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

2024-514585-39-00 Protocol BHV4157-303 Therapeutic confirmatory (Phase III) Ended

Start 12 Jul 2021 · End 29 Apr 2025 · Status Ended · 2 EU/EEA countries · 9 sites · Protocol BHV4157-303

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)
Status Ended
Participants planned 700
Countries 2
Sites 9

Obsessive Compulsive Disorder

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.

Key facts

Sponsor
Biohaven Pharmaceuticals Inc.
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04]
Trial duration
12 Jul 2021 → 29 Apr 2025
Decision date (initial)
2024-07-30
Transition trial
Yes
Low-intervention
No
Rare-disease indication
No
Vulnerable population
Yes

External identifiers

EU CT number
2024-514585-39-00
EudraCT number
2020-004653-69
ClinicalTrials.gov
NCT04693351

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacokinetic, Efficacy, Dose response, Pharmacogenetic, Therapy

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 objectives 3

  1. To assess the safety and tolerability of troriluzole, relative to placebo, in subjects with OCD.
  2. Evaluate the efficacy of troriluzole compared to placebo on functional disability as measured by the Sheehan Disability Scale (SDS).
  3. Evaluate the efficacy of troriluzole compared to placebo on global clinical condition as measured by the Clinical Global Impression- Severity Scale (CGI-S).

Conditions and MedDRA coding

Obsessive Compulsive Disorder

VersionLevelCodeTermSystem organ class
20.0 LLT 10002860 Anxiety disorder NEC 10037175

Regulatory references

Plan to share IPD
No
EU CT numberTitleSponsor
2020-004654-30 A Multicenter, 48-week Open-Label Safety Study of Adjunctive Troriluzole in Subjects with Obsessive Compulsive Disorder, Ensayo de seguridad de diseño abierto, multicéntrico, de troriluzol como tratamiento complementario durante 48 semanas en pacientes con trastorno obsesivo-compulsivo., Ensayo de seguridad en fase abierta, multicéntrico, a largo plazo, para evaluar el Troriluzol como tratamiento complementario en pacientes con Trastorno Obsesivo-Compulsivo, Een multicentrische, open-label veiligheidsstudie van 48 weken aanvullende behandeling met troriluzole van proefpersonen met obsessief-compulsieve stoornis, Een multicenter, lange termijn open-label veiligheidsonderzoek naar adjuvante troriluzol bij proefpersonen met obsessieve compulsieve stoornis, Een multicenter, lange termijn open-label veiligheidsonderzoek naar adjuvante troriluzol bij proefpersonen met obsessieve compulsieve stoornis, Een multicenter, lange termijn open-label veiligheidsonderzoek naar adjuvante troriluzol bij proefpersonen met obsessieve compulsieve stoornis, Een multicentrische, open-label veiligheidsstudie van 48 weken aanvullende behandeling met troriluzole van proefpersonen met obsessief-compulsieve stoornis, Studio multricentrico in aperto, di 48 settimane, volto a valutare la sicurezza di Troriluzolo come adiuvante in soggetti con disturbo ossessivo compulsivo

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

  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.

Exclusion criteria 3

  1. 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.
  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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

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

Secondary endpoints 1

  1. The change from baseline on the SDS total score and the CGI Severity score.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Troriluzole

PRD8836296 · Product

Active substance
Troriluzole
Pharmaceutical form
CAPSULE
Route of administration
ORAL
Max daily dose
140 mg milligram(s)
Max total dose
280 mg milligram(s)
Max treatment duration
10 Week(s)
Authorisation status
Not Authorised
MA holder
BIOHAVEN PHARMACEUTICALS, INC
Paediatric formulation
No
Orphan designation
No

Troriluzole

PRD8836295 · Product

Active substance
Troriluzole
Pharmaceutical form
CAPSULE
Route of administration
ORAL
Max daily dose
100 mg milligram(s)
Max total dose
200 mg milligram(s)
Max treatment duration
10 Week(s)
Authorisation status
Not Authorised
MA holder
BIOHAVEN PHARMACEUTICALS, INC
Paediatric formulation
No
Orphan designation
No

Placebo 1

Placebo for BHV-4157 capsules, 100mg, 140mg

N/A · Product

Other product name
N/A
Pharmaceutical form
N/A
ATC code
N/A — N/A
Marketing authorisation
N/A
MA holder
N/A
MA country
Iceland
Paediatric formulation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Biohaven Pharmaceuticals Inc.

3 Total trials 3 Ended
Commercial
Sponsor organisation
Biohaven Pharmaceuticals Inc.
Address
215 Church Street
City
New Haven
Postcode
06510-1803
Country
United States

Scientific contact point

Organisation
Biohaven Pharmaceuticals Inc.
Contact name
Clinical Trial Lead

Public contact point

Organisation
Biohaven Pharmaceuticals Inc.
Contact name
Chief Compliance Officer

Third parties 7

OrganisationCity, countryDuties
4g Clinical LLC
ORG-100042775
 Wellesley, United States Interactive response technologies (IRT)
Rho Inc.
ORG-100048371
 Durham, United States Code 10, Data management
Eresearchtechnology Inc.
ORG-100013039
 Philadelphia, United States Code 13
Accelsiors Kft.
ORG-100011457
 Budapest XXII, Hungary On site monitoring, Code 12, Other
Acm Medical Laboratory Inc.
ORG-100042792
 Rochester, United States Other, Laboratory analysis
PPD Development LP
ORG-100011560
 Wilmington, United States Code 8
Syneos Health Clinique Inc.
ORG-100028348
 Quebec, Canada Other

