Clinical Trials Register

Summary
EudraCT Number:	2018-002003-33
Sponsor's Protocol Code Number:	EQ06.17.01
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2021-01-29
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2018-002003-33

A.3

Full title of the trial

A double blind, double dummy, multicenter, randomized, placebo- and active-controlled clinical trial to evaluate effectiveness of Tricortin 1000 in patients affected by chronic low back pain

Studio clinico multicentrico, randomizzato, in doppio cieco,doppio dummy, controllato verso placebo e verso farmaco attivo, con lo scopo di valutare l'efficacia di Tricortin 1000 in pazienti affetti da LBP cronico

A.3.1

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

A placebo- and active-controlled clinical trial to evaluate effectiveness of Tricortin 1000 in patients with chronic low back pain

Studio controllato verso placebo e verso farmaco attivo, con lo scopo di valutare l'efficacia di Tricortin 1000 in pazienti affetti da LBP cronico

A.3.2

Name or abbreviated title of the trial where available

Effectiveness of Tricortin 1000 in chronic low back pain

Efficacia di Tricortin 1000 nel LBP cronico

A.4.1

Sponsor's protocol code number

EQ06.17.01

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	FIDIA FARMACEUTICI S.P.A.
B.1.3.4	Country	Italy
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	FIDIA FARMACEUTICI S.P.A.
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	LB Research S.r.l.
B.5.2	Functional name of contact point	Scientific Direction
B.5.3	Address:
B.5.3.1	Street Address	Via Lombardia 81
B.5.3.2	Town/ city	Cantù (CO)
B.5.3.3	Post code	22063
B.5.3.4	Country	Italy
B.5.4	Telephone number	0039031734908
B.5.5	Fax number	00390317372218
B.5.6	E-mail	flavia.baruzzi@lbresearch.it

D. IMP Identification
D.IMP: 1
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	ITAMI - 140 MG CEROTTO MEDICATO
D.2.1.1.2	Name of the Marketing Authorisation holder	FIDIA FARMACEUTICI S.P.A.
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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	Itami
D.3.2	Product code	[Itami]
D.3.4	Pharmaceutical form	Medicated plaster
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Topical use (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	DICLOFENAC SODICO
D.3.9.1	CAS number	15307-79-6
D.3.9.2	Current sponsor code	na
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	140
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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	TRICORTIN 1000 - 12 MG + 1 MG/2 ML SOLUZIONE INIETTABILE PER USO INTRAMUSCOLARE 5 FIALE 2 ML
D.2.1.1.2	Name of the Marketing Authorisation holder	FIDIA FARMACEUTICI S.P.A.
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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	Tricortin 1000
D.3.2	Product code	[Tricortin 1000]
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	Intramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	FOSFOLIPIDI TOTALI
D.3.9.2	Current sponsor code	na
D.3.9.3	Other descriptive name	PHOSPHOLIPIDS FROM SWINE CERBELLAR CORTEX
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	6
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	CIANOCOBALAMINA
D.3.9.1	CAS number	68-19-9
D.3.9.2	Current sponsor code	na
D.3.9.3	Other descriptive name	Cyanocobalamin
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	500
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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	Yes
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	Solution for injection
D.8.4	Route of administration of the placebo	Intramuscular use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Medicated plaster
D.8.4	Route of administration of the placebo	Topical use (Noncurrent)

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Low Back Pain

Lombalgia, lombocruralgia, lombosciatalgia

E.1.1.1

Medical condition in easily understood language

Pain involving muscles, nerves and bones of the low back

Dolore ai muscoli, nervi e ossa della parte bassa della schiena

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	21.0
E.1.2	Level	LLT
E.1.2	Classification code	10052430
E.1.2	Term	Chronic lumbago
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 demonstrate superiority of Tricortin 1000 over placebo in improvement in pain relief as change from baseline to 15 days in patients with chronic low back pain (LBP).

Dimostrare la superiorità di Tricortin 1000 verso placebo nel migliorare il dolore dopo 15 giorni dalla visita basale, in pazienti affetti da LBP (Low Back Pain) cronico (lombalgia, lombocruralgia e lombosciatalgia).

E.2.2

Secondary objectives of the trial

- To compare Tricortin 1000 and diclofenac sodium medicated plaster (Itami®) in improvement in pain relief as change from baseline to 15 days in patients with LBP.
- To compare Tricortin 1000 with placebo and diclofenac sodium medicated plaster in functional disability improvement, clinical improvement, patient global assessment (PGA), clinical global impression (CGI), consumption of rescue medication, patient safety as change from baseline to 15 days.

