Clinical Trials Register

Summary
EudraCT Number:	2022-000693-26
Sponsor's Protocol Code Number:	ATOHS
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:	2022-02-28
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

2022-000693-26

A.3

Full title of the trial

Crossover, Double-blind, Phase 2 Study of a Fixed Dose Combination of Atomoxetine and Acetazolamide Versus Placebo in Obesity Hypoventilation Syndrome

Crossover, doppio cieco, studio di fase 2 di una combinazione a dose fissa di atomoxetina e acetazolamide contro placebo nella sindrome da ipoventilazione da obesità

A.3.1

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

Study of a Fixed Dose Combination of Atomoxetine and Acetazolamide Versus Placebo in Obesity Hypoventilation Syndrome

Studio della combinazione a dose fissa di atomoxetina e acetazolamide contro placebo nella sindrome da ipoventilazione da obesità

A.3.2

Name or abbreviated title of the trial where available

ATOHS

A.4.1

Sponsor's protocol code number

ATOHS

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	ISTITUTO AUXOLOGICO ITALIANO
B.1.3.4	Country	Italy
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	Apnimed INC
B.4.2	Country	United Kingdom
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	ISTITUTO AUXOLOGICO ITALIANO
B.5.2	Functional name of contact point	Dr.ssa Elisa Perger - Centro di Med
B.5.3	Address:
B.5.3.1	Street Address	Via Magnasco, 2
B.5.3.2	Town/ city	Milano
B.5.3.3	Post code	20149
B.5.3.4	Country	Italy
B.5.4	Telephone number	2619112705
B.5.6	E-mail	e.perger@auxologico.it

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	Strattera
D.2.1.1.2	Name of the Marketing Authorisation holder	Eli Lilly Italia 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	Atomoxetina
D.3.2	Product code	[Atomoxetina]
D.3.4	Pharmaceutical form	Capsule, hard
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Atomoxetina
D.3.9.2	Current sponsor code	Atomoxetina
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	25
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	DIAMOX
D.2.1.1.2	Name of the Marketing Authorisation holder	Teofarma S.r.l.
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	Acetazolamide
D.3.2	Product code	[Acetazolamide]
D.3.4	Pharmaceutical form	Capsule, hard
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Acetazolamide
D.3.9.2	Current sponsor code	Acetazolamide
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	250
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.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	Capsule, hard
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Capsule, hard
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Patients with obesity hypoventilation syndrome (OHS)

Pazienti con sindrome da ipoventilazione dell'obesità (OHS)

E.1.1.1

Medical condition in easily understood language

Patients with obesity hypoventilation syndrome (OHS)

Pazienti con sindrome da ipoventilazione dell'obesità (OHS)

E.1.1.2

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

MedDRA Classification

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	10035004
E.1.2	Term	Pickwickian syndrome
E.1.2	System Organ Class	10038738 - Respiratory, thoracic and mediastinal disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To assess the efficacy of atomoxetine/acetazolamide (Ato/Actz) at fixed dose vs placebo in patients with obesity hypoventilation syndrome (OHS)

Valutare l'efficacia di atomoxetina/acetazolamide (Ato/Actz) a dose fissa rispetto al placebo nei pazienti con sindrome da ipoventilazione dell'obesità (OHS)

E.2.2

Secondary objectives of the trial

• Higher proportion of participants without nocturnal hypoventilation on Ato/Actz vs placebo
• Reduction in AHI on Ato/Actz vs placebo

• Proporzione di partecipanti per la quale è risolta l’ipoventilazione notturna dopo utilizzo di Ato/Actz vs placebo
• Percentuale di modifica dell’indice di Apnee/Ipopnee (AHI) tra i gruppi rispetto al basale

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Participant must be able to understand the nature of the study and must have the opportunity to have any questions answered. Participant voluntarily agrees to participate in this study and signs an Ethic Committee -approved informed consent prior to performing any of the Screening Visit procedures.
2. Male or female participants between 18 to 75 years of age
3. BMI > 35 kg/m2, inclusive, at the pre-PSG visit
4. Presence of nocturnal hypoventilation defined as mean PtcCO2 >55 mmHg or >50 mmHg if PtcCO2 increases by more than 10 mmHg for more than 10 minutes of sleep compared to awake supine value
5. Previous surgical treatment for OSA is allowed if = 1 year prior to enrollment.
6. Participants known for OHS and having treatment are eligible for screening/baseline PSG if they report CPAP or BPAP or mandibular advancement device or positional therapy intolerance or poor compliance (compliance is defined as use of CPAP or other treatments for 4 hours per night for 70% of nights; per participant self-report). Participants who had been using CPAP at least 4 hours nightly for at least 70% of the nights are eligible for further screening and baseline PSG for this study only if CPAP or other treatments will not have been used for 2 weeks prior to the screening/baseline PSG for this study.

