-bearing potential (WOCBP) who are sexuallyactive agree to use two methods of contraception for the duration of the study (i.e.beginning 30 days prior to baseline and extending to 30 days after the last dose ofstudy drug).

10. WOCBP must have a negative serum pregnancy test at screening and a negative urinepregnancy test prior to dosing at Baseline;

11. It is required that men who are sexually active with WOCBP agree to use 2 methods ofcontraception for the duration of the study (beginning at first treatment andextending to 90 days after the last dose of study drug).

12. The duration of the subject's OCD disease was to be ≥ 1 year.

13. In addition, subjects had to be on stable doses of other psychotropic medication forat least 12 weeks prior to screening.

14. Subjects had to have a Clinical Global Impression of Severity Scale (CGI-S) score of ≥ 4 at screening and baseline.

Exclusion Criteria:

1. Participants should be excluded with a history of more than 2 previous failedtreatment trials of SSRIs, clomipramine, venlafaxine, or desvenlafaxine (notincluding the current SSRI trial) given for an adequate duration at an adequate doseas defined by the following criteria taken from the Massachusetts General HospitalTreatment Response Questionnaire for OCD (MGH-TRQ-OCD) as follows:

2. Treatment failure / non-response: As per the MGH-TRQ-OCD, there has beenminimal or no meaningful clinical benefit as perceived by the participantdespite an adequate dose and duration of treatment;

3. Adequate duration: At least 10 weeks of treatment with SSRI, clomipramine,venlafaxine, or desvenlafaxine

4. Adequate dose: Defined by the the United States Prescribing Informationlabeling.

5. Evidence at screening or baseline of any medical or psychiatric condition other thanOCD that could predominantly explain or contribute significantly to the subjects'symptoms or that could confound assessment of OCD symptoms

6. Mini Mental State Examination (MMSE) score of < 24 at Screening

7. Current or prior history, per DSM-5 criteria, of bipolar I or II disorder,schizophrenia or other psychotic disorders, schizoaffective disorder, autism orautistic spectrum disorders, borderline personality disorder, antisocial personalitydisorder, body dysmorphic disorder, hoarding disorder (symptoms of hoarding disorderas part of the OCD diagnosis are allowed, but a primary diagnosis of hoardingdisorder is excluded); a current diagnosis of Tourette's disorder is also excluded;

8. Any eating disorder within the last 12 months;

9. Acute suicidality or suicide attempt or self-injurious behavior in the last 6months;

10. History of psychosurgery, Deep Brain Stimulation (DBS) or Electroconvulsive Therapy (ECT).

11. Transcranial Magnetic Stimulation (TMS) is prohibited within 3 months prior toscreening and during the study.

12. Participants who may have received a non-biological investigational agent in anyclinical trial within 30 days, or a biological agent within 90 days prior toscreening are excluded.

13. Creatinine ≥ 2 mg/dL.

14. Course of treatment for participants with localized cancers (without metastaticspread) is 5 years prior to screening.

15. QTcF (Fridericia) interval ≥ 470 msec during the screening or baseline period oruncontrolled arrhythmia or frequent premature ventricular contraction (PVCs) (> 5/minute) or Mobitz Type II second or third degree atrioventricular (AV) block orleft bundle branch block, or right bundle branch block with a QRS duration ≥ 150msec or intraventricular conduction defect with a QRS duration ≥150 msec or evidenceof acute or sub-acute myocardial infarction or ischemia and added or otherelectrocardiogram findings that, in the investigator's opinion, would precludeparticipation in the study.

16. Previous treatment with riluzole