Clinical Trials Register

Summary
EudraCT Number:	2018-001311-79
Sponsor's Protocol Code Number:	JZP080-301
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2020-11-04
Trial results	View 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

2018-001311-79

A.3

Full title of the trial

A Double-blind, Placebo-controlled, Randomized Withdrawal, Multicenter Study of the Efficacy and Safety of JZP-258 in the Treatment of Idiopathic Hypersomnia (IH) with an Open-label Safety Extension

Studio multicentrico, in doppio cieco, controllato con placebo, con sospensione randomizzata volto a valutare l’efficacia e la sicurezza di JZP-258 nel trattamento dell’ipersonnia idiopatica (IH) con un’estensione in aperto di sicurezza

A.3.1

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

Study on the Effect of JZP-258 in Patients with Idiopathic Hypersomnia

Studio sull'effetto di JZP-258 in pazienti con ipersonnia idiopatica

A.3.2

Name or abbreviated title of the trial where available

A.4.1

Sponsor's protocol code number

JZP080-301

A.5.4

Other Identifiers

Name:

IND

Number:

49,641

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	JAZZ 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	Jazz Pharmaceuticals
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	Jazz Pharmaceuticals
B.5.2	Functional name of contact point	Ian Foley
B.5.3	Address:
B.5.3.1	Street Address	Wing B, Building 5700,Spires House, John Smith Drive,Oxford Business Park
B.5.3.2	Town/ city	Oxford
B.5.3.3	Post code	OX4 2RW
B.5.3.4	Country	United Kingdom
B.5.4	Telephone number	004407392086433
B.5.5	Fax number	00000000
B.5.6	E-mail	ian.foley@jazzpharma.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	JZP-258, 500 mg/ml oral solution
D.3.2	Product code	[JZP-258]
D.3.4	Pharmaceutical form	Oral solution
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	oxybate (4-hydroxybutanoic acid, ¿- hydroxybutyrate, 4-hydroxybutyrate, or GHB)
D.3.9.1	CAS number	502-85-2
D.3.9.2	Current sponsor code	na
D.3.9.3	Other descriptive name	oxybate mixed salt solution: sodium oxybate, potassium oxybate, calcium oxybate,magnezium oxybate
D.3.9.4	EV Substance Code	SUB14731MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g/ml gram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	5
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	Oral solution
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

Treatment of Idiopathic Hypersomnia

Trattamento dell’ipersonnia idiopatica

E.1.1.1

Medical condition in easily understood language

Sleep Disorder

Disordine del sonno

E.1.1.2

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	LLT
E.1.2	Classification code	10015595
E.1.2	Term	Excessive daytime sleepiness
E.1.2	System Organ Class	100000004852

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	10040989
E.1.2	Term	Sleep disorder NOS
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 this study is to evaluate the efficacy of JZP-258 in the treatment of IH.

L'obiettivo primario valutare l’efficacia di JZP-258 nel trattamento dell’IH.

E.2.2

Secondary objectives of the trial

The secondary objective of this study is to evaluate the safety of JZP-258 in the treatment of IH

Obiettivo secondario: valutare la sicurezza di JZP-258 nel trattamento dell’IH.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

•Male or female between 18 and 75 years of age, inclusive, at the time of consent.
•Have a primary diagnosis of IH according to the International Classification of Sleep Disorders ICSD-2 or ICSD-3 criteria. If documentation of diagnosis of IH is unavailable or the Investigator deems it necessary to confirm diagnosis, diagnostic testing will be conducted during the Screening Period to confirm the diagnosis of IH according to ICSD-3 criteria. If the Investigator suspects a patient with a previous clinical diagnosis of narcolepsy has IH, a screening PSG and MSLT may be performed to confirm the diagnosis of IH, provided there is no history of cataplexy, no history of SOREMP on nocturnal PSG, and no history of =2 SOREMPs on MSLT.
•At the Screening Visit and the Baseline Visit, subjects who are not on Xyrem at study entry must have Epworth Sleepiness Scale (ESS) scores = 11 (as assessed with a look-back period of 1 week). Any subject who will wash out of medications during the Screening Period that could impact ESS score at Screening (eg, stimulant, alerting agent when not taken at a stable dose) will only have to meet the ESS score = 11 requirement at the Baseline visit, after they have washed out of their medication.
•If currently treated with Xyrem, must have documented clinical improvement of EDS after the initiation of Xyrem per Investigator’s clinical judgment.
•Average nightly total sleep time of = 7 hours, per subject history. Average nightly total sleep time will be confirmed by Investigator’s review of sleep diaries collected during the final 2 weeks of the Screening Period.
•If currently treated with stimulants and/or alerting agents or nicotine replacement therapy, must have been taking the same regimen and dose for at least 2 months prior to screening and must agree to take the same dose leading up to and throughout the Double-blind Randomized Withdrawal Period.
•Have used a medically acceptable method of contraception for at least 2 months prior to the first dose of study drug and consent to use a medically acceptable method of contraception from the first dose of study drug, throughout the entire study period, and for 90 days after the last dose of study drug.

