Clinical Trials Register

Summary
EudraCT Number:	2022-001139-98
Sponsor's Protocol Code Number:	IC2021-07
National Competent Authority:	France - ANSM
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2022-04-25
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

France - ANSM

A.2

EudraCT number

2022-001139-98

A.3

Full title of the trial

Opioid-Free versus Opioid-Based Anaesthesia for secondary free-flap reconstruction surgery of the breast: A phase III multicentric randomized controlled study

Anesthésie sans morphinique versus Anesthésie conventionnelle pour la chirurgie de reconstruction mammaire par lambeau libre : étude de phase III multicentrique randomisée contrôlée

A.3.1

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

Opioid-Free versus Opioid-Based Anaesthesia for secondary free-flap reconstruction surgery of the breast: A phase III multicentric randomized controlled study

Anesthésie sans morphinique versus Anesthésie conventionnelle pour la chirurgie de reconstruction mammaire par lambeau libre : étude de phase III multicentrique randomisée contrôlée

A.3.2

Name or abbreviated title of the trial where available

OFOBA

A.4.1

Sponsor's protocol code number

IC2021-07

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	Institut Curie
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	DGOS-PHRC-I 2020
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	Institut Curie
B.5.2	Functional name of contact point	DREH Pôle Promotion
B.5.3	Address:
B.5.3.1	Street Address	35 rue Dailly
B.5.3.2	Town/ city	SAINT-CLOUD
B.5.3.3	Post code	92210
B.5.3.4	Country	France
B.5.4	Telephone number	33147 11 16 57
B.5.6	E-mail	drci.promotion@curie.fr

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	DEXMEDETOMIDINE EVER PHARMA 100 microgrammes/mL
D.2.1.1.2	Name of the Marketing Authorisation holder	EVER VALINJECT GMBH
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.3.1	Product name	DEXMEDETOMIDINE
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	Solution for infusion (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	DEXMEDETOMIDINE HYDROCHLORIDE
D.3.9.1	CAS number	145108-58-3
D.3.9.2	Current sponsor code	EVER VALINJECT GMBH
D.3.9.4	EV Substance Code	SUB20317
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	100
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.2.1.1.1	Trade name	LIDOCAÏNE KABI 10 mg/mL
D.2.1.1.2	Name of the Marketing Authorisation holder	FRESENIUS KABI FRANCE
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.3.1	Product name	LIDOCAÏNE
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	Solution for injection (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	LIDOCAINE HYDROCHLORIDE MONOHYDRATE
D.3.9.1	CAS number	6108-05-0
D.3.9.4	EV Substance Code	SUB02922MIG
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: 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.2.1.1.1	Trade name	REMIFENTANIL MYLAN 1 mg
D.2.1.1.2	Name of the Marketing Authorisation holder	MYLAN S.A.S
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.3.1	Product name	REMIFENTANIL
D.3.4	Pharmaceutical form	Powder for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Injection (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	REMIFENTANIL
D.3.9.3	Other descriptive name	REMIFENTANIL HYDROCHLORIDE
D.3.9.4	EV Substance Code	SUB04215MIG
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	1
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

Anaesthesia during secondary free flap reconstruction surgery of the breast.

Anesthésie lors de la chirurgie de reconstruction mammaire secondaire par lambeau libre.

E.1.1.1

Medical condition in easily understood language

Anaesthesia during secondary free flap reconstruction surgery of the breast.

Anesthésie lors de la chirurgie de reconstruction mammaire secondaire par lambeau libre.

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	LLT
E.1.2	Classification code	10002323
E.1.2	Term	Anesthesia general
E.1.2	System Organ Class	10042613 - Surgical and medical procedures

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10006305
E.1.2	Term	Breast reconstruction
E.1.2	System Organ Class	10042613 - Surgical and medical procedures

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Compare morphine consumption during the first 48 hours postoperatively between the OFA group and the CGA control group

Comparer la consommation de morphine pendant les 48 premières heures en post-opératoire entre le groupe OFA et le groupe contrôle CGA.

