Clinical Trials Register

Summary
EudraCT Number:	2019-000753-31
Sponsor's Protocol Code Number:	RC19_0055
National Competent Authority:	France - ANSM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2019-05-14
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

France - ANSM

A.2

EudraCT number

2019-000753-31

A.3

Full title of the trial

Evaluation of REMIFENTANIL as an alternative to curare for rapid sequence anesthetic induction in patients at risk of gastric fluid inhalation

Évaluation du REMIFENTANIL en remplacement du curare pour l'induction anesthésique en séquence rapide chez le patient à risque d’inhalation de liquide gastrique

A.3.1

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

Evaluation of REMIFENTANIL as an alternative to curare for rapid sequence anesthetic induction in patients at risk of gastric fluid inhalation

Evaluation du REMIFENTANIL en remplacement du curare pour l'induction anesthésique en séquence rapide chez le patient à risque d’inhalation de liquide gastrique

A.3.2

Name or abbreviated title of the trial where available

REMICrush

A.4.1

Sponsor's protocol code number

RC19_0055

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	CHU Nantes
B.1.3.4	Country	France
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	Ministère de la Santé - DGOS
B.4.2	Country	France
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	CHU NANTES
B.5.2	Functional name of contact point	Direction de la Recherche
B.5.3	Address:
B.5.3.1	Street Address	5, allée de l'Ile Gloriette
B.5.3.2	Town/ city	NANTES
B.5.3.3	Post code	44093
B.5.3.4	Country	France
B.5.4	Telephone number	3325348283533
B.5.5	Fax number	3325348283633
B.5.6	E-mail	bp-prom-reg@chu-nantes.fr

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	REMIFENTANIL
D.2.1.1.2	Name of the Marketing Authorisation holder	MYLAN SAS
D.2.1.2	Country which granted the Marketing Authorisation	France
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	Intravenous use
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.2.5	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	Suxamethonium 50 mg/ml solution injectable
D.3.2	Product code	PRD7135239
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	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	SUXAMETHONIUM CHLORIDE
D.3.9.1	CAS number	71-27-2
D.3.9.4	EV Substance Code	SUB10786MIG
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	50
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 3
D.1.2 and D.1.3	IMP Role	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.2.5	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	Rocuronium 10 mg/ml solution injectable
D.3.2	Product code	PRD7135240
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	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	119302-91-9
D.3.9.3	Other descriptive name	ROCURONIUM BROMIDE
D.3.9.4	EV Substance Code	SUB10353MIG
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.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

anesthetic induction

induction anesthésique

E.1.1.1

Medical condition in easily understood language

anesthetic induction

induction anesthésique

E.1.1.2

Therapeutic area

Not possible to specify

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10002326
E.1.2	Term	Anesthetic induction
E.1.2	System Organ Class	100000004865

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The main objective of the study is to demonstrate the non-inferiority of a rapid sequence anesthetic induction without curare with remifentanil on the prevention of major complications related to tracheal intubation compared to a rapid sequence induction with curare of short duration of action.

L'objectif principal de l'étude est de démontrer la non-infériorité d'une induction anesthésique en séquence rapide sans curare avec rémifentanil sur la prévention des complications majeures liées à l’intubation trachéale en comparaison à une induction en séquence rapide avec curare de court délai d'action.

E.2.2

Secondary objectives of the trial

The secondary objectives are
1) Compare the effectiveness of rapid sequence intubation with or without rapid action curares
2) Compare the tolerance of induction of rapid sequence induction with or without rapid action curares
3) Compare the ability to prevent post-operative respiratory complications

Les objectifs secondaires sont
1) Comparer l’efficacité de l'intubation en séquence rapide avec ou sans curares d'action rapide
2) Comparer la tolérance de l'induction en séquence rapide avec ou sans curares d'action rapide
3) Comparer la capacité de prévention des complications respiratoires post-opératoire

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Female or male.
- Aged 18 to 80 years old
- Intervention requiring general anesthesia with orotracheal intubation
- Anesthetic management with indication of induction in rapid sequence
- Risk of gastric fluid inhalation defined by at least one of the following criteria: fasting period < 6:00 am, digestive obstruction, functional ileus, vomiting < 12:00 pm orthopedic trauma < 12:00 pm, history of severe GERD and/or hiatal hernia and/or gastroparesis and/or dysautonomy and/or gastroesophageal surgery
- Existence of informed and signed consent from the patient, or in the absence of an emergency procedure

