Clinical Trials Register

Summary
EudraCT Number:	2016-004521-17
Sponsor's Protocol Code Number:	BIT-001
National Competent Authority:	Austria - BASG
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2017-12-06
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

Austria - BASG

A.2

EudraCT number

2016-004521-17

A.3

Full title of the trial

A Phase IIa: single ascending dose safety, tolerability and pharmacokinetic study of NicaPlant® in aneurysmal subarachnoid haemorrhage patients undergoing aneurysm clipping

Eine Phase IIa: ansteigende Einfachdosierungprüfung zur Evaluierung der Sicherheit, Verträglichkeit und Pharmakokinetik von NicaPlant® an aneurysmatischen Subarachnoidalblutungspatienten mit Aneurysmaclipping-Operation

A.3.1

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

A clinical study performed with increasing doses (single dose per patient) to evaluate safety, tolerability and pharmacokinetic of NicaPlant® in aneurysmal subarachnoid haemorrhage patients needing to undergo an aneurysm clipping operation

Eine klinische Studie, die mit ansteigenden Dosen (eine Dose pro Patient) durchgeführt wird um die Sicherheit, Verträglichkeit und Pharmakokinetik von NicaPlant® bei aneurysmatischen Subarachnoidalblutungspatienten mit Aneurysmaclipping-Operation festzustellen

A.4.1

Sponsor's protocol code number

BIT-001

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	BIT Pharma GmbH
B.1.3.4	Country	Austria
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	BIT Pharma GmbH
B.4.2	Country	Austria
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	NeuroScios GmbH
B.5.2	Functional name of contact point	CRO
B.5.3	Address:
B.5.3.1	Street Address	Willersdorferstrasse 7
B.5.3.2	Town/ city	St. Radegund
B.5.3.3	Post code	8061
B.5.3.4	Country	Austria
B.5.4	Telephone number	004331324044412
B.5.5	Fax number	004331324044420
B.5.6	E-mail	nhelmberg@neuroscios.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	NicaPlant®
D.3.4	Pharmaceutical form	Implant
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Implantation
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	NICARDIPINE
D.3.9.1	CAS number	55985-32-5
D.3.9.4	EV Substance Code	SUB09225MIG
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	4
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	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	Nimodipin HEXAL® 30 mg (Dihydropyridine calcium channel blocker)
D.2.1.1.2	Name of the Marketing Authorisation holder	Hexal AG
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	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	NIMODIPINE
D.3.9.1	CAS number	66085-59-4
D.3.9.4	EV Substance Code	SUB09297MIG
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	30
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	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

Aneurysmal subarachnoid haemorrhage

Aneurysmatische Subarachnoidalblutung

E.1.1.1

Medical condition in easily understood language

Aneurysmal subarachnoid haemorrhage

Aneurysmatische Subarachnoidalblutung

E.1.1.2

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.1
E.1.2	Level	PT
E.1.2	Classification code	10008111
E.1.2	Term	Cerebral haemorrhage
E.1.2	System Organ Class	10029205 - Nervous system 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

To investigate the safety and tolerability of single ascending doses (as number of implants/patient) of local nicardipine application via polymers (NicaPlant®).

Die Untersuchung der Sicherheit und Verträglichkeit von ansteigenden Einfachdosierungen (Anzahl der Implantate/Patient) von lokal applizierten Nicardipinpolymeren (NicaPlant®).

E.2.2

Secondary objectives of the trial

• To assess the pharmacokinetics of single ascending doses (as number of implants/patient) of NicaPlant® in Plasma, and its levels in CSF.
• To take exploratory measurements of clinical efficacy in terms of:
o Incidence of moderate or severe cerebral angiographic vasospasm assessed by digital subtraction angiography (DSA) at 8±1 days after aneurysm rupture.
o Incidence of vasospasm-related morbidity/mortality within 14 days post-aneurysm rupture.
o Incidence of new cerebral infarcts on computed tomography (CT) scan performed at day 14 post-aneurysm rupture versus post-treatment CT scan.