- Confrontare Tricortin 1000 ed il cerotto medicato a base di diclofenac sodico (Itami®) in termini di miglioramento del dolore dopo 15 giorni dalla visita basale, in pazienti affetti da LBP.
- Confrontare Tricortin 1000 con placebo ed il cerotto medicato a base di diclofenac sodico in termini di miglioramento della disabilità funzionale, miglioramento clinico, valutazione globale da parte del paziente (PGA), impressione clinica globale (CGI), consumo di rescue medication, sicurezza del paziente dopo 15 giorni dalla visita basale.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Clinical diagnosis of mechanical (mild, moderate degenerative process of disc and facet) LBP, for at least 3 months but no more than 6 months, confirmed (thanks to instrumental analysis obtained within 6 months before the Screening visit) by CT or MRI
2. A moderate to severe Chronic LBP, defined as a score greater or = 4 and less or = 8 rated on the NRS-11
3. Age greater than or equal to 40 and less than or equal to 70 years
4. Patient able to maintain a Diary during the study
5. Patient with a Body Mass Index (BMI) < 30 kg/m2
6. Discontinuation of any analgesic/NSAID therapy, opioids, corticosteroids, skeletal muscle relaxants and any other medication or non-pharmacological therapy (if it would interfere with the study assessments), with no intent to resume during study
7. Patients who did not receive antidepressant medications and/or benzodiazepines for at least 60 days
8. Patient able to read and understand the language and content of the study material, understand the requirements for follow-up visits, is willing to provide information at the scheduled evaluations and is willing and able to comply with the study requirements
9. Patient has undergone the informed consent process and has signed an approved consent form
10. If female, patient must have a negative urine pregnancy test and use a highly effective form of contraception for at least one month prior to screening and throughout the study; or females must be surgically sterile, or postmenopausal as documented in medical history for at least one year. Highly effective birth control methods include: combined hormonal contraception (containing estrogen and progestogen) associated with inhibition of ovulation (oral, intravaginal, transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable); intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomised partner; sexual abstinence
11. Patients who did not use Tricortin 1000 in the past to treat LBP or other pathological conditions.

1. Diagnosi, da almeno 3 mesi, ma da non più di 6, di LBP con eziopatogenesi di tipo meccanico (con processo degenerativo del disco e delle faccette articolari di grado lieve o moderato). Tale diagnosi deve essere confermata da un esame strumentale (TAC o risonanza) effettuato nei 6 mesi precedenti la Visita di Screening;
2. Dolore lombare da moderato a severo, definito come un punteggio maggiore o = 4 e minore o = 8 sulla scala NRS-11;
3. Età compresa tra 40 e 70 anni;
4. Pazienti in grado di mantenere un diario durante lo studio;
5. Pazienti con indice di massa corporea (BMI) < 30 kg/m2;
6. Pazienti che acconsentano ad interrompere il trattamento con qualsiasi farmaco analgesico e antiinfiammatorio non steroideo (FANS), con oppioidi, corticosteroidi, miorilassanti e con qualsiasi altra terapia, farmacologica e non, che possa interferire con le valutazioni di studio, e che siano disponibili a non reintrodurre tali terapie per tutta la durata dello studio;
7. Pazienti che non abbiano assunto antidepressivi e/o benzodiazepine da almeno 60 giorni;
8. Pazienti in grado di leggere e comprendere il linguaggio e il contenuto del materiale di studio, di comprendere le richieste per le visite di follow-up; pazienti disponibili a fornire le informazioni richieste in occasione delle valutazioni previste e in grado di soddisfare i requisiti dello studio;
9. Pazienti che abbiano partecipato al processo di consenso informato e che abbiano firmato un modulo di consenso approvato;
10. Le donne devono risultare negative al test di gravidanza sulle urine e devono utilizzare un metodo di contraccezione altamente efficace da almeno un mese prima della visita di screening e per tutta la durata dello studio; oppure devono essere sterilizzate chirurgicamente o in post menopausa documentata da almeno un anno. I metodi di contraccezione altamente efficaci comprendono: contraccettivi ormonali combinati (estroprogestinici), associati con l’inibizione dell’ovulazione (orali, intravaginali, transdermici); contraccettivi ormonali con solo progestinico, associati con l’inibizione dell’ovulazione (orali, iniettabili o impiantabili); dispositivi intrauterini; sistemi intrauterini a rilascio ormonale; occlusione bilaterale delle tube; partner vasectomizzato; astinenza sessuale;
11. Pazienti che non abbiano usato Tricortin 1000 nel passato per il trattamento del LBP o per altre patologie.

E.4

Principal exclusion criteria

1. Patients suffering of chronic non-specific LBP
2. Females who are pregnant or breast-feeding
3. Patients who are not able to give informed consent
4. Patients who cannot commit to the entire duration of the study
5. Patients with back pain referred from a mechanical cause (except for mild, moderate degenerative process of disc and facet) non spinal source or back pain associated with another specific spinal cause
6. Patients who have a primary bone disease, cancer, infection
7. Other conditions which may confound the interpretation of the study, such as carpal, rheumatoid arthritis, severe venous diseases, peripheral arterial diseases, transient ischemic attack, stroke, current symptoms of coronary artery disease
8. History of narcotic abuse at any time in the past and/or drug or alcohol abuse in the past year
9. Patients who have had a previous treatment with physical therapy for LBP in the last 4 weeks before the screening visit or are going through a course of physical therapy or chiropractic treatment at the time of planned enrolment
10. Participation in another research study
11. History of epilepsy
12. Patients who have an unstable psychiatric condition