Femme ou homme.
- Âgé de 18 à 80 ans
- Intervention nécessitant une anesthésie générale avec intubation orotrachéale
- Prise en charge anesthésique avec indication d'induction en séquence rapide
- Risque d’inhalation de liquide gastrique définit par ou moins l’un des critères suivants : période de jeun < 6h00, occlusion digestive, iléus fonctionnel, vomissements < 12h00 traumatisme orthopédique < 12h00, antécédent de RGO sévère et/ou de hernie hiatale et/ou de gastroparésie et/ou de dysautonomie et/ou chirurgie gastro-œsophagienne
- Existence d'un consentement éclairé et signé du patient, ou à défaut procédure d'urgence

E.4

Principal exclusion criteria

- impossible Intubation planned
- Known or suspected history of allergy to curares and/or remifentanil
- History of neuromuscular disease contraindicating the use of curares
- History of residual curarization
- History of malignant hyperthermia
- Preoperative respiratory distress (SpO2 < 95% in ambient air)
- Preoperative shock (under vasopressor amines)
- Patient in cardiorespiratory arrest
- A woman of childbearing potential and of childbearing potential who has an ongoing pregnancy and/or clinical signs suggestive of an ongoing pregnancy and/or who does not have a contraceptive or contragestive method and has had unprotected sexual relations within 15 days after the last menstrual period.
- Patients under guardianship or curatorship
- Intended use of ETOMIDATE for rapid sequence induction

- Intubation impossible prévue
- Antécédents connus ou suspectés d'allergie aux curares et/ou au rémifentanil
- Antécédent de maladie neuromusculaire contre-indiquant l'utilisation de curares
- Antécédent de curarisation résiduelle
- Antécédent d'hyperthermie maligne
- Détresse respiratoire préopératoire (SpO2 < 95% en air ambiant)
- Etat de choc préopératoire (sous amines vasopressives)
- Patient en arrêt cardiorespiratoire
- Femme en âge de procréer et présentant une grossesse évolutive et/ou présentant des signes cliniques évocateurs d’une grossesse évolutive et/ou ne disposant pas d’un moyen de contraception ou de contragestion et ayant eu des rapports sexuels non protégés dans les 15 jours suivant les dernières menstruations.
- Patients sous tutelle ou curatelle
- Utilisation prévue d’ETOMIDATE pour l’induction en séquence rapide

E.5 End points

E.5.1

Primary end point(s)

The main criteria is the rate of tracheal intubation without major complications defined by the combination of the following criteria:
1) Tracheal intubation after ≤ 2 laryngoscopies
2) Absence of gastric fluid inhalation through the vocal cords within 10 minutes of anesthetic induction
3) Absence of desaturation defined by SpO2 < 95% within 10 minutes of anesthetic induction.
4) Absence of severe hemodynamic instability defined as hypotension (WFP ≤ 50 mmHg) or hypertension (WFP ≥ 110 mmHg) within 10 minutes of anesthetic induction
5) Absence of a sustained ventricular rhythm disorder (i.e., requiring pharmacological or electrical intervention to reduce or last more than 30 seconds), ventricular fibrillation or cardiac arrest within 10 minutes of anesthetic induction
6) Absence of a Grade III or IV anaphylactic reaction of the 2013 HAS classification within 10 minutes of the anesthetic induction

Le critère principal est le taux d’intubation trachéale sans complication majeure définie par l’association des critères suivants :
1) Intubation trachéale après ≤ 2 laryngoscopies
2) Absence de survenue d’une inhalation de liquide gastrique à travers les cordes vocales dans les 10 minutes ayant suivi l’induction anesthésique
3) Absence de désaturation définie par une SpO2 < 95% dans les 10 minutes ayant suivi l’induction anesthésique
4) Absence d’instabilité hémodynamique sévère définit par une hypotension (PAM ≤ 50 mmHg) ou une hypertension (PAM ≥ 110 mmHg) dans les 10 minutes ayant suivi l’induction anesthésique
5) Absence de survenue d’un trouble du rythme ventriculaire soutenue (c.à.d. nécessitant une intervention pharmacologique ou électrique pour être réduite ou durant plus de trente secondes), d’une fibrillation ventriculaire ou d’un arrêt cardiaque dans les 10 minutes ayant suivi l’induction anesthésique
6) Absence de survenue d’une réaction anaphylactique de grade III ou IV de la classification de la HAS 2013 dans les 10 minutes ayant suivi l’induction anesthésique

