Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ended
Participants planned
1,200
Countries
2
Sites
9
Obsessive Compulsive Disorder
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.
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
- 16 Mar 2022 → 14 Feb 2026
- Decision date (initial)
- 2024-07-02
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Biohaven Pharmaceuticals, Inc.
External identifiers
- EU CT number
- 2024-512108-20-00
- EudraCT number
- 2020-004654-30
- ClinicalTrials.gov
- NCT04708834
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Dose response, Therapy, Safety
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.
Conditions and MedDRA coding
Obsessive Compulsive Disorder
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10002860 | Anxiety disorder NEC | 10037175 |
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2020-004653-69 | A Randomized, Double-Blind, Placebo-Controlled Trial of Adjunctive Troriluzole in Obsessive Compulsive Disorder, Een gerandomiseerd, dubbelblind, placebogecontroleerd onderzoek naar troriluzole als aanvulling bij behandeling van obsessief-compulsieve stoornis, Een gerandomiseerd, dubbelblind, placebogecontroleerd onderzoek naar troriluzole als aanvulling bij behandeling van obsessief-compulsieve stoornis, Een gerandomiseerd, dubbelblind, placebogecontroleerd onderzoek naar troriluzole als aanvulling bij behandeling van obsessief-compulsieve stoornis, Sperimentazione randomizzata, in doppio cieco, controllata con placebo, di troriluzolo aggiuntivo nel disturbo ossessivo compulsivo, Sperimentazione randomizzata, in doppio cieco, controllata con placebo, di troriluzolo aggiuntivo nel disturbo ossessivo compulsivo, Ensayo Aleatorizado, Doble Ciego y Controlado con Placebo de Troriluzol como Tratamiento Complementario en el Trastorno Obsesivo-Compulsivo |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- 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.
- Determined by the investigator to be medically stable at the final visit of BHV4157-302 or BHV4157-303, (the labs collected at the Week 10 visit for BHV4157-302 or BHV4157-303), as assessed by medical history, physical examination, laboratory test results, and electrocardiogram testing.
- 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.
Exclusion criteria 3
- Subjects who did not successfully complete randomization phase in BHV4157-302/BHV4157-303 study.
- Acute suicidality or suicide attempt or self injurious behavior in last 12 months.
- Patients who plan to receive non-biological or biological investigational agent in while enrolled in trial.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 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 over the course of treatment.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD8836295 · 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
- 144 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- BIOHAVEN PHARMACEUTICALS, INC
- Paediatric formulation
- No
- Orphan designation
- No
PRD8836296 · 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
- 144 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- BIOHAVEN PHARMACEUTICALS, INC
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Biohaven Pharmaceuticals Inc.
- 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 6
| Organisation | City, country | Duties |
|---|---|---|
| Eresearchtechnology Inc. ORG-100013039
|
Philadelphia, United States | Code 13 |
| PPD Development LP ORG-100011560
|
Wilmington, United States | Code 8 |
| 4g Clinical LLC ORG-100042775
|
Wellesley, United States | Interactive response technologies (IRT) |
| Rho Inc. ORG-100048371
|
Durham, United States | Code 10, Data management |
| Acm Medical Laboratory Inc. ORG-100042792
|
Rochester, United States | Other, Laboratory analysis |
| Accelsiors Kft. ORG-100011457
|
Budapest XXII, Hungary | On site monitoring, Code 12, Other, Code 8 |
Locations
2 EU/EEA countries · 9 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ended | 25 | 4 |
| Spain | Ended | 18 | 5 |
| Rest of world
United States, Canada, United Kingdom
|
— | 1,157 | — |
Investigational sites
ASST Fatebenefratelli Sacco
Department of Biomedical and Clinical Sciences “L. Sacco”, Via Giovanni Battista Grassi 74, 20157, Milan
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Department of Neurosciences, Regione Gonzole 10, 10043, Orbassano
Azienda Ospedaliera Universitaria Federico II Di Napoli
Laboratory of Molecular Psychiatry at Department of Neuroscience, Via Sergio Pansini 5, 80131, Naples
Ospedale San Raffaele S.r.l.
Mood Disorder Unit, Via Stamira D'ancona 20, 20127, Milan
Hospital Universitario Central De Asturias
Department of Psychiatry, Avenida De Roma S/n, 33011, Oviedo
Hospital Universitario Ramon Y Cajal
Department of Psychiatry and Psychology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Alvaro Cunqueiro
Department of Psychiatry, Estrada Clara Campoamor No 341, 36312, Vigo
Hospital Universitario De Salamanca
Department of Psychiatry, Paseo De San Vicente 58-182, 37007, Salamanca
Bellvitge University Hospital
Department of Psychiatry, Carrer De La Feixa Llarga S/n, 08907, L'hospitalet De Llobregat
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Italy | 2022-03-16 | 2022-03-16 | 2024-09-20 | ||
| Spain | 2022-04-21 | 2022-06-03 | 2025-04-17 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 18 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol administrative letter_2024-512108-20_FOR PUBLICATION | 1.0 |
| Protocol (for publication) | D1_Protocol_2024-512108-20_FOR PUBLICATION | 6.0_EU |
| 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) | Statement for minimum required documents | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_FOR PUBLICATION | 9.0 |
| 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 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_EN_2024-512108-20_FOR PUBLICATION | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ES_2024-512108-20_FOR PUBLICATION | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_IT_2024-512108-20_FOR PUBLICATION | 3 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-06 | Italy | Acceptable 2024-06-27
|
2024-07-01 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-08-23 | Italy | Acceptable 2024-06-27
|
2024-08-23 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-10-28 | Acceptable 2025-01-23
|
2025-01-27 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-03-11 | Acceptable 2025-04-30
|
2025-05-06 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-09-09 | Acceptable 2025-10-21
|
2025-10-29 |