Clinical Trials Register

Summary
EudraCT Number:	2015-000538-31
Sponsor's Protocol Code Number:	Neuroimpa2015
National Competent Authority:	Germany - BfArM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2015-04-07
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

Germany - BfArM

A.2

EudraCT number

2015-000538-31

A.3

Full title of the trial

NEUORIMPA - Intraarticular Application of Opioids in Chronic Arthritis of the knee joint

NEUORIMPA - Intraartikuläre Applikation von Opioiden bei chronischer Arthritis des Kniegelenks

A.3.1

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

Application into the joint of opioids in chronic arthritis of the knee joint

Injektion von Morphin ins Kniegelenk bei Kniegelenksarthritis

A.3.2

Name or abbreviated title of the trial where available

Neuroimpa - knee joint

Neuroimpa- Kniegelenk

A.4.1

Sponsor's protocol code number

Neuroimpa2015

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	Charité University medicine Berlin
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	Bundesministerium für Bildung und Forschung
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	Charité Campus Benjamin Franklin Department of Rheumatology
B.5.2	Functional name of contact point	Trial Coordinator
B.5.3	Address:
B.5.3.1	Street Address	Hindenburgdamm 30
B.5.3.2	Town/ city	Berlin
B.5.3.3	Post code	12203
B.5.3.4	Country	Germany
B.5.4	Telephone number	+493084454414
B.5.5	Fax number	+493084454149
B.5.6	E-mail	hildrun.haibel@charite.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.2.1.1.1	Trade name	Morphine Hexal
D.2.1.1.2	Name of the Marketing Authorisation holder	Hexal
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 injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intraarticular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Morphinsulfat
D.3.9.3	Other descriptive name	MORPHINE SULFATE
D.3.9.4	EV Substance Code	SUB14597MIG
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
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	Triam 40 mg Lichtenstein
D.2.1.1.2	Name of the Marketing Authorisation holder	Lichtenstein
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	Suspension for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intraarticular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	TRIAMCINOLONACETONID
D.3.9.3	Other descriptive name	TRIAMCINOLONACETONID EP
D.3.9.4	EV Substance Code	SUB41525
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	40
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	Injection
D.8.4	Route of administration of the placebo	Intraarticular use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

chronic arthritis of the knee joint effusion as part of spondyloarthritis (Assessments in SpondyloArthritis international Society, ASAS criteria), Rheumatoid Arthritis, RA (according to American Col-lege of Rheumatology, ACR criteria), undifferentiated mono- or oligoarthritis, Osteoarthritis of the knee, OA.

Kniegelenksarthritis im Rahmen einer Spondyloarthritis (ASAS Kriterien), Rheumatoid Arthritis (ACR Kriterien) unidfferenzierten Mono- oder Oligoarthritis, Gonarthrose

E.1.1.1

Medical condition in easily understood language

Gonarthritis as part of spodyloarthritis, rheumatoid arthritis, undifferentiated arthritis of one or more than one joints, osteoarthritis

Kniegelenkentzündung im Rahmen einer Spondyloarthrits, rheumatoiden Arthritis, undifferenzierten Arthris eines oder mehrerer Gelenke, Kniegelenksarthrose

E.1.1.2

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	18.0
E.1.2	Level	LLT
E.1.2	Classification code	10067624
E.1.2	Term	Knee arthritis
E.1.2	System Organ Class	100000004859

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 pain and inflammatory parameters (cytokines, immune cells) in knee joint tissue of chronic arthritis pa-tients following intraarticular (i.a.) injections of morphine, a standard steroid or placebo.
The primary hypothesis is that i.a. morphine results in sig-nificantly lower pain scores and supplemental analgesic consumption than placebo during the first week after injec-tion, an efficacy comparable to standard i.a. steroid (tri-amcinolone) medication.
Primary efficacy endpoint:
Reduction of pain intensity (on a 100mm VAS) at 8 a.m. on day 7 compared to baseline.

