Clinical Trials Register

Summary
EudraCT Number:	2018-001661-17
Sponsor's Protocol Code Number:	H8H-MC-LAIJ
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2021-06-17
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2018-001661-17

A.3

Full title of the trial

Randomized Controlled Trial of Lasmiditan Over Four Migraine Attacks

Studio controllato randomizzato con Lasmiditan in quattro attacchi di emicrania

A.3.1

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

Study of Lasmiditan (LY573144) Over Four Migraine Attacks

Studio con Lasmiditan (LY573144) in quattro attacchi di emicrania

A.3.2

Name or abbreviated title of the trial where available

A.4.1

Sponsor's protocol code number

H8H-MC-LAIJ

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT03670810

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	ELI LILLY & COMPANY, LILLY CORPORATE CENTER
B.1.3.4	Country	United States
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	Eli Lilly and Company
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Eli Lilly and Company
B.5.2	Functional name of contact point	Clinical Trial Registry Office
B.5.3	Address:
B.5.3.1	Street Address	Lilly Corporate Center DC 1526
B.5.3.2	Town/ city	Indianapolis
B.5.3.3	Post code	46285
B.5.3.4	Country	United States
B.5.6	E-mail	EU_Lilly_Clinical_Trials@lilly.com

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	No
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	Lasmiditan
D.3.2	Product code	[LY573144]
D.3.4	Pharmaceutical form	Tablet
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.3.9.2	Current sponsor code	LY573144
D.3.9.4	EV Substance Code	SUB187183
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	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	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	No
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	Lasmiditan
D.3.2	Product code	[LY573144]
D.3.4	Pharmaceutical form	Tablet
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.3.9.2	Current sponsor code	LY573144
D.3.9.4	EV Substance Code	SUB187183
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	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	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	Tablet
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	Tablet
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

Migraine

Emicrania

E.1.1.1

Medical condition in easily understood language

Migraine

Emicrania

E.1.1.2

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

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	10027599
E.1.2	Term	Migraine
E.1.2	System Organ Class	10029205 - Nervous system 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 evaluate the efficacy of lasmiditan 200 mg and 100 mg on migraine headache pain freedom compared to placebo.
To evaluate the consistency of response to lasmiditan 200 mg and 100 mg compared to placebo.

Valutare l’efficacia di lasmiditan 200 mg e 100 mg nel contrastare il dolore dovuto a emicrania rispetto al placebo
Valutare la coerenza delle risposte a lasmiditan 200 mg e 100 mg rispetto al placebo

E.2.2

Secondary objectives of the trial

To evaluate the efficacy of lasmiditan 200 mg and 100 mg on freedom from MBS compared to placebo.
To evaluate the efficacy of lasmiditan 200 mg and 100 mg on pain relief compared to placebo.

Valutare l’efficacia di lasmiditan 200 mg e 100 mg per quanto riguarda l’assenza di MBS rispetto al placebo
Valutare l’efficacia di lasmiditan 200 mg e 100 mg nell’alleviare il dolore rispetto al placebo

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Are of an acceptable age to provide informed consent according to the
local regulations and are at least 18 years of age at time of screening
with migraine with or without aura fulfilling the IHS (International
Headache Society) diagnostic criteria 1.1 and 1.2.1
· History of disabling migraine for at least 1 year.
· Migraine onset before the age of 50 years.
· History of 3 to 8 migraine attacks per month (<15 headache days per
month).
· MIDAS score =11.
· Able and willing to complete an eDiary to record the details of each
migraine attack treated with study drug.
· Women of child-bearing potential must be using or willing to use a
highly effective form of contraception until 30 days after the last dose.
· Agree not to post any personal medical data or information related to
the study on any website or social media site until the entire trial has
completed.
· Are able and willing to give signed informed consent

Avere un’età adeguata per fornire il consenso informato ai sensi dei
regolamenti locali e avere almeno 18 anni al momento dello screening,
soffrire di emicrania con o senza aura e soddisfare i criteri diagnostici
1.1 e 1.2.1 della IHS (Società Internazionale delle Cefalee).
· Anamnesi di emicrania invalidante da almeno 1 anno.
· Insorgenza dell’emicrania prima dei 50 anni d’età.
· Anamnesi di 3-8 attacchi di emicrania al mese (<15 giorni di cefalea al
mese).
· Punteggio MIDAS =11.
· Capacità e volontà di compilare un eDiary per registrare i dettagli di ciascun
attacco di emicrania trattato con il farmaco sperimentale.
· Le donne in età fertile devono utilizzare, o essere disposte a utilizzare,
un metodo contraccettivo ad alta efficacia fino a che siano trascorsi 30 giorni dalla somministrazione dell’ultima dose.
· Consenso a non pubblicare alcun dato medico personale o alcuna informazione correlata allo
studio su siti web o social network fino alla
conclusione dell’intero studio.
· Volontà e capacità di fornire e firmare il proprio consenso informato.

