Clinical Trials Register

Summary
EudraCT Number:	2021-005246-15
Sponsor's Protocol Code Number:	BHV3000-315
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:
Date on which this record was first entered in the EudraCT database:	2022-09-06
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2021-005246-15

A.3

Full title of the trial

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rimegepant in Migraine Prevention in Children and Adolescents = 6 to <18 years of age

Studio di fase 3, randomizzato, in doppio cieco, controllato con placebo per valutare l’efficacia e la sicurezza di rimegepant nella prevenzione dell’emicrania in bambini e adolescenti di età compresa tra =6 e <18 anni

A.3.1

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

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to study the Efficacy and Safety of Rimegepant in Migraine Prevention in Children and Adolescents = 6 to <18 years of age

Studio di fase 3, randomizzato, in doppio cieco, controllato con placebo per studiare l’efficacia e la sicurezza di rimegepant nella prevenzione dell’emicrania in bambini e adolescenti di età compresa tra =6 e <18 anni

A.3.2

Name or abbreviated title of the trial where available

BHV3000-315

A.4.1

Sponsor's protocol code number

BHV3000-315

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT05156398

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/285/2020

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 Holding Company Limited
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	Biohaven Pharmaceuticals Holding Company Limited
B.5.2	Functional name of contact point	Tracy Nepomuceno
B.5.3	Address:
B.5.3.1	Street Address	215 Church Street
B.5.3.2	Town/ city	New Haven, Connecticut
B.5.3.3	Post code	06510
B.5.3.4	Country	United States
B.5.4	Telephone number	012038154676
B.5.5	Fax number	0000000
B.5.6	E-mail	tracy.nepomuceno@biohavenpharma.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	Yes
D.2.1.1.1	Trade name	VYDURA 75 mg oral lyophilisate
D.2.1.1.2	Name of the Marketing Authorisation holder	Biohaven Pharmaceutical Ireland DAC
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	Rimegepant 75
D.3.2	Product code	[BHV-3000]
D.3.4	Pharmaceutical form	Orodispersible tablet
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	Rimegepant
D.3.9.2	Current sponsor code	BHV-3000
D.3.9.4	EV Substance Code	SUB215832
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	75
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	Rimegepant 25
D.3.2	Product code	[BHV-3000]
D.3.4	Pharmaceutical form	Orodispersible tablet
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	Rimegepant
D.3.9.2	Current sponsor code	BHV-3000
D.3.9.4	EV Substance Code	SUB215832
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	25
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	Orodispersible tablet
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Orodispersible tablet
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

Acute Migraine (with or without aura)

Emicrania acuta (con o senza aura)

E.1.1.1

Medical condition in easily understood language

Migraine

Emicrania

E.1.1.2

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To compare the efficacy of rimegepant to placebo as a preventive treatment for migraine in adolescents (= 12 to <18 years of age) with episodic migraine, as measured by the reduction from baseline in the mean number of migraine days per month over the entire course of the double-blind treatment phase.

Confrontare l’efficacia di rimegepant rispetto al placebo come trattamento preventivo per l’emicrania negli adolescenti (di età compresa tra >12 e <18 anni) con emicrania episodica, misurata in base alla riduzione rispetto al basale del numero medio di giorni di emicrania al mese durante l’intero corso della Fase di trattamento in doppio cieco.

E.2.2

Secondary objectives of the trial

-To compare the efficacy of rimegepant to placebo on the proportion of subjects that have at least a 50% reduction from baseline in the mean number of moderate to severe migraine days per month over the entire course of the double-blind treatment phase in adolescents with episodic migraine.
-To compare the efficacy of rimegepant to placebo on the reduction from baseline in the mean number of migraine days per month in the first 4 weeks of the double-blind treatment phase in adolescents with episodic migraine.
- To compare the change from baseline in the Pediatric Quality of Life (PedsQL™) 4.0 Generic Core Scales total score at Week 12 of the double-blind treatment phase between rimegepant and placebo in adolescents with episodic migraine.

- Confrontare l’efficacia di rimegepant rispetto al placebo sulla percentuale di soggetti che presentano una riduzione di almeno il 50% rispetto al basale nel numero medio di giorni di emicrania da moderata a grave al mese durante l’intero corso della Fase di trattamento in doppio cieco negli adolescenti con emicrania episodica
- Confrontare l’efficacia di rimegepant rispetto al placebo sulla riduzione rispetto al basale del numero medio di giorni di emicrania al mese nelle prime 4 settimane della Fase di trattamento in doppio cieco negli adolescenti con emicrania episodica
- Confrontare la variazione rispetto al basale nel punteggio totale delle Scale generiche centrali 4,0 del Questionario sulla qualità della vita in età pediatrica (Pediatric Quality of Life, PedsQL™) alla Settimana 12 della Fase di trattamento in doppio cieco tra rimegepant e placebo negli adolescenti con emicrania episodica