Es werden Schmerz und Entzündungsparameter (Zytokine, Immunzellen) von Synovialgewebe des Kniegelenks bei Patienten mit chronischer Kniegelenkgsarthritis nach intra-artikulärer (i.a.) Applikation von Morphin, Triamcinolon oder Placebo untersucht.
Die primäre Hypothese ist, dass in der ersten Woche nach lokaler Injektion durch i.a. Morphin ins Kniegelenk eine signifikante Schmerzreduktion (NRS Schmerz) und Reduk-tion der zusätzlichen Schmerztherapie im Vergleich zu Pla-cebo eintritt, ähnlich effektiv wie die Standardtherapie mit einem intraartikulären Steroid (Triamcinolon).
Primärer Effektivitätsendpunkt:
Schmerzreduktion auf einer 10 Punkte NRS um 8 Uhr mor-gens an Tag 7 im Vergleich zu Baseline

E.2.2

Secondary objectives of the trial

Key secondary endpoint(s):
Area under the VAS curve (AUC) during the first week until 8 p.m. on day 7. Pain intensity on McGill pain questionnaire (MPQ); daily activities; activity and mobility of the knee joint (Lysholm Gilquist-Score); WOMAC scale (before i.a. injec-tions and at the end of each week). Inflammatory parame-ters (cellular infiltrate, opioid receptors and peptides, IL-17, TNFα) in synovial biopsies and fluid (before and 7 days af-ter i.a. medication), supplementary analgesic consumption.
Assessment of safety:
Any systemic (e.g. nausea, sedation) and local side effects (infection, tissue injury) will be recorded.

Wesentliche sekundäre Endpunkte:
Area under the curve (AUC) während der ersten Woche bis 8 Uhr morgens an Tag 7 nach Baseline. Schmerzintensität anhand des McGill Schmerzfragebogens (MPQ); tägliche Aktivitäten, Aktivität und Mobilität des Kniegelenk (Lysholm Gilquist-Score); WOMAC Skala (vor der i.a. Injektion und am Ende von Woche 1 und 2). Entzündungsparameter (Zellin-filtrat, Opioidrezeptoren und Peptide, IL17, TNFα) in Syno-vialbiopsien und –flüssigkeit vor und 7 Tage nach der i.a. Medikation, zusätzliche Einnahme von Schmerzmedikation
Sicherheitsassessments:
Jegliche Systemische (z.B. Übelkeit, Sedierung) und lokale Nebenwirkungen (z.B. Infektion, Gewebedefekte) werden erfasst.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Inclusion criteria:
1. Clinically detectable and/or ultrasound-visible knee ef-fusion as part of spondyloarthritis (Assessments in SpondyloArthritis international Society, ASAS criteria), Rheumatoid Arthritis, RA (according to American Col-lege of Rheumatology, ACR criteria), undifferentiated mono- or oligoarthritis, Osteoarthritis of the knee, OA.
2. baseline pain score (on a 100 mm Visual Analogue Scale, VAS) >40 mm;
3. male and female patients, age ≥18 - 80 years,
4. body weight 50 - 90 kg.
5. Able and willing to give a written informed consent and comply with the requirements of the study protocol.Only patients who give written informed consent will be included in the trial.
6. If female: either not of child-bearing potential (meno-pausal since 1 year or surgically sterile) or is willing and able to practice a reliable method of contraception throughout the study with a pearl index <1. Reliable methods of contraception are: condoms plus other methods: implants, injecatbles, combined oral contracep-tives, intrauterine devices, initiated at least 90 days prior to screening. Further reliable methods are a vasecto-mised partner (at least 1 year prior to enrolment), sexual-ly abstinent, surgically sterilized (including hysterecto-my), postmenopausal defined as at least 1 year of spon-taneous amenorrhea (in questionable cases a blood sample with simultaneous levels of follicle stimulating hormone (FSH) above 40 U/l and estradiol below 30 nl/l is confirmatory).
7. If male: either not of child-bearing potential (surgically sterilized, e.g. vasectomy) or is willing and able to prac-tice a reliable method of contraception with a pearl index <1 (see inclusion criterium 6) throughout the study.