1. Il partecipante deve essere in grado di comprendere la natura dello studio, deve avere l’opportunità di avere risposte alle domande che pone e deve essere in grado di firmare il consenso informato
2. Maschi o femmine con età compresa tra 18 e 75 anni
3. BMI > 35 kg/m2 compreso, alla visita basale
4. Presenza di ipoventilazione notturna, definita come una PtcCO2 media >55 mmHg o >50 mmHg se l’aumento di PtcCO2 è maggioer di 10 mmHg per più di 10 minuti durante il sonno rispetto al valore di PtcCO2 da sveglio supino.
5. Precedenti interventi chirurgici per l’OSA sono permessi solo se precedono di almeno 1 anno la data di arruolamento
6. Pazienti noti per OHS o OSA in trattamento sono arruolabili per la PSG basale se riportano una ridotta aderenza al trattamento con CPAP, BPAP, terapia posizionale o device di avanzamento mandibolare (l’aderenza è definita come utilizzo di trattamento per 4 ore\notte per almeno 70% delle notti come riportato dal paziente). Pazienti in trattamento sono reclutabili alla notte PSG basale se non stanno utilizzando la CPA da almeno 2 settimane prima della PSG stessa.

E.4

Principal exclusion criteria

1. History of narcolepsy.
2. Clinically significant craniofacial malformation.
3. Clinically significant respiratory (COPD, ILD) or cardiac (Heart Failure, Atrial fibrillation, established severe peripheral arterial disease) disease or hypertension requiring more than 3 medications for control
4. History of renal failure or history of hepatic insufficiency or history of hepatic cirrhosis.
5. History of schizophrenia, schizoaffective disorder or bipolar disorder according to Diagnostic and Statistical Manual of Mental Disorders-V (DSM V) or International Classification of Disease tenth edition criteria.
6. History of attempted suicide or suicidal ideation within 1 year prior to screening, or current suicidal ideation.
7. Positive screen for drugs of abuse or substance use disorder as defined in DSM-V within 12 months prior to Screening Visit.
8. A significant illness or infection requiring medical treatment in the past 30 days.
9. Clinically significant cognitive dysfunction or serious neurological disorder, including serious epilepsy/convulsions.
10. Untreated narrow angle glaucoma.
11. Women who are pregnant or nursing.
12. History of oxygen therapy.
13. Treatment with strong cytochrome P450 3A4 (CYP3A4) inhibitors, or monoamine oxidase inhibitors (MAOI) or linezolid within 14 days of the start of treatment.
14. History of pheochromocytoma.
15. History of diabetes with unstable glucose control in the past 15 days.
16. Chronic use of more than 500 mg/day of Aspirin, due to the potential for an interaction of acetazolamide and very high doses of Aspirin (acetylsalicylic acid, a salicylate drug). 19
17. Allergies to sulfonamides – e.g. hydrochlorothiazide, furosemide, sulfasalazine, celecoxib, sumatriptan, and zonisamide.
18. History of Adrenocortical insufficiency.
19. Known history of low sodium or potassium or evidence of low sodium (<130mEq\L) or potassium (<3meq\L) at blood tests in the last year (if available).
20. History of hyperchloremic acidosis.
21. Any condition that in the investigator’s opinion would present an unreasonable risk to the participant, or which would interfere with their participation in the study or confound study interpretation.
22. Participant considered by the investigator, for any reason, an unsuitable candidate to receive Ato/Acz treatment or unable or unlikely to understand or comply with the dosing schedule or study evaluations.
23. History of using oral or nasal devices (such as mandibular advancement devices) for the treatment of OSA may enroll as long as the devices are not used during participation in the study for at least 2 weeks prior to study begin.
24. History of using devices to affect participant sleeping position for the treatment of OSA, e.g. to discourage supine sleeping position, may enroll as long as the devices are not used during participation in the study.
25. Use of another investigational agent within 30 days or 5 half-lives, whichever is longer, prior to dosing.
26. Patient currently receiving: MAOIs, Serotonin and Norepinephrine Reuptake Inhibitors, Norepinephrine Reuptake Inhibitors, Lithium, Tricyclic antidepressants, strong CYP2D6 inhibitors, other strong inhibitors cytochrome P450, thiazides diuretics, benzodiazepines, opioids, drugs with clinically significant cardiac QT-interval prolonging effects, drugs known to lower seizure threshold, amphetamines, antiepileptics, modafinil or armodafinil, beta2 agonists (if used more than 3 times/week), antipsychotics, pseudoephedrine, phenylephrine, oxymetazoline, drugs for Parkinson’s, Alzheimer’s, Huntington’s, Amyotrophic Lateral Sclerosis, or drugs for other neurodegenerative diseases, more than 500 mg/day of Aspirin or salicylates, sodium Phosphate. (See paragraph 6.7 for details.) If these therapies will be interrupted 2 weeks before the study treatment start, the patient could be included in the study

