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

Phase 3

• Conditions: Obsessive Compulsive Disorder; OCD; 10037173

• Registration Number: NL-OMON52032
• Lead Sponsor: Biohaven Pharmaceuticals Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 8

Inclusion Criteria

1. Informed Consent:
a. Signed informed consent form prior to the initiation of any protocol
required procedures.
2. Age and Sex:
a. Male and female outpatient subjects between the ages of 18 - 65 upon entry
into BHV4157-302 or BHV4157-303.
3.Target Population:
a. 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.
b.Determined by the investigator to be medically stable at the final visit of
BHV4157-302 or BHV4157-303, as assessed by medical history, physical
examination, laboratory test results, and electrocardiogram
testing.
c. Minimum of 6 years of education or equivalent to complete necessary scales
and understand consent forms;
d. Subjects must have adequate hearing, vision, and language skills to perform
neuropsychiatric testing and interviews as specified in the protocol;
e. Subjects must be able to understand and agree to comply with the prescribed
dosage regimens and procedures; report for regularly scheduled office visits;
and reliably communicate with study personnel about AEs and concomitant
medications;
f. 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.
g. The two methods should include:
i. one barrier method (e.g. diaphragm with spermicide, condom with spermicidal
gel, intrauterine devices, 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 (Section 5.5);
h. Women of childbearing potential must have a negative serum pregnancy test
throughout the study
i. 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)
j. No clinically significant abnormality on the medical or laboratory
evaluation. A subject with a clinical abnormality or laboratory parameters
outside the reference range may be included only if the investigator considers
that the finding is not clinically significant and will not introduce
additional risk factors and will not interfere with the study procedure

Exclusion Criteria

1. Target Disease Exceptions
a.Subjects who did not successfully complete randomization phase in
BHV4157-302/BHV4157-303 study
b.Current or prior history 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
OCD diagnosis are allowed,but primary diagnosis of hoarding disorder is
excluded);current diagnosis of Tourette's disorder
c.Any eating disorder within last 12 months
d.Primary active major depressive episode or primary active anxiety disorder
within past 6 months
e.Acute suicidality or suicide attempt or self injurious behavior in last 12
months
f. Any positive Columbia Suicide Severity Rating Scale response to questions
1-5 at baseline(final visit of BHV4157-302/BHV4157-303) unless,after evaluation
of subject at Week 10 visit,investigator believes subject should continue in
study and that open-label treatment offers acceptable risk-benefit profile
g.Patients who plan to receive non-biological or biological investigational
agent in while enrolled in trial
h.History of psychosurgery,Deep Brain Stimulation or Electroconvulsive Therapy
2.Medical History Exclusions:
a.History of substance use disorder(drug or alcohol) in last 12 months,with
exception of tobacco,as defined by DSM-5 criteria
bPositive urine drug screening (UDS) for cannabis (both medical and
recreational use of cannabis are prohibited):, amphetamines (including
MDMA/ecstasy), cocaine, barbiturate, PCP, and/or opiates at study entry.
c.Prior or current general medical condition that may confound ability to
interpret safety and efficacy results as determined by Investigator
d.Clinical history of stroke,seizure disorder,traumatic brain injury with
ongoing sequelae
e.Patients with history of Type I or Type II insulin-dependent diabetes mellitus
f.Active liver disease or history of hepatic intolerance to medications that,in
investigator's judgment, is medically significant
g.Any unstable cardiovascular(includes uncontrolled
hypertension),pulmonary,gastrointestinal, or hepatic disease at study entry
h.End-stage cardiovascular disease(e.g.,Congestive Heart Failure New York Heart
Association Class III or IV or unstable angina)
i.History of chronic pulmonary disease or chronic pulmonary symptoms; well
controlled asthma is allowed per investigator's clinical judgement;
j.Immunocompromised subjects.Subjects taking systemic immunosuppressive agent
may be entered in trial only if they are on stable dose,have no clinically
relevant immunosuppression,and have white blood count within normal limits
k.History of medically significant gastrointestinal illnesses including:
i.Current diagnosis of active,peptic ulceration or gastrointestinal bleeding
and/orchronic inflammatory bowel disease at study entry;
ii.History of any gastrointestinal surgery that impacts absorption of study
drug;
iii.Chronic or frequent episodes of loose stools
l.History or evidence of any medical,neurological or psychological condition
that would expose subject to undue risk of significant AE or interfere with
assessments of safety and efficacy during course of trial
as determined by investigator's clinical

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Safety and tolerability are assessed using the frequency of unique subjects<br /><br>with: SAE; AEs leading to discontinuation; AEs judged to be related to study<br /><br>medication; and clinically significant laboratory abnormalities that are<br /><br>observed from baseline to week 48.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Not applicable</p><br>