• Soggetti di sesso maschile o femminile che abbiano compiuto un’età compresa tra 18 e 75 anni al momento del consenso.
• Avere una diagnosi primaria di IH secondo i criteri ICSD-2 o ICSD-3 della Classificazione internazionale dei disturbi del sonno. Qualora la documentazione della diagnosi di IH sia disponibile o lo Sperimentatore ritenga necessario confermare la diagnosi, durante il Periodo di screening saranno condotti esami diagnostici per confermare la diagnosi di IH secondo i criteri ICSD-3. Qualora lo Sperimentatore sospetti che un paziente con una pregressa diagnosi clinica di narcolessia sia affetto da IH, potrebbero essere condotti unapolisonnografia (PSG) e un test di latenza multipla del sonno (MSLT) di screening per confermare la diagnosi di IH, purché non siano presenti anamnesi di cataplessia, anamnesi di comparsa di un periodo di sonno con movimenti oculari rapidi (SOREMP) alla PSG notturna e anamnesi di SOREMP = 2 al test MSLT.
• Alla Visita di screening e alla Visita basale, i soggetti che non assumono Xyrem al momento dell’ingresso nello studio devono presentare un punteggio = 11 secondo la Scala della sonnolenza di Epworth (Epworth Sleepiness Scale, ESS) (come valutato con un periodo di indagine retrospettiva di 1 settimana). Qualsiasi soggetto che durante il Periodo di screening sospenda (washout) i farmaci che potrebbero avere un impatto sul punteggio ESS allo Screening (per es. agente stimolante, allertante quando non assunto a una dose stabile) dovrà unicamente soddisfare il requisito di un punteggio ESS = 11 alla Visita basale, dopo il periodo di washout del proprio farmaco.
• Qualora i soggetti siano attualmente trattati con Xyrem, devono manifestare un miglioramento clinico documentato dell’ESD secondo il giudizio clinico dello Sperimentatore.
• Anamnesi della durata media del sonno notturno totale = 7 ore per soggetto. La durata media del sonno notturno totale sarà confermata mediante disamina da parte dello Sperimentatore dei diari del sonno, raccolti durante le 2 settimane finali del Periodo di screening.
• Qualora i soggetti siano attualmente trattati con agenti stimolanti e/o allertanti o una terapia sostitutiva della nicotina, devono avere assunte la stessa posologia e la stessa dose per almeno 2 mesi prima dello Screening e devono accettare di assumere la stessa dose fino al e per l’intera durata del Periodo di sospensione randomizzata in doppio cieco.
• I soggetti devono avere adottato un metodo contraccettivo accettabile dal punto di vista medico per almeno 2 mesi antecedenti la prima dose di farmaco dello studio e acconsentire all’utilizzo di un metodo contraccettivo accettabile dal punto di vista medico a partire dalla prima dose di farmaco dello studio, per l’intera durata del periodo dello studio e per 90 giorni successivi all’ultima dose di farmaco dello studio.