E.2.2

Secondary objectives of the trial

1. Compare intraoperative hemodynamic stability.
2. Compare sedation scores in the Post-Anaesthesia Care Unit.
3. Compare the incidence of postoperative nausea and vomiting in the PACU, at D0, D1 and D2.
4. Compare the self-evaluation of pain at rest and during mobilization on the Visual Analogical Evaluation scale in the PACU, at D0, D1 and D2.
5. Compare morphine consumption in titration in the PACU.
6. Compare number of boluses demand on PCA in the two groups.
7. Compare the DN4 pain scores at D2, D4, 1 month, 3 months and 6 months post-operatively.
8. Compare the PACU length of stay and the in-hospital postoperative length of stay.
9. Compare the flap failure rate and the re-exploration of the microsurgical anastomosis rate.
10. Compare the patients' pain management satisfaction scores at discharge.
11. Evaluate the incidence of serious adverse events during 30 days after the surgery.
12. Evaluate rescue remifentanil consumption in the OFA group.

1.Comparer la stabilité hémodynamique en per-opératoire.
2.Comparer les scores de sédation en SSPI.
3.Comparer l'incidence des nausées et vomissements postopératoires en SSPI, à J0, J1 et J2.
4.Comparer l’auto-évaluation maximale de la douleur au repos et à la mobilisation sur échelle Evaluation Visuelle Analogique en SSPI, à J0, J1 et J2.
5.Comparer la consommation de morphine en titration en SSPI.
6.Comparer la demande de bolus sur PCA entre les deux groupes.
7.Comparer les scores de douleur neuropathique DN4 à J2, J4, 1 mois, 3 mois et 6 mois post-opératoires.
8.Comparer la durée de séjour en SSPI et la durée d’hospitalisation.
9.Comparer le taux d’échec et de reprise de lambeau.
10.Comparer les scores de satisfaction de prise en charge de la douleur des patientes à la sortie d’hospitalisation.
11.Evaluer l’incidence des évènements indésirables graves durant les 30 jours après la date de chirurgie.
12.Evaluer la consommation de rémifentanil dans le groupe OFA.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1.Women aged 18 or older.
2.Patients with a French health insurance coverage (having a French social security number).
3.Patient eligible for secondary free flap reconstruction surgery of the breastunder general anaesthesia.
4.Patient who has given written consent to participate in accordance with the regulations.
5.Having a negative blood pregnancy test for patients of childbearing age.

1.Femme âgée de 18 ans ou plus.
2.Bénéficiant d'un régime de sécurité sociale.
3.Patiente pouvant bénéficier d’une chirurgie de construction mammaire secondaire par lambeau libre sous anesthésie générale.
4.Patiente ayant donné son consentement écrit de participation conformément à la réglementation.
5.Ayant un test de grossesse sanguin négatif pour les patientes en âge de procréer.

E.4

Principal exclusion criteria

1.Allergy or intolerance to any of the drugs (dexmedetomidine, remifentanil, lidocaine, propofol, dexamethasone, kétamine, ketoprofen, nefopam, paracetamol, morphine, ropivacaine, droperidol, ondansetron).
2.Known history of heart failure, arrhythmias and/or ischemic heart disease and/or severe renal insufficiency.
3.Pulse below 50bpm during anaesthesia consultation and/or under beta-blocker treatment.
4.Treatment with ACEI/ARB.
5.Severe asthma.
6.Symptomatic gastric or duodenal ulcer with or without treatment.
7.Baseline systolic blood pressure < 100 mmHg.
8.Chronic preoperative pain and/or use of WHO ladder step 2 or 3 analgesics preoperatively.
9.Patient already included in another therapeutic trial evaluating an experimental molecule.
10.Persons deprived of liberty or under guardianship.
11.Patients with suspected difficulties in assessing pain on a scale.
12.Inability to undergo trial medical monitoring due to geographic, social or psychological reasons.

1.Allergie ou intolérance à l'un des médicaments (dexmédétomidine, rémifentanil, lidocaine, propofol, dexaméthasone, kétamine, kétoprofène, néfopam, paracétamol, morphine, ropivacaine, dropéridol, ondansétron).
2.Antécédents connus d'insuffisance cardiaque, de troubles du rythme et/ou de cardiopathie ischémique et/ou insuffisance rénale sévère.
3.Pouls inférieur à 50bpm en consultation d’anesthésie et/ou sous traitement par bêta-bloquants.
4.Traitement par IEC/ARAII.
5.Asthme sévère.
6.Ulcère gastrique ou duodénal symptomatique traité ou non.
7.Pression artérielle systolique de base < 100 mmHg.
8.Douleur chronique préopératoire et/ou consommation d’antalgiques palier 2 ou 3 en préopératoire.
9.Patient déjà inclus dans un autre essai thérapeutique évaluant une molécule expérimentale.
10.Personnes privées de liberté ou sous tutelle.
11.Patientes ayant des difficultés pressenties d’évaluation de la douleur sur une échelle.
12.Impossibilité de se soumettre au suivi médical de l'essai pour des raisons géographiques, sociales ou psychiques.