Locations

2 EU/EEA countries · 9 investigational sites

By country

CountryMS statusPlanned subjectsSites
Italy Ended 50 4
Spain Ended 50 5
Rest of world
United Kingdom, United States, China, Canada
 — 600 —

Investigational sites

Italy

4 sites · Ended
ASST Fatebenefratelli Sacco
Department of Biomedical and Clinical Sciences “L. Sacco”, Via Giovanni Battista Grassi 74, 20157, Milan
Azienda Ospedaliera Universitaria Federico II Di Napoli
Laboratory of Molecular Psychiatry at Department of Neuroscience, Via Sergio Pansini 5, 80131, Naples
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Department of Neurosciences, Regione Gonzole 10, 10043, Orbassano
Ospedale San Raffaele S.r.l.
Mood Disorder Unit, Via Stamira D'ancona 20, 20127, Milan

Spain

5 sites · Ended
Hospital Alvaro Cunqueiro
Department of Psychiatry, Estrada Clara Campoamor No 341, 36312, Vigo
Hospital Universitario Central De Asturias
Department of Psychiatry, Avenida De Roma S/n, 33011, Oviedo
Bellvitge University Hospital
Department of Psychiatry, Carrer De La Feixa Llarga S/N, 08907, L'Hospitalet De Llobregat
Hospital Universitario De Salamanca
Department of Psychiatry, Paseo De San Vicente 58-182, 37007, Salamanca
Hospital Universitario Ramon Y Cajal
Department of Psychiatry and Psychology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Italy 2021-12-13 2022-01-03 2024-09-20
Spain 2021-07-12 2025-01-11 2022-03-23 2025-01-10

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

TitleSubmission dateStatusType
BHV4157-303 Summary of Results
SUM-131545
 2026-04-29T22:47:30 Submitted Summary of Results

Layperson summary Annex V

TitleSubmission dateStatusType
BHV4157-303 Lay Summary of Results 2026-04-29T22:47:38 Submitted Laypersons Summary of Results

Documents 27 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Laypersons summary of results (for publication) BHV4157-303_Plain Language Results Summary_Apr 2026 1
Protocol (for publication) D1_Protocol_2024-514585-39_FOR PUBLICATION v3.1 Am2
Protocol (for publication) D4_Patient facing documents_CGI-S Scale_FOR PUBLICATION 1
Protocol (for publication) D4_Patient facing documents_CGI-S Scale_FOR PUBLICATION_ES 15
Protocol (for publication) D4_Patient facing documents_CGI-S Scale_FOR PUBLICATION_IT 15
Protocol (for publication) D4_Patient facing documents_Sheehan Disability Scale_SDS_FOR PUBLICATION N/A
Protocol (for publication) D4_Patient facing documents_Sheehan Disability Scale_SDS_FOR PUBLICATION_ES 3
Protocol (for publication) D4_Patient facing documents_Sheehan Disability Scale_SDS_FOR PUBLICATION_IT 3
Protocol (for publication) D4_Patient facing documents_Y-BOCS Scale_FOR PUBLICATION 1
Protocol (for publication) D4_Patient facing documents_Y-BOCS Scale_FOR PUBLICATION_ES 1
Protocol (for publication) D4_Patient facing documents_Y-BOCS Scale_FOR PUBLICATION_IT 1
Recruitment arrangements (for publication) K2_Recruitment material_Flyer_ES N/A
Recruitment arrangements (for publication) K2_Recruitment material_Screenshots of the site Home page_ES N/A
Recruitment arrangements (for publication) K2_Recruitment material_Screenshots of the site_About_ES N/A
Recruitment arrangements (for publication) K2_Recruitment material_Screenshots of the site_FAQ_ES N/A
Recruitment arrangements (for publication) K2_Recruitment material_Screenshots of the site_Qualification_ES N/A
Recruitment arrangements (for publication) K2_Recruitment material_Web site cookie policy N/A
Recruitment arrangements (for publication) K2_Recruitment material_Web site privacy policy N/A
Recruitment arrangements (for publication) K2_Recruitment material_Web site Terms and Conditions N/A
Subject information and informed consent form (for publication) L1_SIS and ICF_FOR PUBLICATION 5.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Pharmacogentic_FOR PUBLICATION 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Pregnant partner_FOR PUBLICATION 2.0
Summary of Product Characteristics (SmPC) (for publication) Statement for minimum required documents N/A
Summary of results (for publication) BHV4157-303_EUCTIS Results Summary_Apr2026 1
Synopsis of the protocol (for publication) D1_Protocol synopsis_EN_2024-514585-39_FOR PUBLICATION 1.0
Synopsis of the protocol (for publication) D1_Protocol synopsis_ES_2024-514585-39_FOR PUBLICATION 1.0
Synopsis of the protocol (for publication) D1_Protocol synopsis_IT_2024-514585-39_FOR PUBLICATION 2

Application history

3 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-06-14 Italy Acceptable
2024-07-25
 2024-07-30
2 NON SUBSTANTIAL MODIFICATION NSM-1 2024-08-23 Italy Acceptable
2024-07-25
 2024-08-23
3 SUBSTANTIAL MODIFICATION SM-1 2024-10-22 Acceptable
2025-01-28
 2025-01-29

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