E.4

Principal exclusion criteria

•Hypersomnia due to another medical, behavioral, or psychiatric disorder condition (eg, narcolepsy, multiple sclerosis, Parkinson’s Disease, stroke).
•Evidence of untreated or inadequately treated sleep-disordered breathing including:
a.Presence of clinically significant and untreated obstructive or central sleep apnea as determined by the Investigator or documented previously;
or documentation of one of the following:
b.Apnea Index > 10 on any historical test (unless a subsequent Apnea Index = 10 was reported after treatment, and the subject agrees to use this treatment throughout the duration of the study) or during the Screening PSG (if done) while on obstructive sleep apnea treatment or untreated; or
c.Clinically significant hypoventilation; or
d.Noncompliance with primary obstructive sleep apnea therapy. (Compliance defined as positive airway pressure use of = 4 hours per night on = 70% of nights [= 5 of 7 nights / week], historical report [with Investigator concurrence] of use of an oral appliance on = 70% of nights [= 5 of 7 nights/week], or receipt of an effective surgical intervention for obstructive sleep apnea symptoms.)
•Clinically significant parasomnias (eg, sleep walking, rapid eye movement sleep behavior disorder, etc.).
•Current or past (within 1 year) major depressive episode according to DSM-5 criteria. Patients with depression under control are allowed per the judgment of the Investigator or the treating physician and the anti-depressant treatment has to be stable for at least 6 months prior to Screening and remain stable for the duration of the study.
•Current suicidal risk as determined from history, by presence of active suicidal ideation as indicated by positive response to item #4 or #5 on the C-SSRS, or any history of suicide attempt.
•Occupation requiring nighttime shift work or variable shift work with early work start times or other occupations that could affect the safety of the subject per the judgment of the Investigator.
•Treatment or planned treatment with any CNS sedating agents, including but not limited to benzodiazepines or other sedating anxiolytics, sedating antidepressants, hypnotics, sedatives, neuroleptics, opioids, barbiturates, phenytoin, melatonin, ethosuximide, medications containing valproic acid or its sodium salt (eg, depakene and Depakote), or any other medication in which the subject experiences sedation are prohibited during the study. Treatment must have been discontinued within 2 weeks or 5 half-lives, whichever is longer, prior to enrollment. (Discontinuation for the purpose of study enrollment is permitted only if considered safe and medically appropriate by the Investigator, and approved by the Medical Monitor.) The Investigator must ensure that discontinuation from these medications is medically supervised. Subjects must abstain from these medications during the study.
•Current or past substance use disorder (including alcohol) according to DSM-5 criteria, or the subject is unwilling to refrain from consuming alcohol, cannabinoids, or prohibited medications during the study.

Ipersonnia dovuta a un’altra condizione associata a un disturbo medico, comportamentale o psichiatrico (per es. narcolessia, sclerosi multipla, malattia di Parkinson, ictus).
• Evidenza di disturbi respiratori durante il sonno non trattati o trattati in maniera inadeguata, tra cui:
a. Presenza di apnea notturna centrale o ostruttiva clinicamente significativa e non trattata, determinata dallo sperimentatore o precedentemente documentata;
oppure documentazione di uno dei seguenti:
b. Indice di apnea > 10 come misurata mediante qualsiasi test storico (salvo referto di un successivo indice di apnea = 10 a seguito del trattamento e consenso del soggetto all’utilizzo di questo trattamento per l’intera durata dello studio) o durante la PSG di screening (ove effettuata) nel corso di apnea ostruttiva del sonno trattata o non trattata; oppure
c. Ipoventilazione clinicamente significativa; oppure
d. Mancata aderenza alla terapia primaria per l’apnea ostruttiva del sonno (l’aderenza è definita come l’utilizzo di una pressione positiva delle vie aeree = 4 ore a notte per almeno il 70% delle notti [= 5 su 7 notti/settimana], referto storico [con il consenso dello Sperimentatore] dell’utilizzo di dispositivi orali per almeno il 70% delle notti [= 5 su 7 notti/settimana] o ricezione di un intervento chirurgico efficace contro i sintomi di apnea ostruttiva del sonno).
• Parasonnie clinicamente significative (per es. sonnambulismo, disturbo comportamentale nel sonno con rapidi movimenti oculari ecc.).
• Episodi depressivi maggiori attuali o pregressi (entro 1 anno) secondo i criteri del DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition [Quinta edizione del Manuale diagnostico e statistico dei disturbi mentali]). I pazienti con depressione sotto controllo sono consentiti secondo il giudizio dello Sperimentatore o del medico curante e il trattamento antidepressivo deve essere stabile per almeno 6 mesi precedenti lo Screening e rimanere stabile per la durata dello studio.
• Attuale rischio suicidario, come determinato mediante anamnesi, presenza di idee suicide attive come indicato da una risposta positiva all’item n. 4 o 5 della Scala per la valutazione della gravità delle idee e dei comportamenti suicidi formulata dalla Columbia University (Columbia-Suicide Severity Rating Scale, C-SSRS) o qualsiasi anamnesi di tentativo di suicidio.
• Occupazione richiedente un lavoro con turni notturni o turni variabili con inizio della giornata lavorativa nelle prime ore del mattino o altre occupazioni che potrebbero incidere sulla sicurezza del soggetto, secondo il giudizio dello Sperimentatore.
• Trattamento o trattamento programmato con agenti ad azione sedativa del sistema nervoso centrale (SNC), compresi ma non limitati a benzodiazepine o altri ansiolitici sedativi, antidepressivi sedativi, ipnotici, sedativi, neurolettici, oppioidi, barbiturici, fenitoina, melatonina, etosuccimide, assunzione di farmaci contenenti acido valproico o il relativo sale sodico (per es. Depakene e Depakote) o di qualsiasi altro farmaco, in cui il soggetto manifesti sedazione sono vietati durante lo studio. Il trattamento deve essere stato interrotto entro2 settimane o 5 emivite, a seconda di quale periodo è più lungo, prima dell’arruolamento (l’interruzione ai fini dell’arruolamento nello studio è consentita solo se considerata sicura e clinicamente appropriata dallo Sperimentatore e approvata dal Responsabile del monitoraggio medico). Lo Sperimentatore deve assicurare che la sospensione di questi farmaci sia effettuata sotto supervisione medica. I soggetti devono astenersi da questi farmaci durante lo studio.
• Disturbo attuale o pregresso da uso di sostanze (anche alcoliche) secondo i criteri del DSM-5 o soggetto non disposto ad astenersi dal consumo di alcol, cannabinoidi o farmaci vietati durante lo studio.