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Subject has at least a 6 month history of migraine (with or without aura) and including the following:
a) 14 or less headache days per month during the 3 month period prior to the Screening Visit
b) 6 or more migraine days during the Observation Period
c) 14 or less headache days during the Observation Period
d) Pediatric Migraine Disability Assessment Scale (PedMIDAS) Disability Score of >10 to =50, indicating mild (score of 11 to 30) or moderate (score of 31 to 50) disruption in daily activities, as assessed at the Baseline (Randomization) Visit
e) Ability to verbally distinguish migraine attacks from tension/cluster or other types of headaches
f) Migraine attacks, on average, lasting 4 - 72 hours if untreated
g) Subjects on prophylactic migraine medication are permitted to remain on therapy if the dose has been stable for at least 3 months (12 weeks) prior to the Screening Phase, and the dose is not expected to change during the course of the study.

2) Male and female subjects = 6 to <18 years; subjects must be less than 18 at the time of signing assent / consent.

3) Subjects must have a weight of =40 kg (child cohort requirement =15 kg) at the Screening Visit

1) Soggetto con un’anamnesi di emicrania (con o senza aura) di almeno 6 mesi, incluso quanto segue:
a) 14 o meno giorni di cefalea al mese negli ultimi 3 mesi precedenti la visita di screening
b) 6 o più giorni di emicrania durante il Periodo di osservazione
c) 14 o meno giorni di cefalea durante il Periodo di osservazione
d) punteggio di disabilità della Pediatric Migraine Disability Assessment Scale (PedMIDAS) compreso tra >10 e =50, che indica un'interruzione lieve (punteggio compreso tra 11 e 30) o moderata (punteggio compreso tra 31 e 50) delle attività quotidiane, come valutato alla visita basale (di randomizzazione)
e) Capacità di distinguere verbalmente gli attacchi di emicrania dalla cefalea tensiva o da altri tipi di mal di testa.
f) attacchi di emicrania della durata media di 4-72 ore se non trattati
g) I soggetti che assumono farmaci profilattici per l'emicrania possono rimanere in terapia se la dose è rimasta stabile per almeno 3 mesi (12 settimane) prima della fase di screening e se non si prevede una variazione della dose nel corso dello studio.

2) Soggetti di sesso maschile e femminile = da 6 a <18 anni; i soggetti devono avere meno di 18 anni al momento della firma dell'assenso/consenso

3) I soggetti devono avere un peso =40 kg (requisito della coorte infantile =15 kg) alla visita di screening.

E.4

Principal exclusion criteria

1) Subjects with a history of basilar migraine, cluster headaches, or hemiplegic migraine
2) The subject has a continuous migraine (defined as an unrelenting headache) within 1 month prior to Screening Visit.
3) The subject has a history or diagnosis of complications of migraine (including persistent aura without infarction, migrainous infarction, and migraine-aura triggered seizure) (ICHD-3 version 2018),1 chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or unusual migraine subtypes such as hemiplegic migraine (sporadic and familial), ophthalmoplegic migraine, or migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration).
4) The subject has a confounding and clinically significant pain syndrome that may interfere with the subject’s ability to participate in this study.
5) The subject has any current psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the Screening Visit.
6) History of suicidal behavior or the subject is at risk of self-harm or harm to others.
7) History of major psychiatric disorder.
8) The subject has a current diagnosis or history of substance abuse
9) The subject has a history of moderate or severe head trauma or other neurological disorder (including seizure disorder) or systemic medical disease that is, in the investigator’s opinion, likely to affect central nervous system functioning.

1) Soggetti con anamnesi di emicrania basilare, cefalea a grappolo o emicrania emiplegica.
2) Il soggetto ha un'emicrania continua (definita come un mal di testa incessante) entro 1 mese prima della visita di screening.
3) Il soggetto ha un'anamnesi o una diagnosi di complicazioni dell'emicrania (inclusa l'aura persistente senza infarto, l'infarto emicranico e la crisi scatenata dall'emicrania) (ICHD-3 versione 2018),1 cefalea di tipo tensivo cronica, cefalea ipnica, cefalea a grappolo, emicrania continua, nuova cefalea persistente quotidiana, o sottotipi di emicrania insoliti come l'emicrania emiplegica (sporadica e familiare), l'emicrania oftalmoplegica o l'emicrania con accompagnamenti neurologici non tipici dell'aura emicranica (diplopia, alterazione della coscienza o lunga durata).
4) Il soggetto ha una sindrome del dolore confondente e clinicamente significativa che può interferire con la sua capacità di partecipare a questo studio.
5) Il soggetto presenta una condizione psichiatrica attuale non controllata e/o non trattata per almeno 6 mesi prima della visita di screening.
6) Anamnesi di comportamenti suicidi o rischio di autolesionismo o di danni ad altri.
7) Storia di disturbo psichiatrico maggiore.
8) Il soggetto ha una diagnosi attuale o una storia di abuso di sostanze.
9) Il soggetto ha un'anamnesi di trauma cranico moderato o grave o di altri disturbi neurologici (compresi i disturbi convulsivi) o di malattie sistemiche che, a giudizio dello sperimentatore, possono influire sul funzionamento del sistema nervoso centrale.