• Die Messung der Pharmacokinetik von ansteigenden Einfachdosierungen (Anzahl der Implantate/Patient) von NicaPlant® und die Messung des Spiegels in CSF.
• Die explorative Messung der klinischen Wirksamkeit in Form von:
o Inzidenz von mäßigen oder schweren zerebralen angiographischen Vasospasmen gemessen durch digitale Subtraktionsangiographie (DSA) 8±1 Tage nach der Aneurysmaruptur.
o Inzidenz von mit Vasospasmen in Zusammenhang stehender Morbidität/Mortalität innerhalb 14 Tage nach der Aneurysmaruptur.
o Inzidenz von neuen Hirninfarkten gemessen durch Computertomographie am Tag 14 nach der Aneurysmaruptur verglichen mit der Nachbehandlungscomputertomographie.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Informed consent is obtained.
2. Male or female patients aged 18 to 75 years (inclusive).
3. Federation of Neurosurgery (WFNS) grade I-IV or Hunt & Hess grade I-IV.
4. Ruptured saccular aneurysm, confirmed by angiography.
5. Onset of aSAH clinical symptoms within the preceding 48 hours.
6. Treatment of aneurysm via surgical clip ligation within 72 hours of aSAH is achievable.
7. Female patients of child-bearing potential must have a negative pregnancy test (urine or serum) at screening and must agree to use adequate birth control during the study and up to 2 months after implantation of the study drug. Female patients are considered to be not of child-bearing potential if they have a history of tubal ligation or hysterectomy or are post-menopausal with a minimum of 2 years without a natural menstrual cycle. Male patients must agree to use adequate birth control during the study and up to 4 months after implantation of the study drug.

1. Einwilligung wurde eingeholt.
2. Männliche und weibliche Patienten zwischen 18 und einschließlich 75 Jahren alt.
3. Federation of Neurosurgery (WFNS) Grad I-IV oder Hunt & Hess Grad I-IV.
4. Rupturiertes sakkuläres Aneurysma , durch Angiographie bestätigt.
5. Beginn der klinischen Symptome innerhalb der vorangegangenen 48 Stunden.
6. Die Behandlung des Aneurysma ist chirurgisch innerhalb von 72 Stunden durchführbar.
7. Weibliche Patientinnen im gebärfähigen Alter müssen einen negativen Schwangerschaftstest (Urin oder Serum) beim Screening haben und müssen sich einverstanden erklären, eine angemessene Kontrazeptiva, während der Studie und bis zu 2 Monate nach der Implantation des Prüfpräparates, zu verwenden. Patientinnen gelten als nicht gebährfähig, wenn sie eine Hysterektomie hatten oder seit mindestens 2 Jahren postmenopausal sind. Männliche Patienten müssen sich einverstanden erklären angemessen zu verhüten, während der Studie und bis zu 4 Monate nach Implantation des Prüfpräparates.

E.4

Principal exclusion criteria

1. SAH due to other causes (e.g. trauma, fusiform or mycotic aneurysm).
2. Pregnant or lactating Women.
3. Federation of Neurosurgery (WFNS) grade V or Hunt & Hess grade V.
4. Intraventricular or intracerebral blood, in the absence of subarachnoid blood.
5. Treatment of aneurysm via endovascular embolization.
6. Presence of moderate or severe vasospasm on screening angiography.
7. Any known or CT evidence of previous major cerebral damage.
8. Evidence of a cerebral infarction with neurological deficit on pre-treatment CT.
9. History of malignant disease (except for non-melanoma skin cancer) within the previous 5 years or any history of malignant brain tumours or brain metastasis.
10. Patients who have received an investigational product or participated in another interventional clinical study within 30 days prior to randomisation.
11. Kidney disease as defined by plasma creatinine ≥2.5mg/dL (221µmol/L); liver disease as defined by total bilirubin >3mg/dL (513µmol/L); and/or known diagnosis or clinical suspicion of liver cirrhosis.
12. Patients with known allergy for Poly (D,L-lactide-co-glycolide) (PLGA) or nicardipine.
13. Major complication during aneurysm repair such as, but not limited to, massive intraoperative haemorrhage, brain swelling, or inability to secure the ruptured aneurysm.

