Clinical Trials Register

Summary
EudraCT Number:	2015-002876-25
Sponsor's Protocol Code Number:	178-CL-206A
National Competent Authority:	Lithuania - SMCA
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2016-01-28
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Lithuania - SMCA

A.2

EudraCT number

2015-002876-25

A.3

Full title of the trial

An Open-label, Baseline-controlled, Multicenter, Phase 3 Dose-titration Study Followed by a Fixed-dose Observation Period to Evaluate Efficacy, Safety and Pharmacokinetics of Mirabegron in Children and Adolescents From 3 to Less Than 18 Years of Age With Neurogenic Detrusor Overactivity (NDO) on Clean Intermittent Catheterization (CIC)

A.3.1

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

A study to investigate how effective and safe the study medication ‘mirabegron’ is and how long it stays in the body in children and adolescents aged 3 to less than 18 years with symptoms of an overactive bladder with a neurologic cause.

A.3.2

Name or abbreviated title of the trial where available

Crocodile Study

A.4.1

Sponsor's protocol code number

178-CL-206A

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/056/2017

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Astellas Pharma Europe B.V.
B.1.3.4	Country	Netherlands
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	Astellas Pharma Europe B.V.
B.4.2	Country	Netherlands
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Astellas Pharma Europe B.V. - Global Development Operations
B.5.2	Functional name of contact point	Service Desk
B.5.3	Address:
B.5.3.1	Street Address	Sylviusweg 62
B.5.3.2	Town/ city	Leiden
B.5.3.3	Post code	2333 BE
B.5.3.4	Country	Netherlands
B.5.4	Telephone number	+31715455878
B.5.5	Fax number	+31715455224
B.5.6	E-mail	contact@nl.astellas.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	Betmiga
D.2.1.1.2	Name of the Marketing Authorisation holder	Astellas Pharma Europe B.V.
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Mirabegron
D.3.4	Pharmaceutical form	Prolonged-release 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	MIRABEGRON
D.3.9.1	CAS number	223673-61-8
D.3.9.3	Other descriptive name	MIRABEGRON
D.3.9.4	EV Substance Code	SUB32690
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: 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	Yes
D.2.1.1.1	Trade name	Betmiga
D.2.1.1.2	Name of the Marketing Authorisation holder	Astellas Pharma Europe B.V.
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Mirabegron
D.3.4	Pharmaceutical form	Prolonged-release 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	MIRABEGRON
D.3.9.1	CAS number	223673-61-8
D.3.9.3	Other descriptive name	MIRABEGRON
D.3.9.4	EV Substance Code	SUB32690
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	50
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	mirabegron
D.3.2	Product code	YM178
D.3.4	Pharmaceutical form	Granules for oral suspension
D.3.4.1	Specific paediatric formulation	Yes
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	MIRABEGRON
D.3.9.1	CAS number	223673-61-8
D.3.9.2	Current sponsor code	YM178
D.3.9.3	Other descriptive name	MIRABEGRON
D.3.9.4	EV Substance Code	SUB32690
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	8
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Neurogenic detrusor overactivity (NDO)

E.1.1.1

Medical condition in easily understood language

-not being able to control urination (incontinence)
-strong urge to urinate

E.1.1.2

Therapeutic area

Body processes [G] - Biological Phenomena [G16]

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	10012547
E.1.2	Term	Detrusor hyperreflexia
E.1.2	System Organ Class	100000004857

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	10059617
E.1.2	Term	Overactive bladder
E.1.2	System Organ Class	100000004857

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 evaluate the efficacy of mirabegron after multiple-dose administration in the pediatric population.

