Clinical Trials Register

Summary
EudraCT Number:	2017-000868-15
Sponsor's Protocol Code Number:	P001151
National Competent Authority:	Germany - BfArM
Clinical Trial Type:	EEA CTA
Trial Status:	Trial now transitioned
Date on which this record was first entered in the EudraCT database:	2017-06-14
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Germany - BfArM

A.2

EudraCT number

2017-000868-15

A.3

Full title of the trial

Stereotactic Cisternal Lavage in Patients with Aneurysmal Subarachnoid Hemorrhage with Urokinase and Nimodipine for the Prevention of Secondary Brain Injury. A Randomized Controlled Trial.

Stereotaktische Zisternen-Lavage bei Patienten mit aneurysmatischer Subarachnoidalblutung mit Urokinase und Nimopidin zur Prävention sekundärer Hirnschädigung. Eine randomisierte kontrollierte Studie

A.3.1

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

Stereotactic Cisternal Lavage in Patients with Aneurysmal Subarachnoid Hemorrhage with Urokinase and Nimodipine for the Prevention of Secondary Brain Injury. A Randomized Controlled Trial

A.3.2

Name or abbreviated title of the trial where available

SPLASH

A.4.1

Sponsor's protocol code number

P001151

A.5.4

Other Identifiers

Name:

Internal project no.

Number:

P001151

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	Medical Center -University of Freiburg
B.1.3.4	Country	Germany
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Else Kröner-Fresenius-Stiftung
B.4.2	Country	Germany
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Universitätsklinikum Freiburg
B.5.2	Functional name of contact point	Coordinating Investigator
B.5.3	Address:
B.5.3.1	Street Address	Breisacher Str. 64
B.5.3.2	Town/ city	Freiburg
B.5.3.3	Post code	79106
B.5.3.4	Country	Germany
B.5.4	Telephone number	+49 76127050940
B.5.5	Fax number	+4976127050100
B.5.6	E-mail	roland.roelz@uniklinik-freiburg.de

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.2.1.2	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	Solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intrathecal 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/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10 mg/50 ml
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.2.1.2	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	Powder for solution for injection/infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intrathecal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Urokinase
D.3.9.1	CAS number	9039-53-6
D.3.9.3	Other descriptive name	UROKINASE
D.3.9.4	EV Substance Code	SUB05055MIG
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	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	Yes
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	Solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intrathecal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Calciumchlorid-Dihydrat
D.3.9.1	CAS number	8026-10-6
D.3.9.3	Other descriptive name	RINGER'S SOLUTION
D.3.9.4	EV Substance Code	SUB33359
D.3.10	Strength
D.3.10.1	Concentration unit	g/l gram(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0,33
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Kaliumchlorid
D.3.9.1	CAS number	8026-10-6
D.3.9.3	Other descriptive name	RINGER'S SOLUTION
D.3.9.4	EV Substance Code	SUB33359
D.3.10	Strength
D.3.10.1	Concentration unit	g/l gram(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0,3
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Natriumchlorid
D.3.9.1	CAS number	8026-10-6
D.3.9.3	Other descriptive name	RINGER'S SOLUTION
D.3.9.4	EV Substance Code	SUB33359
D.3.10	Strength
D.3.10.1	Concentration unit	g/l gram(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	8,6
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

Aneurysmal Subarachnoid Hemorrhage (aSAH)

Aneurysmatische Subarachnoidalblutung (aSAB)

E.1.1.1

Medical condition in easily understood language

Bleeding caused by rupture of a cerebral aneurysma

Durch den Riss einer Aussackung eines Hirngefäßes entstehende Blutung

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	20.1
E.1.2	Level	LLT
E.1.2	Classification code	10042320
E.1.2	Term	Subarachnoid hemorrhage
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 assess whether cisternal lavage therapy with Urokinase, Ringer's solution and Nimodipine administered via a stereotactically implanted catheter into the prepontine cistern (IT, Investigational Treatment) improves neurological outcome and is safe in patients with aSAH.

Untersuchung, ob eine Zisternen-Lavagetherapie mit Urokinase, Ringerlösung und Nimodipin über einen stereotaktischen Katheter in die basalen Zisternen (=Prüftherapie) das neurologische Outcome von Patienten mit aSAB verbessert und ob diese Anwendung sicher ist.

E.2.2

Secondary objectives of the trial

To assess whether cisternal lavage therapy with Urokinase and Nimodipine administered via a stereotactically implanted catheter into the prepontine cistern (IT, Investigational Treatment) improves neurological outcome and is safe in patients with aSAH.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Male or female patients aged ≥18 years and <80 years
2. Modified Fisher grade 3 or 42
3. Cisternal/Ventricular blood amount according to Hijdra Score ≥ 203
4. Admission WFNS grade ≥ 3 (if grade 5 only with fixed dilated pupil due to raised ICP for less than 45 minutes)
5. External ventricular drain (EVD) in situ or indication for placement of EVD
6. Disease duration ≤96 hours before randomization
7. Written informed consent, either by patient or by patient’s legally authorized representative
8. Cerebral aneurysm as definitive source of subarachnoid hemorrhage
9. Patients in whom the cerebral aneurysm has been safely treated via open surgical or endovascular technique.