1. Anamnesi positiva per narcolessia
2. Malformazioni cranio-facciali clinicamente rilevanti
3. Patologie respiratorie significative (BPCO che necessiti di terapia, malattia interstiziale polmonare) o patologie cardiache clinicamente rilevanti o ipertensione che necessiti di più di 3 farmaci per il suo controllo
4. Anamnesi di patologie renali, insufficienza epatica o cirrosi epatica.
5. Anamnesi positiva per schizofrenia, disturbi schizo-affettivo o disturbo bipolare come definite dal Manuale Diagnostico dei Disordini Mentali-V (DSM V) o dalla 10° edizione dei Criteri di Classificazione Internazionale delle Malattie
6. Tentato suicidio o ideazione suicidaria nell’anno precedente alla visita di screening o presenza di ideazione suicidaria al momento della visita
7. Disturbo da abuso di droghe o sostanze, come definite nel DSM-V nei 12 mesi precedenti la visita di screening
8. Patologia o infezione significativa che abbia richiesto trattamento medico negli ultimi 30 giorni
9. Disfunzione cognitiva clinicamente rilevante o patologia neurologica grave, inclusa epilessia
10. Glaucoma ad angolo chiuso non in trattamento
11. Donne in gravidanza o durante allattamento
12. Utilizzo di ossigeno-terapia
13. Trattamento con forti inibitori del citocromo P450 3A4 (CYP3A4), o inibitori delle monoamino ossidasi (MAOI) o linezolid entro i 14 giorni precedenti all’inizio del trattamento in studio o concomitante con il trattamento
14. Anamnesi positiva per feocromocitoma
15. Partecipanti che utilizzino dispositivi per la dissuasione della posizione supina per il trattamento delle OSA possono essere arruolati solo se il dispositivo non verrà utilizzato durante la partecipazione allo studio
16. Utilizzo cronico di aspirina (acido acetil salicilico) con un dosaggio > 500 mg/giorno a causa della potenziale interazione dell’acetazolamide con elevati dosaggi di aspirina.
17. Allergia alle sulfonamidi – es idroclorotiazide, furosemide, sulfasalazina, colecoxib, sumatripan, zonisamide.
18. Anamnesi positiva per insufficienza adreanocorticale
19. Anamnesi positiva per basso sodio o potassio plasmatico o, se disponibili, evidenza di basso sodio (<130mEq\L) o potassio ((<3mEq\L) ad esami ematici dell’ultimo anno.
20. Anamnesi positiva per acidosi ipercloremica
21. Se l’investigatore ritiene che ci possano essere rischi, per qualsiasi causa, che possano interferire con la partecipazione allo studio o alterare l’interpretazione dello studio
22. Se l’investigatore ritiene, per qualsiasi ragione, che il partecipante non sia eleggibile per l’assunzione di atomoxetina\acetazolamide o che possa essere incapace o non aderente con l’assunzione del farmaco come previsto o per le valutazioni in studio
23. Anamnesi positiva per utilizzo di apparecchi nasali o orali per il trattamento delle apnee del sonno possono essere arruolati se l’apparecchio non viene utilizzato per 2 settimane prima dell’inizio dello studio
24. Anamnesi di utilizzo di dissuasori della posizione supina possono essere utilizzati se non usati durante lo studio.
25. Utilizzo di un’altra sostanza in sperimentazione entro 30 giorni o 5 emivite prima dell’assunzione del farmaco in studio
26. Utilizzo dei farmaci elencati nella lista dei farmaci non consentiti in concomitanza con il farmaco in studio

E.5 End points

E.5.1

Primary end point(s)

The primary efficacy endpoint is the mean nocturnal PtcCO2 level from screening/baseline to final day with study treatment.

L'endpoint primario di efficacia è il livello medio notturno di PtcCO2 dallo screening/baseline all'ultimo giorno con il trattamento dello studio

E.5.1.1

Timepoint(s) of evaluation of this end point

9 weeks

9 Settimane

E.5.2

Secondary end point(s)

Gli endpoint secondari saranno la percentuale di partecipanti senza ipoventilazione notturna con Ato/Actz rispetto al placebo e la variazione dell'AHI con Ato/Actz rispetto al placebo. I valori P nominali saranno calcolati per i seguenti endpoint di efficacia per il trattamento rispetto al placebo

Secondary endpoints will be proportion of participants without nocturnal hypoventilation on Ato/Actz vs placebo and the change in AHI on Ato/Actz vs placebo. Nominal P-values will be calculated for the following efficacy endpoints for treatment vs placebo

E.5.2.1

Timepoint(s) of evaluation of this end point

9 weeks

9 settimane

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

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

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

Yes

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

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.8.4.1

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:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

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.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

F.5

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

No subsequent open-label extension is planned following the study. Study treatment will not be available after the end of study participation.

Nessuna fase di estensione in aperto è prevista dopo la conclusione dello studio. Il trattamento dello studio non sarà disponibile al termine della partecipazione al protocollo.

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

2022-05-02

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-03-15

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

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