A research study investigating troriluzole as a possible treatment for Obsessive Compulsive Disorder

Phase 3

Completed

• Conditions: Obsessive Compulsive Disorder

• Registration Number: 2024-514585-39-00
• Lead Sponsor: Biohaven Pharmaceuticals Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-07-30
• Last Update Posted: 2025-01-29

Recruitment & Eligibility

• Status: Ended
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

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.

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.

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.

Exclusion Criteria

Subjects with a history of more than two (2) previous failed or inadequate treatment trials of SSRIs, clomipramine, venlafaxine, or desvenlafaxine, (not including the current SSRI trial) given for an adequate duration at an adequate dose.

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.

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in obsessive-compulsive symptomatology is assessed using the Y-BOCS change from baseline in the total score.		Improvement in obsessive-compulsive symptomatology is assessed using the Y-BOCS change from baseline in the total score.

Secondary Outcome Measures

Name	Time	Method
The change from baseline on the SDS total score and the CGI Severity score.		The change from baseline on the SDS total score and the CGI Severity score.

Trial Locations

Locations (9)

Azienda Ospedaliera Universitaria Federico II Di Napoli; 🇮🇹 Naples, Italy

Azienda Ospedaliero-Universitaria San Luigi Gonzaga; 🇮🇹 Orbassano, Italy

ASST Fatebenefratelli Sacco; 🇮🇹 Milan, Italy

Ospedale San Raffaele S.r.l.; 🇮🇹 Milan, Italy

Bellvitge University Hospital; 🇪🇸 L'Hospitalet De Llobregat, Spain

Hospital Universitario Ramon Y Cajal; 🇪🇸 Madrid, Spain

Hospital Alvaro Cunqueiro; 🇪🇸 Vigo, Spain

Hospital Universitario Central De Asturias; 🇪🇸 Oviedo, Spain

Hospital Universitario De Salamanca; 🇪🇸 Salamanca, Spain

Azienda Ospedaliera Universitaria Federico II Di Napoli

🇮🇹Naples, Italy

Dr Andrea de Bartolomeis

Site contact

393478992595

adebarto@unina.it