Clinical Trials Register

Summary
EudraCT Number:	2020-004653-69
Sponsor's Protocol Code Number:	BHV4157-303
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2021-06-07
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

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

Sperimentazione randomizzata, in doppio cieco, controllata con placebo, di troriluzolo aggiuntivo nel disturbo ossessivo compulsivo

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)

Studio di ricerca che indaga il troriluzolo (BHV-4157) come possibile trattamento per il disturbo ossessivo compulsivo (DOC)

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

Studio diricerca che indaga troriluzolo come possibile trattamento per disturbo ossessivo compulsivo

A.4.1

Sponsor's protocol code number

BHV4157-303

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	+3612990091
B.5.5	Fax number	+3612990096
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.2.1.2	Country which granted the Marketing Authorisation	Italy
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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.3.9.4	EV Substance Code	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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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

Disordine Ossessivo Compulsivo

E.1.1.1

Medical condition in easily understood language

Obsessive Compulsive Disorder (OCD)

Disordine Ossessivo Compulsivo (DOC)

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

L’obiettivo primario dello studio è valutare l’efficacia del troriluzolo come terapia aggiuntiva rispetto al placebo, in soggetti con DOC che hanno avuto una risposta inadeguata al loro attuale trattamento per la DOC, basato sul cambiamento nel loro punteggio Y-BOCS

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)

•Valutare la sicurezza e la tollerabilità di troriluzolo, rispetto al placebo, in soggetti con DOC
•Valutare l’efficacia di troriluzolo rispetto a placebo sulla disabilità funzionale come misurato dalla scala di disabilità di Sheehan (SDS)
•Valutare l’efficacia del troriluzolo rispetto a placebo sulle condizioni cliniche globali come misurata dalla scala clinica globale di impressione – gravità (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).

1.Diagnosi primaria di DOC secondo il manuale diagnostico e statistico dei disturbi mentali, Quinta edizione come confermato dal MINI allo screening; La durata della malattia del soggetto deve essere di = 1 anno;
2.I soggetti devono attualmente manifestare una mancata risposta o una risposta inadeguata al loro attuale farmaco SOC definito come: il punteggio totale Y-BOCS dei soggetti deve essere = 22 allo screening e al basale, riflettendo sintomi DOC moderati o gravi.
3.I soggetti devono attualmente assumere un SSRI (ad eccezione della fluvoxamina, cfr. sezione 1.1.3), o un trattamento in monoterapia con clomipramina, venlafaxina o desvenlafaxina per una durata adeguata e ad una dose adeguata definita come dal protocollo di sperimentazione clinica
4.I soggetti devono assumere dosi stabili di altri farmaci psicotropi (con esclusioni specificate di seguito) per almeno 12 settimane prima dello screening;
5. Punteggio CGI-S di = 4 allo screening e al basale;
6. Le donne e gli uomini fertili (inclusi coloro che hanno subito una vasectomia meno di sei mesi fa) con partner donne che sono fertili (cioè che non si sono sottoposte alla procedura di occlusione bilaterale delle tube e non sono in menopausa) devono accettare di usare alti metodi contraccettivi, inclusi due metodi di contraccezione, per tutta la durata dello studio (cioè a partire da 30 giorni prima della visita basale e fino a 30 giorni, per le donne, e 90 giorni per gli uomini, dopo l’ultima dose di farmaco). I due metodi di contraccezione dovrebbero includere:
i. Metodo ad una barriera (ad esempio il diaframma con spermicida, preservativo con gel spermicida, cappuccio cervicale);
ii. Un altro metodo che potrebbe includere contraccettivi ormonali (ad esempio combinazione contenente estrogeni e progesterone, o progesterone solo con dose di somministrazione orale, vaginale, iniettabile o transdermica), dispositivo intrauterino, sistema di rilascio ormonale intrauterino usato per almeno 4 settimane prima del rapporto sessuale.
7. Le donne fertili devono avere un test di gravidanza su siero negativo allo screening e un test di gravidanza negativo su urine entro circa 24 ore prima del dosaggio al basale.
8. E’ richiesto che gli uomini che sono sessualmente attivi e che hanno una relazione con donne fertili, accettino di utilizzare due metodi contraccettivi per tutta la durata dello studio (a partire dal primo trattamento e fino a 90 giorni dopo l'ultima dose di farmaco di studio).