1. Gehirnblutung aufgrund anderer Ursachen (Trauma, fusiformes oder mykotisches Aneurysma).
2. Schwangere oder stillende Frauen.
3. Federation of Neurosurgery (WFNS) Grad V oder Hunt & Hess Grad V.
4. Intraventrikuläres oder intracerebrales Blut, kein Subarachnoidalblut.
5. Behandlung des Aneurysma durch Gefäßkatheder.
6. Vorhandensein von moderaten oder schweren Vasospasmen in der Screeningangiografie.
7. Jegliche bekannte, oder durch CT festgestellte, vorherige cerebrale Schäden.
8. Nachweis eines zerebralen Infarktes mit neurologischen Defizit.
9. Maligne Erkrankungen (Ausnahmen Nicht-Melanom Hautkrebs) innerhalb der letzten 5 Jahre sowie maligne Hirntumore oder Hirnmetastasen in der Vergangenheit.
10. Teilnahme an einer anderen interventionellen klinischen Studie innerhalb der letzten 30 Tagen vor Randomisierung.
11. Nierenerkrankungen, definiert als Plasmakreatinin ≥ 2,5md/dl (221µmol/L); Lebererkrankungen, definiert als Gesamtbilirubin >3 mg/dl (513µmol/L); und/oder bekannte Diagnose oder klinischer Verdacht auf Leberzirrhose.
12. Patienten mit bekannter Allergie auf Poly (D, L-Lactid-co-glycolid) oder Nicardipin.
13. Starke Komplikationen bei der Aneurysmaoperation, wie, aber nicht ausschließlich, massive intraoperative Blutungen, Gehirnschwellung, oder Unvermögen das Aneurysma auf diese Art zu behandeln.

E.5 End points

E.5.1

Primary end point(s)

Safety:
• Adverse events (AEs)
• Occurrence of shunt-dependent hydrocephalus
• Occurrence of bacterial meningitis
• Change in grading of AE severity
• Vital Signs: blood pressure (BP), pulse rate, respiratory rate and body temperature
• Electrocardiogram (ECG)
• Full blood count, urea and electrolytes, liver function tests, C-reactive protein

Sicherheit:
• Unerwünschte Ereignisse (AEs)
• Auftreten von shuntabhängigem Hydrocephalus
• Auftreten von bakterieller Meningitis
• Änderung des AE-Schweregrades
• Vitalzeichen: Blutdruck, Puls, Atemfuntion und Körpertemperatur
• Elektrokardiogramm (EKG)
• großes Blutbild, Harnstoff und Elektrolyte, Leberfunktionstest, C-reaktives Protein

E.5.1.1

Timepoint(s) of evaluation of this end point

Safety assessments will be made from baseline until day 21±1, daily or on alternate days.

Sicherheitsbewertungen werden von der Baseline bis Tag 21±1, täglich oder an abwechselnden Tagen gemacht.

E.5.2

Secondary end point(s)

Exploratory endpoint
Incidence of moderate or severe cerebral angiographic vasospasm assessed by digital subtraction angiography (DSA) at 8±1 days after aneurysm rupture, where angiographic vasospasm is defined as a ≥33% reduction in diameter in at least one vessel segment by comparison to preoperative (and pre NicaPlant® implantation) angiography. The day 8±1 angiogram will be performed even if the patient has no clinical or sonographic evidence of vasospasm.

Other exploratory endpoints
1. Incidence of vasospasm-related morbidity/mortality within 21 days post-aneurysm rupture, defined by at least one of the following:
a. Delayed ischemic neurological deficit (DIND) – confirmed by mGCS.
b. Death caused by vasospasm, DIND, infarcts or complications due to anti-vasospasm therapy.
2. Incidence of new cerebral infarcts on CT scan performed at Day 14 ± 1 post-aneurysm rupture versus post-treatment CT scan.
3. The need for anti-vasospasm rescue therapy within 14 days post-aneurysm rupture.
4. Daily assessment of modified Glasgow Coma Scale (mGCS) up to Day 21.

Pharmacokinetics (PK):
Only samples collected in patients treated with NicaPlant® will be analysed at the end of this study.

Pharmacodynamics (PD):
The PD endpoints are angiographic measurements of cerebral vasospasm, DIND and new cerebral infarcts on CT scan.