1) Männliche oder weibliche Patienten ≥ 18 Jahre und <80 Jahre
2) Modifizierter Fisher Grad 3 oder 4
3) Zisternale/ventrikuläre Blutmenge mit einem Hijdra Score ≥ 20
4) WFNS Grad ≥ 3 bei Aufnahme (bei Grad 5 nur bei weniger als 45 Minuten bestehenden weiten Pupillen durch den erhöhten Hirndruck)
5) Vorhandensein einer oder Indikation für die Anlage einer externen Ventrikeldrainage
6) Dauer der Erkrankung ≤96 Stunden vor Randomisierung
7) Schriftlich erteilte Einwilligung, entweder durch den Patienten selbst oder durch den gesetzlichen Vertreter
8) Zerebrales Aneurysma als gesicherte Ursache der Subarachnoidalblutung
9) Erfolgte Behandlung des zerebralen Aneurysmas mittels offener chirurgischer oder endovaskulärer Verfahren

E.4

Principal exclusion criteria

1. Pregnancy
2. Surgical contraindications according to the opinion of the investigator
3. Inability to administer study medication (known allergy to urokinase or nimodipine)
4. Presence of a severe illness prior to aSAH (e.g. progressive cancer, terminal organ failure, severe neurological disorder, life expectancy < 1 year)
5. Known and persistent abuse of medication or drugs
6. Presence of severe cerebral infarction related to the aSAH or medical procedures prior to randomization
7. Presence of intracerebral hematoma that is ≥ 30ml (assessed using the AxBxC/2 method)5 or in eloquent location prior to randomization
8. Presence of a condition or abnormality that in the opinion of the Investigator would compromise safety of the patient
9. Known severe complications during aneurysm securing (e.g. dissections of blood vessels, vessel occlusions, re-hemorrhage)
10. Clinical signs of brain stem / midbrain compression (dilated pupil not reacting to light) persisting for more than 45 minutes at any time between aSAH onset and randomization
11. Persons who are in a relationship of dependence/employment with the sponsor or the investigator
12. For MRI follow-up: cardiac pacemaker and/or cardiac defibrillator. Stent implantation within the last 6 weeks prior to MRI, claustrophobia

1) Schwangerschaft, stillende Frauen
2) Chirurgische Kontraindikationen nach Einschätzung des Prüfarztes
3) Applikation der Studienmedikation nicht möglich (z.B. bekannte Allergie gegen Urokinase oder Nimodipin)
4) Vorliegen einer schweren Erkrankung vor der aSAB (z.B. fortgeschrittenes Tumorleiden, terminales Organversagen, schwerwiegende neurologische Erkrankung)
5) Bekannter und fortgesetzter Medikamenten- oder Drogenabusus
6) Vorliegen eines akuten, ausgedehnten zerebralen Infarkts mit Bezug zur aSAB oder zu medizinischen Prozeduren vor Randomisierung
7) Vorliegen einer intrazerebralen Blutung ≥ 30 ml (nach AxBxC/2-Methode) oder in eloquenter Lage vor Randomisierung
8) Vorliegen eines Zustands, der nach Einschätzung des Prüfarztes die Sicherheit des Patienten beeinträchtigen würde
9) Schwere Komplikationen während der Aneurysmasicherung (z.B. Gefäßdissektionen oder -verschlüsse, erneute Blutung)
10) Klinische Zeichen einer Hirnstamm-/Mittelhirnkompression (lichtstarre Pupille) für mehr als 45 Minuten zwischen dem Beginn der aSAB und der Randomisierung
11) Personen, die sich in einem Abhängigkeits-/Arbeitsverhältnis zum Sponsor oder Prüfer befinden
12) Für das MRT während der Nachbeobachtung: Herzschrittmacher und/oder Defibrillator, Stentimplantation innerhalb der letzten 6 Wochen vor MRT, Klaustrophobie

E.5 End points

E.5.1

Primary end point(s)

Neurological outcome: Proportion of subjects with a favorable outcome measured on the modified Rankin Scale (mRS) at 6months after aSAH, assessed by an independent physician. mRS will be analyzed in a dichotomized fashion:
favorable, defined as: mRS 0-3 (independent)
vs.
unfavorable, defined as: mRS 4-6 (dependent/dead)

Neurologisches Outcome: Anteil der Patienten mit einem günstigen Outcome, gemessen auf der modifizierten Rankin-Skala (mRS) und erhoben von einem unabhängigen Arzt zum Zeitpunkt 6 Monate nach aSAB. mRS wird dichotom analysiert:
günstig, definiert als: mRS 0-3 (unabhängig)
vs.
ungünstig, definiert als: mRS 4-6 (abhängig/verstorben)

E.5.1.1

Timepoint(s) of evaluation of this end point

6 months after aSAH

6 Monate nach Auftreten der aSAB

E.5.2

Secondary end point(s)

