A research study investigating troriluzole (BHV-4157) as a possible treatment for Obsessive Compulsive Disorder (OCD)

Phase 1

Conditions: Obsessive Compulsive Disorder
MedDRA version: 20.0Level: LLTClassification code 10002860Term: Anxiety disorder NECSystem Organ Class: 100000004873
Therapeutic area: Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04]

Registration Number: EUCTR2020-004653-69-NL

Lead Sponsor: Biohaven Pharmaceuticals, Inc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 700

Inclusion Criteria

1.Primary diagnosis of OCD as per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition as confirmed by the MINI at Screening; The duration of the subject’s illness must be = 1 year;
2.Subjects must be currently experiencing non-response or inadequate response to their current SOC medication defined as: Subjects Y-BOCS total score must be = 22 at Screening and Baseline, reflecting moderate or severe OCD symptoms.
3.Subjects must currently be on an SSRI (with the exception of fluvoxamine, see Section 1.1.3), or clomipramine, venlafaxine or desvenlafaxine monotherapy treatment for an adequate duration and at an adequate dose defined as clinical trial protocol
4.Subjects must be on stable doses of other psychotropic medication (with exclusions specified below) for at least 12 weeks prior to screening;
5.CGI-S score of = 4 at screening and baseline;
6.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 postmenopausal) must agree to use highly effective birth control, including two methods of contraception, for the duration of the study (i.e., beginning 30 days prior to Baseline and extending to 30 days for women and 90 days for men after the last dose of study drug). The two methods of contraception should include:
i.One barrier method (e.g. diaphragm with spermicide, condom with spermicidal gel, cervical cap);
ii.One other method that could include hormonal contraceptives (e.g. combined estrogen and progesterone containing, or progesterone only with oral, vaginal, injectable, or transdermal route of administration), intrauterine device, or intrauterine hormone releasing system used for at least 4 weeks prior to sexual intercourse
7.WOCBP must have a negative serum pregnancy test at screening and a negative urine pregnancy test within
approximately 24 hours prior to dosing at Baseline
8.It is required that men who are sexually active with WOCBP agree to use two methods of contraception for the duration of the study (beginning at first treatment and extending to 90 days after the last dose of study drug).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 600
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

1.Subjects with a history of more than two (2) previous failed or inadequate treatment classes SSRIs, clomipramine, venlafaxine, or desvenlafaxine, given for an adequate duration at an adequate dose as defined by the criteria taken from the MGH-TRQ-OCD .
2.Subjects should be excluded at screening or baseline if any medical or psychiatric condition other than OCD, as specified in the inclusion criteria, could predominantly explain or contribute significantly to the subjects’ symptoms or that could confound assessment of OCD symptoms;
3.Current or prior history, per DSM-5 criteria, of bipolar I or II disorder, schizophrenia or other psychotic disorders, schizoaffective disorder, autism or autistic spectrum disorders, borderline personality disorder, antisocial personality disorder, body dysmorphic disorder, hoarding disorder (symptoms of hoarding disorder as part of the OCD diagnosis are allowed, but a primary diagnosis of hoarding disorder is excluded); a current diagnosis of Tourette’s disorder is also excluded;
4.Any eating disorder within the last 12 months;
5.Primary active major depressive episode or primary active anxiety disorder within the past 6 months.
6.Acute suicidality or suicide attempt or self-injurious behavior in the last 12 months.
7.Any positive (yes) C-SSRS response to questions 1-5 in last 6 months at screening and/or Since the Last Visit (before dosing) at the baseline visit;
8.Total BABS score >17 at screening and baseline;
9.Subjects 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 screening;
10.History of psychosurgery, Deep Brain Stimulation (DBS) or Electroconvulsive Therapy (ECT).
11.History of substance use disorder (drug or alcohol) in the last 12 months, with the exception of tobacco, as defined by DSM-5 criteria;
12.Positive urine drug screening for cannabis (both medical and recreational use of cannabis are prohibited; subjects will be expected to refrain from use during the period of the study), amphetamines (including MDMA/ecstasy), cocaine, barbiturate, PCP, and/or opiates at screening.
13. Women who are pregnant or breastfeeding

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the study is to evaluate the efficacy of troriluzole as adjunctive therapy compared to placebo in subjects with OCD who have had an inadequate response to their current OCD treatment based on the change in their Y-BOCS score;Secondary Objective: •To assess the safety and tolerability of troriluzole, relative to placebo, in subjects with OCD<br>•Evaluate the efficacy of troriluzole compared to placebo on functional disability as measured by the Sheehan Disability Scale (SDS)<br>•Evaluate the efficacy of troriluzole compared to placebo on global clinical condition as measured by the Clinical Global Impression- Severity Scale (CGI-S);Primary end point(s): Improvement in obsessive-compulsive symptomatology is assessed using the Y-BOCS change from baseline in the total score;Timepoint(s) of evaluation of this end point: Screening, Baseline, Week 4, Week 8 and Week 10

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The change from baseline on the SDS total score and the CGI Severity score;Timepoint(s) of evaluation of this end point: Screening, Baseline, Week 4, Week 8 and Week 10

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