Explorative Endpunkte
Inzidenz von moderaten oder schweren zerebralen angiographischen Vasospasmen gemessen durch digitale Subtraktionsangiographie (DSA), wobei angiographische Vasospasmen definiert sind durch eine ≥33% Reduktion des Durchmessers in zumindest einem Gefäßsegment im Vergleich zur präoperativen (und vor NicaPlant®-Implatation) Angiographie. Die 8±1 Tage Angiographie wird durchgeführt auch wenn der Patient keine klinischen oder sonographischen Anzeichen von Vasospasmen zeigt.

Andere explorative Endpunkte
1. Inzidenz von mit Vasospasmen in Zusammenhang stehender Morbidität/Mortalität innerhalb 21 Tage nach Aneurysmaruptur, definiert durch zumindest eines der folgenden:
a. Verzögerte ischämisch-neurologische Defizite (DIND) - bestätigt durch mGCS.
b. Tod durch Vasospasmus, DIND, Infarkte oder Komplikationen aufgrund der Antivasospasmustherapie.
2. Inzidenz von neuen Hirninfarkten gemessen durch Computertomographie 14 ± 1 Tage nach Aneurysmaruptur verglichen mit der Nachbehandlungscomputertomographie.
3. Die Notwendigkeit einer Antivasospasmusrettungstherapie innerhalb von 14 Tagen nach Aneurysmaruptur.
4. Bemessung des modifizierten Glasgow Coma Scale (mGCS) bis Tag 21.

Pharmakokinetik (PK):
Nur Proben von Patienten die mit NicaPlant® behandelt wurden werden am Ende der Studie analysiert.

Pharmakodynamik (PD):
Die PD-Endpunkte sind die angiographischen Bewertungen von zerebralen Vasospasmen, DIND und neue Hirninfarkten gemessen durch Computertomographie.

E.5.2.1

Timepoint(s) of evaluation of this end point

Exploratory endpoint
8±1 days after aneurysm rupture. If the patient develops clinical or sonographic changes suggestive of vasospasm prior to day 8, an angiogram will be performed and replaces the one scheduled at day 8±1.

Other exploratory endpoints
1. Within 21 days post-aneurysm rupture
2. Day 14 ± 1 post-aneurysm rupture
3. Within 14 days post-aneurysm rupture
4. Daily assessment up to Day 21

Pharmacokinetics (PK):
Blood sampling for PK assessment will be carried out on day of clip ligation, on day 8, day 14 and day 21 after aneurysm rupture;
single cerebrospinal fluid (CSF) samples obtained from patients provided for medical reasons of an external ventricular drain (EVD)/lumbar drain will be collected on alternate days up day 21 to determine nicardipine levels.

Explorative Endpunkte
8±1 Tage nach der Aneurysmaruptur. Wenn der Patient vor Tag 8 klinische oder sonographische Anzeichen von Vasospasmen zeigt, wird eine Angiographie durchgeführt/ersetzt die Angiographie von Tag 8±1.

Andere explorative Endpunkte
1. Innerhalb 21 Tage nach der Aneurysmaruptur
2. Tag 14 ± 1 nach der Aneurysmaruptur
3. Innerhalb 14 Tagen nach der Aneurysmaruptur
4. Tägliche Bemessungen bis einschließlich Tag 21

Pharmakokinetik (PK):
Blutabnahmen für PK werden am Tag des Clippings, am Tag 8, Tag 14 und Tag 21 nach der Aneurysmaruptur;
eine einzelne Zerebrospinalflüssigkeitsprobe wird von Patienten mit aus medizinischen Gründen externe ventrikuläre Drainage/Lumbardrainage an abwechselnden Tagen bis zu Tag 21 entnommen um Nicardipinlevels zu bestimmen.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

Yes

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

Yes

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)

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

E.8.6.2

Trial being conducted completely outside of the EEA

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

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 months

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:

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

Yes

F.3.3.6

Subjects incapable of giving consent personally

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Patients with aneurysmal subarachnoid haemorrhage may be unconscious or suffer under speech and comprehension impairment and can therefore not give informed consent.

Patienten mit aneurysmatischen Subarachnoidalblutungen können bewusstlos sein oder an einer Sprach- und Verständnisstörung leiden und können deshalb die Patienteninformation und die Einverständniserklärung nicht verstehen.

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

2018-02-19

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-12-07

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2019-01-09

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IMP with orphan designation in the indication
Orphan Designation Number:
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