E.5 End points

E.5.1

Primary end point(s)

ESS, as assessed by the change in ESS from the end of the Stable
Dose Period to the end of the Double-blind Randomized Withdrawal Period

ESS, come osservato dal cambiamento di ESS dalla fine del Periodo di dose stabile fino alla fine del Periodo di sospensione randomizzata in doppio cieco.

E.5.1.1

Timepoint(s) of evaluation of this end point

at the end of the Stable Dose Period as fixed effects

alla fine del periodo di dose stabile come effetti fissi

E.5.2

Secondary end point(s)

Key Efficacy Endpoint:
Patient Global Impression of change assessed by the proportion of subjects reporting worsening of symptoms (minimally, much or very much) at the end of the Double-blind Randomized Withdrawal Period.
Hypersomnolence Severity Scale:Change in total score from the end of the Stable Dose Period to the end of the Double-blind Randomized Withdrawal Period.
Other Secondary Efficacy Endpoints :
Clinical Global Impression of change (CGIc): proportion of subjects reported as worse(minimally, much or very much) at the end of the Double-blind Randomized Withdrawal Period
FOSQ-10: Change in total score from the end of the Stable Dose Period to the end of the Double-blind Randomized Withdrawal Period

endpoint di efficacia secondari
Impressione globale di cambiamento riferita dal paziente (PGIc): percentuale di soggetti che riferiscono un peggioramento dei sintomi (lieve, importante o eccezionale) sulla PGIc alla fine del Periodo di sospensione randomizzata in doppio cieco.
• Scala della gravità dell’ipersonnolenza (Hypersomnolence Severity Scale, HSS): Variazione nel punteggio totale osservato dalla fine del Periodo di dose stabile fino alla fine del Periodo di sospensione randomizzata in doppio cieco

E.5.2.1

Timepoint(s) of evaluation of this end point

at the end of Double-blind Randomized Withdrawal Period

alla fine del Periodo di sospensione randomizzata in doppio cieco.

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

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

E.8.1.6

Cross over

E.8.1.7

Other

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

Belgium

Czechia

Finland

France

Germany

Italy

Poland

Spain

United Kingdom

United States

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 visit of the last subject

ultima visita dell'ultimo paziente

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:

126

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

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

F.4.2.2

In the whole clinical trial

140

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)

JZP-258 will not be available to the subject after their participation in
the study has ended

JZP-258 non sarà disponibile per il soggetto dopo che la partecipazione allo studio è finita.

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

2019-12-18

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-03-20

P. End of Trial
P.	End of Trial Status	Prematurely Ended

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