E.5 End points

E.5.1

Primary end point(s)

Change from baseline (observation period) in the mean number of migraine days per month over the entire course (Weeks 1 to 12) of the double-blind treatment phase in adolescents with episodic migraine

Variazione rispetto al basale (periodo di osservazione) nel numero medio di giorni di emicrania al mese durante l’intero ciclo (Settimane da 1 a 12) della Fase di trattamento in doppio cieco negli adolescenti con emicrania episodica.

E.5.1.1

Timepoint(s) of evaluation of this end point

over the entire course (Weeks 1 to 12) of the double-blind treatment phase

per l'intero corso (settimane da 1 a 12) della fase di trattamento in doppio cieco

E.5.2

Secondary end point(s)

Key Secondary Endpoints:
- Achievement of at least a 50% reduction from baseline in the mean number of moderate to severe migraine days per month over the entire course of the double-blind treatment phase in adolescents with episodic migraine.
- Change from baseline in the mean number of migraine days per month in the first 4 weeks (Weeks 1 through 4) of the double-blind treatment phase in adolescents with episodic migraine.
- The mean change from baseline in the Pediatric Quality of Life (PedsQL) total score at Week 12 of the double-blind treatment phase in adolescents with episodic migraine.
Refer to Protocol for full list of Secondary endpoints

- Raggiungimento di una riduzione di almeno il 50% rispetto al basale nel numero medio di giorni di emicrania da moderata a grave al mese durante l’intero corso della Fase di trattamento in doppio cieco negli adolescenti con emicrania episodica.
- Variazione rispetto al basale nel numero medio di giorni di emicrania al mese nelle prime 4 settimane (dalla Settimana 1 alla 4) della Fase di trattamento in doppio cieco negli adolescenti con emicrania episodica.
- Variazione media rispetto al basale nel punteggio totale del Questionario sulla qualità della vita in età pediatrica (PedsQLTM) alla Settimana 12 della Fase di trattamento in doppio cieco negli adolescenti con emicrania episodica.
Fare riferimento al protocollo per l'elenco completo degli endpoint secondari.

E.5.2.1

Timepoint(s) of evaluation of this end point

Timepoints for evaluation of Key Secondary Endpoints:
¿ Achievement of at least a 50% reduction from baseline in the mean number of moderate to severe migraine days per month over the entire course of the double-blind treatment phase in adolescents with episodic migraine.
¿ Change from baseline in the mean number of migraine days per month in the first 4 weeks (Weeks 1 through 4) of the double-blind treatment phase in adolescents with episodic migraine.
¿ The mean change from baseline in the PedsQL total score at Week 12 of the double-blind treatment phase in adolescents with episodic migraine.
For timepoints for all the other secondary endpoints please refer to the Protocol

- Raggiungimento di una riduzione di almeno il 50% rispetto al basale nel numero medio di giorni di emicrania da moderata a grave al mese durante l’intero corso della Fase di trattamento in doppio cieco negli adolescenti con emicrania episodica.
- Variazione rispetto al basale nel numero medio di giorni di emicrania al mese nelle prime 4 settimane (dalla Settimana 1 alla 4) della Fase di trattamento in doppio cieco negli adolescenti con emicrania episodica.
- Variazione media rispetto al basale nel punteggio totale del Questionario sulla qualità della vita in età pediatrica (PedsQLTM) alla Settimana 12 della Fase di trattamento in doppio cieco negli adolescenti con emicrania episodica.
Per i tempi relativi a tutti gli altri endpoint secondari si rimanda al Protocollo.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

Yes

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

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

Dopo la fase di trattamento in doppio cieco, è prevista una fase di estensione in aperto facoltativa

There is an optional open-label, extension phase following the double-blind, treatment phase

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

Israel

United States

France

Poland

Sweden

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

LSLV

LVLS

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

Yes

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)

Yes

F.1.1.5.1

Number of subjects for this age range:

160

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

480

F.1.2

Adults (18-64 years)

F.1.3

Elderly (>=65 years)

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

110

F.4.2

For a multinational trial

F.4.2.1

In the EEA

300

F.4.2.2

In the whole clinical trial

640

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)

The choice of further therapy at the end of the clinical trial depends on the patient's individual needs and is left at the physician's discretion. After the end of the study, the Study drug will not be provided.

La scelta di un'ulteriore terapia al termine dello studio clinico dipende dalle esigenze individuali del paziente ed è lasciata alla discrezione del medico. Al termine dello studio, il farmaco in studio non verrà più fornito.

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

2022-10-07

Ethics Committee Opinion of the trial application

Withdrawn

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-12-13

P. End of Trial
P.	End of Trial Status

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Clinical trials