E.2.2

Secondary objectives of the trial

To evaluate the safety and tolerability of mirabegron after multiple-dose administration in the pediatric population.
To evaluate the pharmacokinetics of mirabegron after multiple-dose administration in the pediatric population.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Independent Ethics Committee (IEC)/Institutional Review Board (IRB)-approved written Informed Consent and privacy language as per national regulations must be obtained from the subject and/or from the subject’s parent(s) or legal guardian(s) prior to any study-related procedures (including discontinuation of prohibited medication, if applicable); assent by the subject is given as required by local law.
2. Subject is male or female from 3 to less than 18 years of age.
3. Subject has a body weight of ≥ 11 kg.
4. Subject suffers from NDO confirmed by urodynamic investigation at baseline. The diagnosis of NDO must be confirmed by the presence of at least 1 involuntary destrusor contraction > 15 cm H2O from baseline destrusor pressure, and/or a decrease in compliance leading to an increase in baseline detrusor pressure of > 20 cm H2O.
5. Subject has been using CIC for at least 4 weeks prior to visit 1/screening.
6. Subject has a current indication for drug therapy to manage NDO.
7. Subject is able to take the study drugs in accordance with the protocol.
8. Female subject must either:
Be of nonchildbearing potential:
- Clearly premenarchal or in the judgment of the investigator is premenarchal,
- Documented surgically sterile,
or, if of childbearing potential:
- Agree not to try to become pregnant during the study and for 28 days after the final study drug administration,
- And have a negative pregnancy test at visit 1/screening and at visit 3/baseline,
- And, if sexually active must agree to use a highly effective method of birth control, which includes established use of oral, injected or implanted hormonal methods of contraception, OR placement of an intrauterine device (IUD) or intrauterine system (IUS). Birth control must be practiced from visit 1/screening and continuing throughout the study period, and for 28 days after the final study drug administration.
9. Male subject and their female spouse/partner who are of childbearing potential must be using a highly effective method of birth control, which includes established use of oral, injected or implanted hormonal methods of contraception, placement of an IUD or IUS. Birth control must be practiced from visit 1/screening and continuing throughout the study period, and for 28 days after the final study drug administration.
10. Female subject must not be breastfeeding from visit 1/screening until 28 days after last study drug administration.
11. Subject and subject’s parent(s)/legal guardian(s) agree that the subject will not participate in another interventional study while participating in the study.
12. Subject and subject’s parent(s)/legal guardian(s) are willing and able to comply with the study requirements and with the concomitant medication restrictions.

E.4

Principal exclusion criteria

1. Subject has a known genitourinary condition (other than NDO) that may cause overactive
contractions or incontinence (e.g., bladder extrophy, urinary tract obstruction, urethral
diverticulum or fistula) or kidney/bladder stones or another persistent urinary tract
pathology that may cause urinary symptoms.
2. Subject has one of following gastrointestinal problems: partial or complete obstruction, decreased motility such as paralytic ileus, subject at risk of gastric retention.
3. Subject has a urinary indwelling catheter within 4 weeks prior to visit 1/screening.
4. Subject has a surgically treated underactive urethral sphincter.
5. Subject has vesico-ureteral reflux grade 3 to 5.
6. Subject has undergone bladder augmentation surgery.
7. Subject receives electrostimulation therapy, if started within 30 days before visit 1/screening or is expected to start during the study period. Subjects who are on an established regimen may remain on this for the duration of the study.
8. Subject suffers from a symptomatic urinary tract infection (UTI) at baseline (symptomatic is defined as pain, fever, hematuria, new onset foul-smelling urine). If present at visit 1/screening or diagnosed between visit 1/screening and visit 3/baseline, the UTI should be treated successfully (clinical recovery) prior to baseline. If a symptomatic UTI is present at baseline, all baseline assessments are allowed to be postponed for a maximum of 7 days until the UTI is successfully treated (clinical recovery).
9. Subject has a (mean) resting pulse rate >99th percentile.
10. Subject has an established hypertension and systolic or diastolic blood pressure greater than the 99 th percentile of the normal range determined by sex, age, and height, plus mmHg.
11. Subject has a risk of QT prolongation (e.g., hypokalemia, long QT syndrome [LQTS]; or family history of LQTS, exercise-induced syncope).
12. Subject has severe renal impairment (estimated glomerular filtration rate [eGFR] according to Larsson equation < 30 mL/min).
13. Subject’s aspartate aminotransferase (AST) or alanine aminotransferase (ALT) is greater than or equal to 2 times the upper limit of normal (ULN) or total bilirubin greater than or equal to 1.5 times the ULN according to age and sex.
14. Subject has a history or presence of any malignancy prior to visit 1/screening.
15. Subject has known or suspected hypersensitivity to mirabegron, any of the excipients used in the current formulations or previous severe hypersensitivity to any drug.
16. Subject has participated in another clinical trial (and/or has taken an investigational drug within 30 days (or 5 half-lives of the drug, or the limit set by national law, whichever is longer) prior to visit 1/screening.
17. Subject uses any of the following prohibited medications (after start of washout):
• Any medication, other than the study drug, used for the management of NDO;
• Any drugs that are sensitive cytochrome (CYP) 2D6 substrates with a narrow therapeutic index or sensitive P-glycoprotein (P-gp) substrates
• Any strong cytochrome P450 (CYP) 3A4 inhibitors if the subject has a mild to moderate renal impairment (eGFR 30 – 89 mL/min).
18. Subject has been administered intravesical botulinum toxin; except if given > 4 months prior to visit 1/screening and the subject experiences symptoms comparable to those existing prior to the botulinum toxin injections.
19. Subject has any other condition, which in the opinion of the Investigator, precludes the subject’s participation in the study.
20. Subject’s parent/legal guardian is an employee of the Astellas Group, the Contract Research Organization (CRO) involved, or the investigator site executing the study.