Einschlusskriteiren:
1. Klinisch oder ultraschallgesteuert erkennbarer Kniege-lenkserguss im Rahmen einer Spondyloarthritis (ASAS Kriterien), RA (ACR Kriterien) unidfferenzierten Mono- oder Oligoarthritis, Gonarthrose.
2. Baseline VAS Schmerz Score (auf einer 100 mm visuel-len Analogskala) > 40 mm.
3. Männlich und weiblich, Alter 18 - 80 Jahre,
4. Gewicht 50 - 90 kg.
5. In der Lage und einverstanden, ein schriftliches Einver-ständnis zu geben sowie die Erfordernisse des Studi-enprotokolls einzuhalten. Nur Patienten, die ihre schriftliche Einwilligung gege-ben haben werden in die klinische Studie eingeschlossen.
6. Für Frauen: die Patientin ist entweder nicht gebärfähig oder willigt ein, eine effektive Kontrazeptionsmethode mit einem Pearlindex < 1 während der gesamten Studie anzuwenden. Zuverlässige Methoden sind: Kondom plus andere Methoden: implantierte, Injizierte, kombi-nierte orale Kontrazeptiva, Intrauterinpessar, begonnen mindestens 90 Tage vor Baseline, vasektomierter Part-ner (mindestens 1 Jahr vor Baseline), abstinent, chirur-gisch sterilisiert inclusive Hysterektomie, post-menopausal definiert als mindestens 1 Jahr vor Baseli-ne Amenorrhoe (in fraglichen Fällen Blutergebnis mit gleichzeitig vorliegendem FSH über 40 U/l und Estradiol < 30 nl/l zur Bestätigung).
7. Für Männer: der Patient ist entweder nicht zeugungsfä-hig oder willigt ein eine effektive Kontrazeptionsmetho-de mit einem Pearlindex <1 während der gesamten Stu-die anzuwenden.

E.4

Principal exclusion criteria

Exclusion criteria:
1. Severe cardiovascular, respiratory, metabolic, neurologi-cal, psychiatric disorders; current bacterial infection es-pecially of the knee
2. abuse of analgesics, benzodiazepines, alcohol; “hard drugs”
3. pregnancy, lactation
4. before biopsy thrombocyte count < 100/nl, Quick <50%
5. intake of anticoagulants, anti-aggregants as monothera-py such as ASS 100 will be allowed
6. participation in an investigational trial during the last 30 days or 5 HLT whichever is longer
7. treatment with intraarticular steroids during the past 4 weeks in the selected joint.
8. Patients with a history of a severe psychiatric illness, which might interfere with the patient's ability to under-stand the requirements of the study and assessment.
9. Patients who are institutionalised due to regulatory or juridical order. Patients who are an employee of the in-vestigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator.
10. Known hypersensitivity to any component of the study medication to morphine or triamcinolone, ileus, respira-tory depression, severe chronic obstructive airway dis-eases, acute abdomen, coagulopathy and/ or infections of the injection site, instability of the injected joint, psori-atic skin manifestation at the injection site, periarticular calcification, non-vascularized bone necrosis, tendon rupture, Charcot-joint.

