A Randomized, Double-Blind, Placebo-Controlled Trial of Adjunctive Troriluzole in Obsessive Compulsive Disorder

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • sponsor
    Biohaven Pharmaceuticals, Inc.
Updated on 5 April 2021

Summary

This research study is investigating troriluzole (BHV-4157) as a possible treatment for obsessive compulsive disorder (OCD) compared to placebo. Up to 60% of patients with OCD do not have adequate response to approved oral treatments. Troriluzole is an "investigational" or experimental drug, which means that the drug has not been approved by regulatory authorities for use outside of research studies.

Troriluzole is thought to work like its main by-product riluzole which has been FDA approved for ALS treatment and tends to block certain mechanisms in the body that cause obsessions and compulsions. The study drug also has better oral bioavailability, no food restrictions, lower overall burden to the liver, reduced pharmacokinetic variability, and only has to be dosed once daily compared to riluzole.

Approximately, 700 participants will receive the study drug or placebo. Participation in this study will last about 18 weeks which includes at least 7 office visits at the study center. Biohaven is also sponsoring a 48-week open-label extension available for those who complete the double-blind portion.

Description

Sponsor: Biohaven Pharmaceuticals, Inc.
Indication: Obsessive Compulsive Disorder
Study Drug: Troriluzole (BHV-4157)
Study Phase: 3

  • Screening phase – up to 42 days – 1 visit, 1 SAFER call
  • Double-blind treatment phase – 10 weeks – 5 visits
  • Post-dose follow up – 2 weeks – 1 visit
50% BHV-4157 280mg + SSRI - 50% placebo + SSRI

Details
Condition Obsessive-Compulsive Disorder
Clinical Study IdentifierTX270521
SponsorBiohaven Pharmaceuticals, Inc.
Last Modified on5 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 65 yrs?
Gender: Male or Female
Do you have any of these conditions: Do you have Obsessive-Compulsive Disorder??
Males or females 18 to 65 with OCD symptoms for at least 1 year
BMI <40 kg/m2
Must be currently experiencing a non-response, minimal response, or no meaningful clinical benefit to an SSRI, clomipramine, venlafaxine, desvenlafaxine monotherapy treatment for at least 8 weeks at screening and 10 weeks at Baseline
Citalopram (Celexa) 20-40mg (20mg max for subjects over 60 or with hepatic impairment)
Escitalopram (Lexapro) 10-20mg
Fluoxetine (Prozac) 20-60mg
Fluvoxamine (Luvox) 100-300mg
Paroxetine (Paxil) 40-60mg
Sertraline (Zoloft) 50-200mg
Clomipramine (Anafranil) 100-250mg
Venlafaxine (Effexor XR) 75-225mg
Desvenlafaxine (Pristiq) 50mg - the protocol states that higher doses are allowed if stable and well tolerated
Must be on stable doses of other psychotropic medications for at least 12 weeks prior to screening

Exclusion Criteria

A history of more than 2 previous failed treatments of SSRIs, clomipramine, venlafaxine, desvenlafaxine (not including the current) at adequate dose (see table above) and for a duration of at least 12 weeks
Current or prior history of bipolar I or II disorder, schizophrenia or other psychotic disorders, schizoaffective disorder, autism or autistic disorders, borderline personality disorder, antisocial personality disorder, body dysmorphia, hoarding disorder (as part of OCD symptoms is ok) and a current diagnosis of Tourette’s
Any eating disorder within the last 12 months
Primary active MDE or anxiety disorder within the past 6 months (subjects on a stable dose of a non-tricyclic, non-MAOI ADT may be eligible if the dose has been stable for 3 months prior to Baseline and no changes are expected)
Acute suicidality, suicide attempt, or self-injurious behavior in the last 12 months
History of psychosurgery, DBS, ECT, or TMS (within 3 months of screening)
History of substance use disorder in the last 12 months, with the exception of tobacco
Clinical history of stroke, seizure disorder, traumatic brain injury with ongoing sequelae
Subjects with a history of Type I or Type II insulin-dependent diabetes mellitus (IDDM)
Hematologic or solid malignancy diagnosis within 5 years prior to screening
Any unstable cardiovascular (includes uncontrolled hypertension of repeated diastolic ≥ 96 mmHg), pulmonary, gastrointestinal, or hepatic disease 30 days prior to screening
Immunocompromised subjects. Note: Subjects taking a systemic immunosuppressive agent may be randomized only if they are on a stable dose, have no clinically relevant immunosuppression, and have a white blood count (WBC) within normal limits
A history of any gastrointestinal surgery that impacts the absorption of study drug
Positive for HIV, Hep B, or Hep C
Behavioral therapy (cognitive behavioral therapy or exposure response prevention therapy) for OCD that has been initiated within 3 months prior to screening
Previous treatment with riluzole
Previous participation in a study with troriluzole (screen-failed subjects from BHVN4157- 202 may be considered for this trial with approval from the medical monitor)
Has received an investigational agent in any clinical trial within 30 days or a biological agent within 90 days
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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