1. Pazienti che soffrono di LBP cronico aspecifico;
2. Donne in gravidanza o in allattamento;
3. Pazienti che non sono in grado di dare il consenso informato;
4. Pazienti che non possono impegnarsi per l'intera durata dello studio;
5. Pazienti con dolore lombare dovuto ad una causa meccanica (ad eccezione del processo degenerativo del disco e delle faccette articolari di grado lieve o moderato) di origine non spinale o dolore alla schiena associato ad un'altra causa spinale specifica;
6. Pazienti che hanno una malattia ossea primaria, cancro, infezioni;
7. Altre condizioni che possano interferire con lo studio, come la sindrome del tunnel carpale, l’artrite reumatoide, gravi malattie venose, l’arteriopatia periferica, un attacco ischemico transitorio, l’ictus, la presenza di sintomi di malattia coronarica;
8. Storia di abuso di narcotici in qualsiasi momento del passato e/o abuso di droghe o alcol nell’ultimo anno;
9. Pazienti che abbiano iniziato un programma di terapia fisica per il trattamento del dolore lombare nelle ultime 4 settimane precedenti lo screening, o che abbiano in programma di iniziare un trattamento di terapia fisica o chiropratica al momento dell’inclusione nello studio;
10. Partecipazione ad un altro studio clinico;
11. Storia di epilessia;
12. Pazienti con una condizione psichiatrica instabile.

E.5 End points

E.5.1

Primary end point(s)

Mean change from baseline to Day 15 in NRS-11.

Cambiamento medio dell’NRS-11 al giorno 15 rispetto alla visita basale

E.5.1.1

Timepoint(s) of evaluation of this end point

V2-Day 0 (baseline), V3-Day 7, V4-Day 15

V2-Giorno 0 (basale), V3-Giorno 7, V4-Giorno 15

E.5.2

Secondary end point(s)

LBP related disability improvement will be measured through the Oswestry Low Back Pain Disability Index (ODI), version 2.1a; Clinical improvement evaluated through the following parameters:
- Range of Motion testing
- Joint reflex changes (ROT)
- Lasegue's test (passive straight leg raise)
- Femoral stretch test (Wasserman test)
- Dandy's sign
- Valleix's points pressure; PGA and CGI of the status of LBP ; Daily rescue medication (paracetamol) required for pain relief ; Safety of daily intramuscular Tricortin 1000 injections and of twice daily diclofenac sodium medicated plaster applications evaluated by physical examination, vital signs and by tracking the number of patient withdrawals and their adverse events at each visit.

Miglioramento della disabilità correlata a LBP misurata tramite l'indice di disabilità di Oswestry (ODI), versione 2.1a; Miglioramento clinico valutato tramite i seguenti parametri: - test di flessibilità articolare - valutazione dei riflessi osteotendinei (ROT) - test di Lasegue (manovra di stiramento del nervo sciatico) - test di allungamento femorale (Wasserman test) - segno di Dandy - punti di pressione di Valleix; Impatto del LBP sulla valutazione globale da parte del paziente (PGA) e sull'impressione clinica globale (CGI); Consumo giornaliero della rescue medication (paracetamolo) per migliorare il dolore; Sicurezza delle iniezioni intramuscolari giornaliere di Tricortin 1000 e delle applicazioni bi-giornaliere dei cerotti medicati di diclofenac sodico valutata tramite l'esame fisico, i segni vitali e il numero dei pazienti usciti dallo studio e i loro eventi avversi occorsi a ciascuna visita.

E.5.2.1

Timepoint(s) of evaluation of this end point

At V2-Day 0 (baseline), V3-Day 7 and V4-Day 15; At V2-Day 0 (baseline), V3-Day 7 and V4-Day 15; At V2-Day 0 (baseline), V3-Day 7 and V4-Day 15; At V2-Day 0 (baseline), V3-Day 7 and V4-Day 15; At V2-Day 0 (baseline), V3-Day 7 and V4-Day 15

Alla V2-Giorno 0 (basale), V3-Giorno 7 e V4-Giorno 15; Alla V2-Giorno 0 (basale), V3-Giorno 7 e V4-Giorno 15; Alla V2-Giorno 0 (basale), V3-Giorno 7 e V4-Giorno 15; Alla V2-Giorno 0 (basale), V3-Giorno 7 e V4-Giorno 15; Alla V2-Giorno 0 (basale), V3-Giorno 7 e V4-Giorno 15

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

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)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

Doppio dummy

Double dummy

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

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

Information not present in EudraCT

E.8.7

Trial has a data monitoring committee

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 years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

200

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

100

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

300

F.4.2

For a multinational trial

F.4.2.1

In the EEA

300

F.4.2.2

In the whole clinical trial

300

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

Not planned

Non previsti

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

2018-12-12

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-10-15

P. End of Trial
P.	End of Trial Status	Ongoing

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Clinical trials