E.5 End points

E.5.1

Primary end point(s)

Efficacy: Change from baseline in maximum cystometric capacity (MCC) after 24 weeks of treatment (based on filling urodynamics)

E.5.1.1

Timepoint(s) of evaluation of this end point

Efficacy: Visit 8, week 24 of efficacy treatment period

E.5.2

Secondary end point(s)

Efficacy
Based on filling urodynamics:
Change from baseline at visit 5/week 4 and visit 8/week 24 in:
• MCC (only visit 5/week 4)
• Bladder compliance (∆V/∆P)
• Number of overactive detrusor contractions (> 15 cm H20) until end of filling
• Detrusor pressure at end of filling
• Filling volume until first overactive detrusor contraction (> 15 cm H20)
Based on e-diary:
Change from baseline at visit 4/week 2, visit 5/week 4, visit 6/week 8, visit 7/week 12, visit 8/week 24, visit 9/week 36 and visit 10/ week 52 (EOT/EOS) in:
• Average catheterized volume per catheterization
• Maximum catheterized volume
• Maximum catheterized daytime volume
• Average morning catheterized volume (based on first catheterization after subject woke up)
• Mean number of leakage episodes per day (day and night time)
• Number of dry (leakage-free) days/7 days (day and night time)
Based on questionnaires:
• Change from baseline at visit 8/week 24 and visit 10/week 52 (EOT/EOS) in Pediatric Incontinence Questionnaire (PIN-Q)
• Change from baseline at visit 8/week 24 and visit 10/week 52 (EOT/EOS) in Patient Global Impression of Severity Scale (PGI-S)
• Acceptability questionnaire at visit 5/week 4, visit8/week 24 and visit 10/week 52 (EOT/EOS)
• Clinician Global Impression of Change (CGI-C) at visit 8/week 24 and visit 10/week 52 (EOT/EOS)
Safety
● Incidence and severity of treatment-emergent adverse events (TEAEs)
● Change from baseline in vital signs (clinic measurements): systolic blood pressure, diastolic blood pressure, pulse rate and temperature at visit 5/week 4, visit 7/week 12, visit 8/week 24 and visit 10/week 52 (EOT/EOS)
● Change from baseline in vital signs (self blood pressure measurement SBPM): systolic blood pressure, diastolic blood pressure, pulse rate at visit 4/week 2, visit 5/week 4, visit 6/week 8, visit 7/week 12, visit 8/week 24, visit 9/week 36 and visit 10/week 52 (EOT/EOS) and on 2 consecutive days at around 1 and 2 weeks after start of dosing with PED25 (day 1) and after up titration to PED50 (visit 4/week 2, visit 5/week 4 or visit 6/week 8), if not already covered by the scheduled visit 4/week 2 and/or visit 5/week 4 SBPM.
● Change from baseline in hematology and biochemistry tests at visit 7/week 12 and visit 10/week 52 (EOT/EOS) and urinalysis tests at visit 5/week 4, visit 7/week 12, visit 8/week 24 and visit 10/week 52 (EOT/EOS)
● Change from baseline in ECG parameters at visit 5/week 4 and visit 10/week 52 (EOT/EOS)
● Change from baseline to visit 10/week 52 (EOT/EOS) in upper urinary tract ultrasound assessment
● Change from baseline in eGFR at visit 7/week 12 and visit 10/week 52 (EOT/EOS)
Pharmacokinetic parameters will be determined at visit 5/week 4, visit 6/week 8, visit 7/week 12, visit 8/week 24 and/or visit 9/week 36: Cmax, tmax, AUC24, Ctrough, CL/F and Vz/F. Additional pharmacokinetic parameters may be calculated based on the model used.

E.5.2.1

Timepoint(s) of evaluation of this end point

For Efficacy and Safety end-points - See E.5.2
Pharmacokinetics: PK samples will be taken at 2 visits between visit 5/week 4 and visit 10/week 52 (EOT/EOS), when steady state has been reached

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

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

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

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

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Compared to parameter values at baseline

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

Australia

Belgium

Brazil

Colombia

Croatia

Denmark

Israel

Korea, Republic of

Latvia

Lithuania

Malaysia

Mexico

Norway

Philippines

Poland

Romania

Serbia

Singapore

Slovakia

Taiwan

Turkey

Jordan

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

The last subject’s last protocol-defined assessment will mark the end of the study.

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

Number of subjects for this age range:

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:

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

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

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

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)

None

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

2016-04-07

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-03-17

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2019-05-06

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Clinical trials