E.5.1.1

Timepoint(s) of evaluation of this end point

within 10 minutes of anesthetic induction

dans les 10 minutes ayant suivi l’induction anesthésique

E.5.2

Secondary end point(s)

The secondary evaluation criteria are:

1. Intubation quality score (IDS-3 score)
2. The Cormack-Lehane and POGO score values
3. The frequency of patients for whom a technique to assist tracheal intubation was required
4. The time between the administration of the hypnotic (beginning of anesthetic induction) and the achievement of the 6th capnography curve (effective tracheal intubation)
5. The frequency of patients who have had desaturation between 95% and 80% and < 80% of SpO2 within 10 minutes of anesthetic induction.
6. The frequency of patients with severe hemodynamic disorder defined as a heart rate of less than 45 bpm and/or a heart rate of more than 110 bpm and/or a PAS of less than 80 mmHg and/or a PAS of more than 160 mmHg and/or a MAP of less than 55 mmHg and/or a MAP of more than 100 mmHg within 10 minutes of the anaesthetic induction.
7. The frequency of patients with dental or tracheal lesions (endoscopic confirmation for the latter)
8. The frequency of patients who have had a Grade I or II allergic event of the 2013 HAS classification within 10 minutes of the anesthetic induction.
9. Score POST values in SSPI at 1 hour post-extubation (estimation of laryngeal lesions in immediate post-operative care)

Translated with www.DeepL.com/Translator

Les critères d’évaluation secondaires sont :

1. Score de qualité d'intubation (score IDS-3)
2. Les valeurs de scores de Cormack-Lehane et de POGO
3. La fréquence de patient pour lesquels a été nécessaire une technique d'aide à l'intubation trachéale
4. La durée entre l'administration de l'hypnotique (début de l’induction anesthésique) et l’obtention de la 6ème courbe de capnographie (intubation trachéale efficace)
5. La fréquence de patient ayant présenté une désaturation comprise entre 95% et 80% et < à 80% de SpO2 dans les 10 minutes qui suivent l’induction anesthésique.
6. La fréquence de patient ayant présenté un trouble hémodynamique sévère défini par une fréquence cardiaque inférieure à 45 bpm et/ou une fréquence cardiaque supérieur à 110 bpm et/ou une PAS inférieure à 80 mmHg et/ou une PAS supérieur à 160 mmHg et/ou une PAM inférieure à 55 mmHg et/ou une PAM supérieure à 100 mmHg dans les 10 minutes qui suivent l’induction anesthésique.
7. La fréquence de patient ayant présenté des lésions dentaires ou trachéales (confirmation endoscopique pour ce dernier)
8. La fréquence de patient ayant présenté une manifestation allergique de grade I ou II de la classification HAS 2013 dans les 10 minutes qui suivent l’induction anesthésique.
9. Les valeurs de Score POST en SSPI à 1h post-extubation (estimation des lésions laryngées en post-opératoire immédiat)

E.5.2.1

Timepoint(s) of evaluation of this end point

Timepoints of evaluation of these end points are:

1. After intubation
2. After intubation
3. After intubation
4. After intubation
5. within 10 minutes of the anaesthetic induction
6. within 10 minutes of the anaesthetic induction.
7. After intubation
8. within 10 minutes of the anesthetic induction.
9. in immediate post-operative care

Après l'intubation
2. Après l'intubation
3. Après l'intubation
4. Après l'intubation
5. dans les 10 minutes suivant l'induction de l'anesthésie
6. dans les 10 minutes suivant l'induction de l'anesthésie.
7. Après l'intubation
8. dans les 10 minutes suivant l'induction de l'anesthésie.
9. en soins postopératoires immédiats

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)

Yes

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

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)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Chlorure de Suxaméthonium ou Bromure de Rocuronium

Suxamethonium chloride or rocuronium chloride

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

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

Dernière visite du dernier sujet inclus

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:

850

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

300

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 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 2019-05-14.

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

Yes

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

In the event of an urgent surgical procedure to avoid delaying medical and surgical management, an emergency procedure will allow a patient to be included either by the kin or a relative or by the investigator if no kin is present.

En cas de procédure chirurgicale urgente pour ne pas retarder la prise en charge chirurgicale, une procédure d’urgence permettra d’inclure un patient par la personne de confiance/proche ou par l'investigateur si aucun proche n'est présent.

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

1150

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

Aucun

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

2019-06-25

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-07-04

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2021-04-22

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