E.4

Principal exclusion criteria

Known hypersensitivity to lasmiditan, or to any excipient of lasmiditan
oral tablets
· History or evidence of hemorrhagic stroke, epilepsy, or any other
condition placing the participant at increased risk of seizures
· History of recurrent dizziness and/or vertigo including benign
paroxysmal positional vertigo, Meniere's disease, vestibular migraine,
and other vestibular disorders
· History of diabetes mellitus with complications (diabetic retinopathy,
nephropathy, or neuropathy)
· History of orthostatic hypotension with syncope
· Significant renal or hepatic impairment in the opinion of the
investigator or if they meet hepatic monitoring criteria
· Participants who, in the investigator's judgment, are actively suicidal
and therefore deemed to be at significant risk for suicide
· History, within past 12 months, of chronic migraine or other forms of
primary or secondary chronic headache disorder (eg, hemicranias
continua, medication overuse headache where headache frequency is =
15 headache days per month)
· Use of more than 3 doses per month of either opioids or barbiturates
· Initiation of or a change in concomitant medication to reduce the
frequency of migraine episodes within 3 months prior to screening
· Pregnant or breast-feeding women
· History of drug or alcohol abuse/dependence within 1 year prior to
screening
· Any medical condition or clinical laboratory test which in the judgment
of the investigator makes the participant unsuitable for the study
· Currently enrolled in any other clinical study involving an
investigational product
· Relatives of, or staff directly reporting to, the Investigator
· Participants who are employees of the sponsor

· Ipersensibilità nota a lasmiditan o a qualsiasi eccipiente delle
compresse orali di lasmiditan.
· Anamnesi o evidenza di ictus emorragico, epilessia o qualsiasi altra
condizione che espone il partecipante a un maggiore rischio di sviluppare crisi convulsive.
· Anamnesi di capogiri e/o vertigini ricorrenti, tra cui
vertigini parossistiche posizionali benigne, malattia di Ménière, emicrania vestibolare
e altri disturbi vestibolari.
· Anamnesi di diabete mellito associato a complicanze (retinopatia diabetica,
nefropatia o neuropatia).
· Anamnesi di ipotensione ortostatica associata a sincope.
· Compromissione renale o epatica significativa a giudizio dello
sperimentatore oppure qualora vengano soddisfatti i criteri di monitoraggio epatico.
· Partecipanti che, a giudizio dello sperimentatore, hanno intenti suicidi in corso
e pertanto sono ritenuti significativamente a rischio di suicidio.
· Anamnesi, nei 12 mesi precedenti, di emicrania cronica o di altre forme di
cefalea cronica primaria o secondaria (ad es. emicrania
continua, cefalea dovuta all’uso eccessivo di farmaci con frequenza della cefalea =
15 giorni di cefalea al mese).
· Utilizzo di più di 3 dosi mensili di oppioidi o barbiturici.
· Avvio o variazione della terapia concomitante per ridurre la
frequenza degli episodi di emicrania nei 3 mesi precedenti lo screening.
· Donne in stato di gravidanza o in allattamento.
· Anamnesi di abuso di sostanze stupefacenti o alcol, o di dipendenza da tali sostanze, nell’anno che precede
lo screening.
· Qualsiasi condizione medica o analisi cliniche di laboratorio che, a giudizio
dello sperimentatore, rendono il paziente non idoneo allo studio.
· Soggetto attualmente arruolato in un altro studio clinico in cui è previsto l’uso di un
prodotto sperimentale.
· Parenti dello sperimentatore o personale che dipende direttamente da quest’ultimo.
· Partecipanti dipendenti dello sponsor.

E.5 End points

E.5.1

Primary end point(s)

1. Percentage of patients in each group that are pain free (defined as
mild, moderate, or severe headache pain becoming none).
2. Percentage of patients in each group that are pain free (defined as
mild, moderate, or severe headache pain becoming none).

1. percentuale di pazienti in ciascun gruppo che non accusano dolore (definito come il passaggio da cefalea di grado lieve, moderato o severo a nessun dolore)
2. percentuale di pazienti in ciascun gruppo che non accusano dolore (definito come il passaggio da cefalea di grado lieve, moderato o severo a nessun dolore)

E.5.1.1

Timepoint(s) of evaluation of this end point

1: at 2 hours postdose during the first attack.
2: at 2 hours postdose in at least 2 out of 3 attacks.

1: a 2 ore post-dose durante il primo attacco
2 a 2 ore post-dose in almeno due su tre attacchi.

