Clinical Trials Register

Summary
EudraCT Number:	2016-000826-21
Sponsor's Protocol Code Number:	AC-078A201
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2016-10-04
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

Spain - AEMPS

A.2

EudraCT number

2016-000826-21

A.3

Full title of the trial

Multi-center, double-blind, randomized, placebo-controlled, active reference, parallel-group, polysomnography dose response study to assess the efficacy and safety of ACT-541468 in adult subjects with insomnia disorder

Estudio multicéntrico, doble ciego, aleatorizado, controlado con placebo, de referencia activa, con grupos paralelos y polisomnográfico de respuesta a una dosis dada para evaluar la eficacia y la seguridad de ACT-541468 en sujetos adultos con insomnio.

A.3.1

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

Study to assess the efficacy and safety of ACT-541468 in adult subjects suffering from difficulties to sleep

Estudio para evaluar la eficacia y seguridad de ACT-541468 en sujetos adultos que sufren dificultades para dormir.

A.4.1

Sponsor's protocol code number

AC-078A201

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT02839200

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	Actelion Pharmaceuticals Ltd
B.1.3.4	Country	Switzerland
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	Actelion Pharmaceuticals Ltd
B.4.2	Country	Switzerland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Actelion Pharmaceuticals Ltd
B.5.2	Functional name of contact point	Clinical Trial Disclosure Desk
B.5.3	Address:
B.5.3.1	Street Address	Gewerbestrasse 16
B.5.3.2	Town/ city	Allschwil
B.5.3.3	Post code	4123
B.5.3.4	Country	Switzerland
B.5.6	E-mail	clinical-trials-disclosure@actelion.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	-
D.3.2	Product code	ACT-541468
D.3.4	Pharmaceutical form	Capsule, hard
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	-
D.3.9.2	Current sponsor code	ACT-541468
D.3.9.4	EV Substance Code	SUB169826
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	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	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	-
D.3.2	Product code	ACT-541468
D.3.4	Pharmaceutical form	Capsule, hard
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	-
D.3.9.2	Current sponsor code	ACT-541468
D.3.9.4	EV Substance Code	SUB169826
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	10
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: 3
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	-
D.3.2	Product code	ACT-541468
D.3.4	Pharmaceutical form	Capsule, hard
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	-
D.3.9.2	Current sponsor code	ACT-541468
D.3.9.4	EV Substance Code	SUB169826
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	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: 4
D.1.2 and D.1.3	IMP Role	Comparator
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	Stilnox®
D.2.1.1.2	Name of the Marketing Authorisation holder	Sanofi-Aventis Deutschland GmbH
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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.3.4	Pharmaceutical form	Film-coated 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	Zolpidem Tartrate
D.3.9.1	CAS number	99294-93-6
D.3.9.4	EV Substance Code	SUB05192MIG
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	10
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, hard
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	Capsule, hard
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

Insomnia disorder

Trastorno de insomnio

E.1.1.1

Medical condition in easily understood language

Difficulty to sleep

Dificultad para dormir

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	19.0
E.1.2	Level	PT
E.1.2	Classification code	10022437
E.1.2	Term	Insomnia
E.1.2	System Organ Class	10037175 - Psychiatric disorders

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 dose-response of ACT-541468 on the change of WASO [Wake After Sleep Onset] assessed by Polysomnography [PSG] after treatment on Days 1 and 2

El objetivo principal del estudio es evaluar la respuesta a una dosis de ACT-541468 sobre el cambio del despertar después del inicio del sueño (WASO; minutos) determinada mediante polisomnografía (PSG) después del tratamiento los días 1 y 2.

E.2.2

Secondary objectives of the trial

The secondary objective of the study is to evaluate the dose response of ACT-541468 on Latency to Persistent Sleep (LPS) on Days 1&2 and Subjective Latency to Sleep Onset (sLSO) and subjective Wake After Sleep Onset (sWASO) at Week 4

El objetivo secundario del estudio consiste en evaluar la respuesta a una dosis de ACT-541468 sobre la latencia para el sueño continuado (LPS) los días 1 y 2 y la latencia subjetiva después del inicio del sueño (sLSO) y el WASO subjetivo (sWASO) en la semana 4.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Signed informed consent prior to any study-mandated procedure
- Male or female aged 18-64 years (inclusive)
- Women of childbearing potential must have a negative and urine pregnancy test and use reliable methods of contraception up to 30 days after EOT
- Body mass index (BMI): 18.5 <= BMI (kg/m2) < 32.0
- Insomnia disorder according to DSM-5 criteria
- Insufficient sleep quantity as collected subjectively in the sleep diary and validated objectively by polysomnography.
- Insomnia Severity Index score >= 15.

- Firma del consentimiento informado antes de realizar cualquier procedimiento del estudio.
- Varón o mujer de 18 a 64 años (ambos inclusive).
- Las mujeres fértiles deben aportar una prueba de embarazo en sangre y orina negativa y un compromiso de someterse a pruebas de embarazo hasta 30 días después del FdT.
- Índice de masa corporal (IMC): 18,5 <= IMC (kg/m2) < 32,0.
- Insomnio con arreglo a los criterios del DSM-5.
- Cantidad de sueño insuficiente como subjetivamente recogido en el diario de sueño y validado objetivamente mediante polisomnografía.
- Puntuación en el Índice de gravedad del insomnio (isi©) >= 15

