ong-term Safety Study of Adjunctive Troriluzole in Subjects with Obsessive Compulsive Disorder

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: EUCTR2020-004654-30-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: 1200

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
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 1080
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 120

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)
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
b.A positive urine drug screen for cannabis is not necessarily exclusionary, however, cannabis use, both medical and recreational, is strongly discouraged. A positive urine drug screen for amphetamines (including MDMA/ecstasy), cocaine, barbiturate, PCP, and/or opiates at study entry is exclusionary
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
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 study course
m.Women who are pregnant or breastfeeding
3. Physical and Laboratory Test Findings
a.Uncontrolled hypertension at study entry(e.g.,repeated diastolic measurements = 96mmHg)
b.Hepatic test abnormalities at study entry(last visit of BHV4157-302/BHV4157-303):i.Aspartate Aminotransferase, Alanine Aminotransferase or GGT > 3 times upper limit of normal or ii.Total bilirubin > 2 ti

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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 desvenlafaxine treatment;Secondary Objective: None;Primary end point(s): Safety and tolerability are assessed using the frequency of unique subjects with: SAE; AEs leading to discontinuation; AEs judged to be related to study medication; and clinically significant laboratory abnormalities that are observed from baseline to week 48.;Timepoint(s) of evaluation of this end point: week 48

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): none;Timepoint(s) of evaluation of this end point: not applicable

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