E.5.2

Secondary end point(s)

3. Percentage of Participants Free of Most Bothersome Symptom (MBS)
Associated with Migraine.
4. Percentage of Participants with Pain Relief.
5. Percentage of Participants with 24-Hour Sustained Pain Freedom
during the First Attack.
6. Percentage of Participants Requiring Rescue Medication for Migraine.
7. Percentage of Participants that are Free of Symptoms Associated with
Migraine.
8. Percentage of Participants with Migraine Recurrence.
9. Percentage of Participants with Pain Freedom, Pain Relief, Freedom
from MBS, and No Disability During First Attack.
10. Change from Baseline in Total Score as Measured by the MIDAS Scale.
11. Percentage of Participants with no Disability as Measured by the
Disability Item.
12. Percentage of Participants Very Much or Much Better as Measured by
Patient Global Impression of Change (PGI-C).
13. Mean HRQoL score for domains of social functioning, migraine
symptoms, and feelings/concerns, as measured by the 24-hour MQoLQ.
14. Change from Baseline in Utility as Measured by the EuroQol 5-
Dimension 5-Level Scale (EQ-5D-5L).
15. Percentage of Participants with Pain Relief.
16. Percentage of Participants that are Pain Free.
17. Percentage of Participants with Pain Relief.

3. percentuale di partecipanti Esenti da Sintomi Soggettivi (Most Bothersome Symptom (MBS) Associati ad Emicrania.
4. percentuale di partecipanti con Riduzione del Dolore
5. percentuale di partecipanti che dichiarano Assenza di dolore per 24 ore continuative durante il primo attacco
6. percentuale di partecipanti che necessitano di un Farmaco di Soccorso per Emicrania
7. percentuale di partecipanti esenti da sintomatologia associata a Emicrania
8. percentuale di partecipanti con Eventi Ricorrenti di Emicrania
9. percentuale di partecipanti con Assenza di dolore, Riduzione del Dolore, Assenza di Sintomi Soggettivi (MBS), e con Assenza di Invalidità durante il primo attacco
10. Variazione rispetto al Baseline nel Punteggio totale calcolato mediante la Scala di valutazione MIDAS.
11. percentuale di partecipanti con Nessuna Invalidità in riferimento alla Voci di delle Invalidità
12. percentuale di partecipanti classificati come molto o sensibilmente migliorati secondo la “Impressione Globale Paziente dell'analisi del Cambiamento (PGIC)
13. Punteggio HRQoL medio per gli ambiti: Capacità di Svolgere una Funzione Sociale, sintomatologia da emicrania, e sensazioni/preoccupazioni, misurato mediante il questionario Migraine Quality of Life Questionnaire (MQOLQ ) a 24 ore
14. Variazione rispetto al Baseline nella classificazione delle Abilità correlate allo stato di salute (Utility) misurata secondo la scala di valutazione EuroQol 5-Dimension 5-Level Scale (EQ-5D-5L).
15. percentuale di partecipanti con Riduzione del Dolore
16. percentuale di partecipanti con Assenza di dolore
17. percentuale di partecipanti con Riduzione del Dolore

E.5.2.1

Timepoint(s) of evaluation of this end point

3. at 2 Hours Postdose During the First Attack.
4. at 2 Hours Postdose during the First Attack.
5. with 24-Hour Sustained Pain Freedom during the First Attack.
6. within 24 Hours of Treatment during the First Attack.
7. at 2 Hours Postdose During the First Attack.
8. at 24 Hours During the First Attack.
9. 2 Hours Postdose.
10. Baseline, Week 16.
11. at 2 Hours Postdose during the First Attack.
12. at 2 hours Postdose during the first attack.
13. at 24 hours post first dose of study during first attack.
14. Baseline, 24 Hours Postdose.
15. at 2 Hours Postdose in at Least 2 out of 3 Attacks
16, 17. at 2 Hours Postdose in at Least 3 out of 4 Attacks.

3. a 2 ore post-dose durante il primo attacco
5. con Assenza di dolore per 24 ore continuative durante il primo attacco
6. entro 24 ore dal trattamento durante il primo attacco
7. a 2 ore post-dose durante il primo attacco
8. a 24 ore durante il primo attacco
9. 2 Hours Postdose.
10. Baseline, Week 16.
11. at 2 Hours Postdose during the First Attack.
12. at 2 hours Postdose during the first attack.
13. a 24 ore dopo la prima dose dello studio durante il primo attacco
14. Baseline, 24 Hours Postdose.
15. a 2 ore post-dose in almeno 2 su 3 attacchi

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

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

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

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

China

India

Mexico

Russian Federation

United States

Austria

Belgium

Denmark

France

Germany

Hungary

Italy

Netherlands

Spain

Switzerland

United Kingdom

Czechia

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

End of the study is the date of the last visit or last scheduled procedure shown in the Schedule of Activities for the last patient.

La fine dello studio è la data dell'ultima visita o dell'ultima procedura prevista dalla lista delle attività per l'ultimo paziente.

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:

1440

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

160

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

1221

F.4.2.2

In the whole clinical trial

1600

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)

Subject will return to their normal standard of care therapy as determined by their physician

I soggetti riprenderanno ad assumere la normale terapia standard secondo le indicazioni del loro medico curante

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

2019-07-12

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-05-08

P. End of Trial
P.	End of Trial Status	Completed

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IMP with orphan designation in the indication
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