E.5 End points

E.5.1

Primary end point(s)

Morphine consumption during the first 48 hours postoperatively (mg).

Consommation de morphine pendant les premières 48 heures en post-opératoire (mg).

E.5.1.1

Timepoint(s) of evaluation of this end point

During the first 48 hours postoperatively

Pendant les premières 48 heures en post-opératoire

E.5.2

Secondary end point(s)

1. Assessment of vasopressor requirement and total intraoperative filling volume.
2.Assessment of the state of consciousness on arrival in the PACU (S0 Awake, S1 Drowsy, responds to call, S2 Drowsy responds to touch, S3 non awake comatose).
3.Assessment of the incidence of PONV in the PACU, at D0, D1 and D2.
4.Maximum VAS at rest and mobilization in the PACU, at D0, D1 and D2.
5.Dose of morphine given in titration in the PACU (mg).
6.Number of boluses demand on PCA during the first 48 hours postoperatively.
7.DN4 score (Neuropathic Pain 4) on D2, D4, M1, M3 and M6 (during a follow-up visit by a pain specialist).
8.Length of stay in PACU (h) and length of in-hospital postoperative length of stay (D).
9.Assessment of the flap failure rate (flap removal surgery) and flap micro-anastomosis re-exploration rate.
10.Pain management satisfaction scores (score from 0 to 10) at discharge.
11.Collection of serious adverse events between D0 (date of surgery) and D30.
12.Dose of intraoperative rescue remifentanil in the OFA group (mcg).

1.Evaluation du besoin en vasopresseurs et du volume total de remplissage en per-opératoire.
2.Evaluation de l’état de conscience à l’arrivée en SSPI (S0 Eveillée, S1 Somnolente, répond à l’appel, S2 Somnolente répond au toucher, S3 non réveillable comateuse).
3.Nombre d’épisodes de NVPO en SSPI, à J0, J1 et J2.
4.EVA maximale au repos et à la mobilisation en SSPI, à J0, J1 et J2.
5.Dose de morphine donnée en titration en SSPI (mg).
6.Nombre de bolus de morphine demandé sur PCA pendant les premières 48 heures en post-opératoire.
7.Score DN4 (Douleur Neuropathique 4) J2, J4, M1, M3 et M6 (lors d'une visite de contrôle par un MAR, un médecin/IDE spécialiste de la douleur).
8.Durée de séjour en SSPI (h) et durée d’hospitalisation post-opératoire (J).
9.Estimation du taux d’échec de lambeau (chirurgie de dépose de lambeau) et de reprise de lambeau (chirurgie de ré-évaluation de la micro-anastomose).
10.Scores de satisfaction de prise en charge de la douleur (ENS : score de 0 à 10) à la sortie d’hospitalisation.
11.Recueil des évènements indésirables graves entre J0 (date de la chirurgie) et J30.
12.Dose totale de rémifentanil (µg) per-opératoire dans le groupe OFA.

E.5.2.1

Timepoint(s) of evaluation of this end point

1.In intraoperative.
2.On arrival in the PACU (.
3.In the PACU, at D0, D1 and D2.
4.In the PACU, at D0, D1 and D2.
5.In the PACU (mg).
6.During the first 48 hours postoperatively.
7.On D2, D4, M1, M3 and M6.
8.In PACU (h) and discharge.
9.At discharge.
10.At discharge.
11.Between D0 and D30.
12.Intraoperative.

1.En per-opératoire.
2.A l’arrivée en SSPI.
3.En SSPI, à J0, J1 et J2.
4.En SSPI, à J0, J1 et J2.
5.En SSPI.
6.En post-opératoire.
7.J2, J4, M1, M3 et M6.
8.En SSPI et sortie d'hospitalisation.
9.Sortie d'hospitalisation.
10.Sortie d’hospitalisation.
11.Entre J0 et J30.
12.En per-opératoire.

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

E.6.5

Efficacy

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

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

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

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 patient

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:

158

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

158

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

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

158

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)

Follow-up at 1 month, 3 months and 6 months.

Suivi à 1 mois, 3 mois et 6 mois.

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

2022-06-01

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-06-13

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

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