- mRS at 12 months after aSAH
- Neuropsychological outcome
-- Cognitive performance (Montreal Cognitive Assessment) at 6 months following aSAH
-- Health-related quality of life (SF-36) at 6 months
-- Fatigue, anxiety and depressive symptoms (Frontal Systems Behavior Scale, Multidimensional Assessment of Fatigue, Hospital Anxiety and Depression Scale), Post-traumatic stress disorder (Impact of Event Scale – R) at 6 months
-- Return-to-work parameters at 6 and 12 months
- Rate and severity of delayed cerebral infarction (DCI) according to the Vergouwen criteria
- Rate of delayed ischemic neurological deficit (DIND), defined as clinical deterioration caused by delayed cerebral ischemia (i.e. a new focal neurological deficit or decline on the Glasgow Coma Scale of 1 point not attributable to other causes) on days 3 – 21. (Note: The date of aSAH occurrence is defined as day 0.)
- Delta mean flow velocities of both middle cerebral arteries – measured by transcranial Doppler-ultrasonography on days 3 – 15.
- NIHSS score at day 32 and at 6 months
- Rates of shunt-dependent hydrocephalus at 6 months following aSAH
- Rate of endovascular interventions for the treatment of cerebral vasospasm
- Key parameters of endocrinological dysfunction
- Morphological brain damage at 6 months after aSAH as assessed by MRI
- Key markers of neuronal injury and systemic inflammation in patient blood
- electroencephalographic patterns as measured by continuous EEG-monitoring during intensive care period (exploratory endpoint)
- Safety of IT: (Serious) Adverse Events related to the IT

- mRS 12 Monate nach aSAB
- Neuropsychologisches Outcome
-- Kognitive Leistungsfähigkeit (Montreal Cognitive Assessment) 6 Monate nach aSAB
-- Gesundheitsbezogene Lebensqualität (SF-36) nach 6 Monaten
-- Müdigkeit, Ängstlichkeit und depressive Symptome (Frontal Systems Behavior Scale, Multidimensional Assessment of Fatigue, Hospital Anxiety and Depression Scale), posttraumatische Belastungsstörung (Impact of Event Scale - R) nach 6 Monaten
-- Parameter zur Arbeitsfähigkeit nach 6 und 12 Monaten
- Rate und Schweregrad verzögerter Hirninfarkte (DCI) nach den Vergouwen-Kriterien
- Rate verzögerter ischämischer neurologischer Defizite (DIND), definiert als klinische Verschlechterung durch verzögerte zerebrale Ischämie (d.h. ein neues fokales neurologisches Defizit oder Rückgang auf der Glasgow Coma-Skala von 1 Punkt, der nicht auf andere Ursachen zurückzuführen ist) an den Tagen 3 - 21. (Hinweis: Das Datum des Auftretens von aSAB ist definiert als Tag 0.)
- Delta mittlerer Strömungsgeschwindigkeiten beider mittleren Hirnarterien, gemessen mittels transkranieller Doppler-Sonografie an den Tagen 3 - 15
- NIHSS-Wert an Tag 32 und nach 6 Monaten
- Anteil von Patienten mit shunt-pflichtigen Hydrocephalus 6 Monate nach aSAH
- Rate endovaskulärer Interventionen zur Behandlung des zerebralen Vasospasmus
- Schlüsselparameter der endokrinologischen Dysfunktion
- Morphologische Hirnschäden 6 Monate nach aSAB, erhoben mittels MRT
- Marker für neuronale Schädigung und systemische Inflammation im Patientenblut
- Elektroenzephalografisches Bild im kontinuierlichen EEG-Monitoring während der intensivstationären Behandlung (explorativer Endpunkt)
- Sicherheit der Prüftherapie: (Schwerwiegende) unerwünschte Ereignisse im Zusammenhang mit der Prüftherapie

E.5.2.1

Timepoint(s) of evaluation of this end point

Timepoints of evaluations are included in the description of the respective endpoints

Zeitpunkte sind in der Beschreibung der Endpunkte enthalten

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

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)

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

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

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)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Behandlung der aSAB gemäß europäischer Leitlinien

Treatment of aSAH according to European guidelines

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.5

The trial involves multiple Member States

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

Letzter Besuch des letzten Patienten

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

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

Aneurysmatic subarachnoid hemorrhage is a life-threatening disease. Patients may suffer from deterioration and impaired consciousness and may therefore not be able to give informed consent.

Die aneurysmatische Subarachnoidalblutung ist eine lebensbedrohliche Erkrankung. Die Patienten leiden unter Bewusstseinsstörungen und können daher möglicherweise nicht selbst in die Studienteilnahme einwilligen.

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)

After end of the intrathecal treatment, continuation of medication and further treatments is at the discretion of the treating physician. Imaging follow-up after end of the trial (e.g. for long-term aneurysm surveillance) will be performed according to the trial site’s routine.

Nach Beendigung der intrathekalen Applikation von Medikamenten wird die weitere Behandlung nach Meinung des behandelnden Arztes durchgeführt. Die Bildgebung (z.B. zur Langzeitnachbeobachtung des Aneurysmas) wird entsprechenden den lokalen Standards durchgeführt.

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

2019-01-03

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-01-15

P. End of Trial
P.	End of Trial Status	Trial now transitioned

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IMP with orphan designation in the indication
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