Clinical Trials Register

Summary
EudraCT Number:	2020-004653-69
Sponsor's Protocol Code Number:	BHV4157-303
National Competent Authority:	Netherlands - Competent Authority
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2021-06-01
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Netherlands - Competent Authority

A.2

EudraCT number

2020-004653-69

A.3

Full title of the trial

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

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A research study investigating troriluzole (BHV-4157) as a possible treatment for Obsessive Compulsive Disorder (OCD)

Een wetenschappelijk onderzoek om troriluzole als een mogelijke behandeling van obsessief-compulsieve stoornis te bestuderen

A.3.2

Name or abbreviated title of the trial where available

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

Een wetenschappelijk onderzoek om troriluzole als een mogelijke behandeling van obsessief-compulsiev

A.4.1

Sponsor's protocol code number

BHV4157-303

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT04693351

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Biohaven Pharmaceuticals, Inc
B.1.3.4	Country	United States
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Biohaven Pharmaceuticals, Inc.
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Accelsiors CRO and Consultancy Services Ltd.
B.5.2	Functional name of contact point	Regulatory Unit
B.5.3	Address:
B.5.3.1	Street Address	103 Haros Str.
B.5.3.2	Town/ city	Budapest
B.5.3.3	Post code	1222
B.5.3.4	Country	Hungary
B.5.4	Telephone number	+361299 00 91
B.5.5	Fax number	+361299 00 96
B.5.6	E-mail	regulatory@accelsiors.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Troriluzole
D.3.2	Product code	BHV-4157
D.3.4	Pharmaceutical form	Capsule
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Troriluzole
D.3.9.1	CAS number	1926204-76-3
D.3.9.2	Current sponsor code	BHV-4157
D.3.9.3	Other descriptive name	Troriluzole
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Troriluzole
D.3.2	Product code	BHV-4157
D.3.4	Pharmaceutical form	Capsule
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Troriluzole
D.3.9.1	CAS number	1926204-76-3
D.3.9.2	Current sponsor code	BHV-4157
D.3.9.3	Other descriptive name	Troriluzole
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	140
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Capsule
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Obsessive Compulsive Disorder

E.1.1.1

Medical condition in easily understood language

Obsessive Compulsive Disorder (OCD)

E.1.1.2

Therapeutic area

Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10002860
E.1.2	Term	Anxiety disorder NEC
E.1.2	System Organ Class	100000004873

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

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

E.2.2

Secondary objectives of the trial

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

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

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
4.Subjects must be on stable doses of other psychotropic medication (with exclusions specified below) for at least 12 weeks prior to screening;
5.CGI-S score of ≥ 4 at screening and baseline;
6.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 postmenopausal) must agree to use highly effective birth control, including two methods of contraception, for the duration of the study (i.e., beginning 30 days prior to Baseline and extending to 30 days for women and 90 days for men after the last dose of study drug). The two methods of contraception should include:
i.One barrier method (e.g. diaphragm with spermicide, condom with spermicidal gel, 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
7.WOCBP must have a negative serum pregnancy test at screening and a negative urine pregnancy test within
approximately 24 hours prior to dosing at Baseline
8.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).

E.4

Principal exclusion criteria

1.Subjects with a history of more than two (2) previous failed or inadequate treatment classes SSRIs, clomipramine, venlafaxine, or desvenlafaxine, given for an adequate duration at an adequate dose as defined by the criteria taken from the MGH-TRQ-OCD .
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;
4.Any eating disorder within the last 12 months;
5.Primary active major depressive episode or primary active anxiety disorder within the past 6 months.
6.Acute suicidality or suicide attempt or self-injurious behavior in the last 12 months.
7.Any positive ("yes") C-SSRS response to questions 1-5 in last 6 months at screening and/or Since the Last Visit (before dosing) at the baseline visit;
8.Total BABS score >17 at screening and baseline;
9.Subjects who may have received a non-biological investigational agent in any clinical trial within 30 days or a biological agent within 90 days prior to screening;
10.History of psychosurgery, Deep Brain Stimulation (DBS) or Electroconvulsive Therapy (ECT).
11.History of substance use disorder (drug or alcohol) in the last 12 months, with the exception of tobacco, as defined by DSM-5 criteria;
12.Positive urine drug screening for cannabis (both medical and recreational use of cannabis are prohibited; subjects will be expected to refrain from use during the period of the study), amphetamines (including MDMA/ecstasy), cocaine, barbiturate, PCP, and/or opiates at screening.
13. Women who are pregnant or breastfeeding

E.5 End points

E.5.1

Primary end point(s)

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

E.5.1.1

Timepoint(s) of evaluation of this end point

Screening, Baseline, Week 4, Week 8 and Week 10

E.5.2

Secondary end point(s)

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

E.5.2.1

Timepoint(s) of evaluation of this end point

Screening, Baseline, Week 4, Week 8 and Week 10

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

E.6.10

Pharmacogenetic

Yes

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

multicenter

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Canada

China

United States

Netherlands

Spain

Italy

United Kingdom

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

Last subject last visit

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

600

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

100

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

140

F.4.2.2

In the whole clinical trial

700

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

Subjects will return to previous standard of care treatment.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2021-06-01

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-09-27

P. End of Trial
P.	End of Trial Status	Ongoing

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