E.4

Principal exclusion criteria

- Any current history of sleep disorder other than insomnia, or any lifetime history of related breathing disorder, periodic limb movement disorder, restless legs syndrome, circadian rhythm disorder, rapid eye movement (REM) behavior disorder, or narcolepsy.
- Self-reported usual daytime napping ≥ 1 hour per day, and ≥ 3 days per week.
- Caffeine consumption >= 600 mg per day.
- Shift work within 2 weeks prior to the screening visit, or planned shift work during study.
- Travel >= 3 time zones within 1 week prior to the screening visit, or planned travel >= 3 time zones during study.
- Hematology or biochemistry test results deviating from the normal range to a clinically relevant extent as per judgment of the Investigator.
- AST and/or ALT > 2 × ULN and/or direct bilirubin > 1.5 × ULN - Severe renal impairment (known or defined as estimated creatinine clearance < 30 mL/min).
- History or clinical evidence of any disease or medical condition or treatment, which may put the subject at risk of participation in the study or may interfere with the study assessments.
- Any circumstances or conditions, which, in the opinion of the investigator, may affect the subject's full participation in the study or compliance with the protocol.

- Cualquier trastorno del sueño distinto de insomnio, o antecedentes de trastorno respiratorio relacionado, trastorno de movimientos periódicos de las extremidades, síndrome de piernas inquietas, trastorno del ritmo circadiano, trastorno de conducta del sueño REM o narcolepsia.
- Siesta habitual por el día autorreferida >= 1 hora al día y >= 3 días a la semana.
- Consumo de cafeína >= 600 mg al día.
- Trabajo por turnos en las 2 semanas anteriores a la visita de selección, o trabajo por turnos planificado durante el estudio.
- Viajes a >= 3 zonas horarias dentro de la semana anterior a la visita de selección o viajes planificados a >= 3 zonas horarias durante el estudio.
-Resultados de pruebas de hematología y bioquímica sanguínea que se desvían del intervalo normal de forma clínicamente importante según criterio del investigador.
- Aspartato aminotransferasa y/o alanina aminotransferasa > 2 x el límite superior de la normalidad (LSN) y/o bilirrubina directa > 1.5 x LSN - Insuficiencia renal grave (salvo antecedentes documentados de síndrome de Gilbert).
- Estado médico inestable, trastorno médico significativo o enfermedad aguda dentro del mes anterior a la visita de selección, que en opinión del investigador podría afectar a la seguridad del sujeto o interferir con las evaluaciones del estudio.
- Cualquier circunstancia o situación que, en opinión del investigador, pueda afectar a la plena participación del sujeto en el estudio o el cumplimiento del protocolo

E.5 End points

E.5.1

Primary end point(s)

Change of WASO ( Wake after Sleep Onset) from baseline to Days 1 & 2 as determined by
Polysomnography (PSG).

Variación de WASO (min) desde el inicio hasta los días 1 y 2 según lo determinado por polisomnografía (PSG).
El WASO (min) es el tiempo que se ha permanecido despierto después del inicio del sueño persistente hasta que se encienden las luces determinado mediante PSG.

E.5.1.1

Timepoint(s) of evaluation of this end point

From Baseline to Days 1&2

Desde el inicio hasta los Días 1 y 2.

E.5.2

Secondary end point(s)

1- Sleep initiation endpoints including:
Change from baseline to Days 1 & 2 in mean LPS (Latency to Persistent Sleep);
Change from baseline to Week 4 in mean sLSO (self reported Latency to Sleep Onset)
2- Sleep maintenance endpoint:
Change from baseline to Week 4 in mean sWASO [self-reported Subjective Wake after Sleep Onset]

1- Criterios de valoración de inicio del sueño:
Variación desde el inicioa hasta los días 1 y 2 en el LPS medio.
El LPS (min) es el tiempo desde el inicio del registro hasta el principio de las 20 primeras epochs continuas (es decir, 10 minutos) calificadas como no-despierto, es decir, epoch calificadas como fase 1 del sueño (S1), fase 2 del sueño (S2), fase 3 del sueño (sueño REM), determinado mediante PSG.
Variación desde el inicioc hasta la semana 4 en el sLSO subjetivo medio.
El sLSO es el tiempo que el sujeto afirma que tarda en quedarse dormido, según lo indicado en el diario de sueño.
2- Criterios de valoración de mantenimiento del sueño:
Variación desde el inicioc hasta la semana 4 en el sWASO subjetivo medio.
El sWASO es el tiempo que el sujeto afirma que ha permanecido dormido después del inicio del sueño, según lo indicado en el diario de sueño.

E.5.2.1

Timepoint(s) of evaluation of this end point

LPS: From Baseline to Days 1&2 ;
sLSO: From Baseline to Week 4;
sWASO: From Baseline to Week 4.

LPS: desde el inicio hasta los Días 1 y 2;
sLSO: desde el inicio hasta hasta la semana 4;
sWASO: desde el inicio hasta hasta la semana 4.

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

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

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)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

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

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

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

Germany

Hungary

Israel

Spain

Sweden

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 Last Subject

Última visita del último sujeto

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:

300

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

F.4.2

For a multinational trial

F.4.2.1

In the EEA

180

F.4.2.2

In the whole clinical trial

300

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)

After the subject’s study completion or premature withdrawal from the study, whichever applies, the
investigator will explain to subjects what treatment(s) / medical care is necessary and available according
to local regulations

Después de que el sujeto finalice el estudio o la retirada prematura del estudio, según corresponda, el investigador le explicará a los sujetos que tratamiento (s) / atención médica es necesaria y disponible de acuerdo a las regulaciones locales.

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

2016-09-19

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-09-02

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2017-06-20

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Clinical trials