Ausschlusskritieren:
1. Schwerwiegende kardiovaskuläre, respiratorische, me-tabolische, neurologische, psychiatrische Erkrankun-gen, aktuelle bakterielle Infektion insbesondere des Kniegelenks.
2. Missbrauch von Analgetika, Benzodiazepinen, Alkohol.
3. Schwangerschaft
4. Vor der Synovialbiopsie: Thrombocyten < 100/nl, Quick <50%
5. Einnahme von Antikoagulantien. Antiaggregation als Monotheraie wie z.B. ASS 100 ist erlaubt
6. Teilnahme an einer anderen Arzneimittelstudie inner-halb der letzen 30 Tage oder innerhalb von 5 HWZ des vorangegangenen Studienmedikaments, was immer länger ist.
7. Therapie mit intraartikulären Steroiden innerhalb der letzten 4 Wochen in das ausgewählte Gelenk.
8. Jeder andere Umstand, der den Patienten nach Mei-nung des Prüfarztes für die Studie ungeeignet macht.
9. Behördlich oder gerichtlich angeordnet institutionalisier-te Patienten. Patienten, die Angestellte des Prüfarztes oder des Prüfzentrums mit direkter Einbeziehung in die Studie oder andere Studien unter der Leitung des Prüfarztes, sowie Familienmitglieder des Prüfarztes oder des Arbeitgebers.
10. Bekannte Hypersensitivität gegenüber Komponenten der Studienmedikation Morphin oder Triamcinolon. Ileus, Atemdepression, schwere COPD, akutes Abdo-men, Koagulopathie und/ oder Infektionen der Injekti-onsstelle, Instabilität des zu injizierenden Ge-lenks,Psoriasisläsion an der Injektionsstelle, periartiku-läre Kalzifizierung, nicht vaskularisierte Knochennekro-se, Sehnenruptur, Charcot-Gelenk.

E.5 End points

E.5.1

Primary end point(s)

Primary efficacy endpoint:
Reduction of pain intensity (on a 100mm VAS) at 8 a.m. on day 7 compared to baseline.

Primärer Effektivitätsendpunkt:
Schmerzreduktion auf einer 10 Punkte NRS um 8 Uhr mor-gens an Tag 7 im Vergleich zu Baseline

E.5.1.1

Timepoint(s) of evaluation of this end point

week 1

Woche 1

E.5.2

Secondary end point(s)

Area under the VAS curve (AUC) during the first week until 8 p.m. on day 7. Pain intensity on McGill pain questionnaire (MPQ); daily activities; activity and mobility of the knee joint (Lysholm Gilquist-Score); WOMAC scale (before i.a. injec-tions and at the end of each week). Inflammatory parame-ters (cellular infiltrate, opioid receptors and peptides, IL-17, TNFα) in synovial biopsies and fluid (before and 7 days af-ter i.a. medication), supplementary analgesic consumption.
Assessment of safety:
Any systemic (e.g. nausea, sedation) and local side effects (infection, tissue injury) will be recorded.

Area under the curve (AUC) während der ersten Woche bis 8 Uhr morgens an Tag 7 nach Baseline. Schmerzintensität anhand des McGill Schmerzfragebogens (MPQ); tägliche Aktivitäten, Aktivität und Mobilität des Kniegelenk (Lysholm Gilquist-Score); WOMAC Skala (vor der i.a. Injektion und am Ende von Woche 1 und 2). Entzündungsparameter (Zellin-filtrat, Opioidrezeptoren und Peptide, IL17, TNFα) in Syno-vialbiopsien und –flüssigkeit vor und 7 Tage nach der i.a. Medikation, zusätzliche Einnahme von Schmerzmedikation
Sicherheitsassessments:
Jegliche Systemische (z.B. Übelkeit, Sedierung) und lokale Nebenwirkungen (z.B. Infektion, Gewebedefekte) werden erfasst.

E.5.2.1

Timepoint(s) of evaluation of this end point

week 1, week 2, safety follow up week 3

Woche 1, Woche 2, Sicherheits Follow Up Woche 3

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

Yes

E.6.13.1

Other scope of the trial description

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

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

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

The end of the trial is the last visit of the last subject.

Studienende ist, wenn der letzte Patient die letzte Visite durchlaufen hat.

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

F.3.3.1

Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2015-04-07.

Yes

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.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 trial the patients undergo standard care.

Nach der Studie warden die Patienten nach klinischem Standard weiterbehandelt.

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

2015-06-01

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-06-01

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2021-08-27

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