E.4

Principal exclusion criteria

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;
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 (before dosing) baseline
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.Subjects with known hypersensitivity to riluzole, placebo or any of the excipients.
14. Women who are pregnant or breastfeeding

1.Soggetti con una storia di più di due (2) precedenti trattamenti falliti o inadeguati di SSRI, clomipramina, venlafaxina o desvenlafaxina (non è incluso l'attuale studio SSRI) somministrati per una durata adeguata e ad una dose adeguata.
2.I soggetti dovrebbero essere esclusi, allo screening o al basale, se qualsiasi condizione medica o psichiatrica diversa dalla DOC, come specificato nei criteri di inclusione, potrebbe spiegare o contribuire in modo significativo ai sintomi dei soggetti o che potrebbe confondere la valutazione dei sintomi della DOC;
3.Storia attuale o precedente, secondo i criteri DSM-5, di disturbo bipolare I o II, schizofrenia o altri disturbi psicotici, disturbo schizoaffettivo, autismo o disturbi dello spettro autistico, disturbo borderline della personalità, disturbo antisociale della personalità, disturbo dismorfico del corpo, disturbo da accumulazione (sono consentiti sintomi di disturbo da accumulazione come parte della diagnosi della DOC, ma è esclusa una diagnosi primaria di disturbo da accumulazione); è esclusa anche una diagnosi attuale del disturbo di Tourette;
4.Qualsiasi disturbo alimentare negli ultimi 12 mesi;
5.Episodio primario depressivo maggiore attivo o disturbo primario d'ansia attivo negli ultimi 6 mesi.
6.Tendenza al suicidio acuto o tentativo di suicidio o comportamento autolesivo negli ultimi 12 mesi.
7.Qualsiasi risposta C-SSRS positiva ("sì") alle domande 1-5 negli ultimi 6 mesi allo screening e/o (prima del dosaggio) al basale
8.Punteggio totale BABS >17 allo screening e al basale;
9.Soggetti che potrebbero aver ricevuto un agente investigativo non biologico in qualsiasi studio clinico entro 30 giorni o un agente biologico entro 90 giorni prima dello screening;
10.Storia di psicochirurgia, di stimolazione cerebrale profonda (SCP) o di terapia elettroconvulsiva (TEC).
11.Storia di disturbo da uso di sostanze (droga o alcol) negli ultimi 12 mesi, ad eccezione del tabacco, come definito dai criteri DSM-5;
12.Test positivo delle urine per la cannabis allo screening (è vietato sia l'uso medico e ricreativo della cannabis; ci si aspetta che i soggetti si astengano dall'uso durante il periodo dello studio), anfetamine (tra cui MDMA/ecstasy), cocaina, barbiturici, PCP e/o oppiacei allo Screening.
13. Soggetti con ipersensibilità nota al riluzolo, placebo o qualsiasi altro eccipiente
14. Le donne incinta o che stanno allattando

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

Il miglioramento nella sintomatologia ossessivo-compulsiva viene valutato utilizzando la variazione Y-BOCS rispetto al basale del punteggio totale

E.5.1.1

Timepoint(s) of evaluation of this end point

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

Screening, basale, settimana 4, settimana 8 e settimana 10

E.5.2

Secondary end point(s)

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

Il cambiamento rispetto al basale del punteggio totale SDS e del punteggio di gravità CGI

E.5.2.1

Timepoint(s) of evaluation of this end point

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

Screening, basale, settimana 4, settimana 8 e settimana 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

multicentrico

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

Information not present in EudraCT

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

United States

Italy

Netherlands

Spain

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

Ultimo paziente ultima visita

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.

I soggetti torneranno al trattamento standard precedente.

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

2021-11-03

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-09-09

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

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials