Clinical Trials Register

Summary
EudraCT Number:	2020-001009-22
Sponsor's Protocol Code Number:	19356A
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2022-04-11
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2020-001009-22

A.3

Full title of the trial

Interventional, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of IV eptinezumab in adolescents (12-17 years) for the preventive treatment of chronic migraine

Estudio intervencionista, aleatorizado, doble ciego, de grupos paralelos y controlado con placebo para evaluar la eficacia y la seguridad de eptinezumab IV en adolescentes (12-17 años) para el tratamiento preventivo de la migraña crónica

A.3.1

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

Interventional, randomized, double-blind, parallel-group, placebocontrolled study to evaluate the efficacy and safety of IV eptinezumab in adolescents (12-17 years) for the preventive treatment of chronic migraine

A.3.2

Name or abbreviated title of the trial where available

PROSPECT-2

A.4.1

Sponsor's protocol code number

19356A

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/091/2022

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	H. Lundbeck A/S
B.1.3.4	Country	Denmark
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	H. Lundbeck A/S
B.4.2	Country	Denmark
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	H. Lundbeck A/S
B.5.2	Functional name of contact point	LundbeckClinicalTrials@lundbeck.com
B.5.3	Address:
B.5.3.1	Street Address	Ottiliavej 9
B.5.3.2	Town/ city	Valby
B.5.3.3	Post code	2500
B.5.3.4	Country	Denmark
B.5.4	Telephone number	+34900 834 223
B.5.6	E-mail	RegistroEspanolDeEstudiosClinicos@druginfo.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	Yes
D.2.1.1.1	Trade name	Vyepti
D.2.1.1.2	Name of the Marketing Authorisation holder	H. Lundbeck A/S
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Eptinezumab
D.3.4	Pharmaceutical form	Concentrate for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Infusion (Noncurrent) Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Eptinezumab
D.3.9.2	Current sponsor code	Lu AG09221
D.3.9.4	EV Substance Code	SUB188646
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	100
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	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	Vyepti
D.2.1.1.2	Name of the Marketing Authorisation holder	H. Lundbeck A/S
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Eptinezumab
D.3.4	Pharmaceutical form	Concentrate for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Infusion (Noncurrent) Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Eptinezumab
D.3.9.2	Current sponsor code	Lu AG09221
D.3.9.4	EV Substance Code	SUB188646
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	100
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for infusion
D.8.4	Route of administration of the placebo	Intravenous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Migraine

Migraña

E.1.1.1

Medical condition in easily understood language

Migraine

Migraña

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 find out if eptinezumab is better than placebo (normal saline solution) in lowering the number of days with migraine in young people ages 12 to 17 with chronic migraine.

Averiguar si eptinezumab es mejor que placebo (solución salina normal) para reducir la cantidad de días con migraña en jóvenes de 12 a 17 años con migraña crónica.

E.2.2

Secondary objectives of the trial

To evaluate the population pharmacokinetics and immunogenicity of eptinezumab administered IV to patients 12 to 17 years of age with CM

Evaluar la farmacocinética poblacional y la inmunogenicidad de eptinezumab administrado mediante vía IV a pacientes de 12 a 17 años con MC

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- The participant has a diagnosis of migraine (with or without aura) as defined by International Classification of Headache Disorders 3 (ICHD-3) guidelines with history of chronic migraine, of at least 6 months prior to the screening visit.

- During the 28-day screening period, the participant must adequately complete the headache eDiary on at least 24 of the 28 days following the screening visit.

- During the 28-day screening period, the participant must have ≥15 to ≤26 headache days, of which at least 8 are migraine days as documented in the eDiary.

- Diagnóstico de migraña (con o sin aura) de acuerdo con la Clasificación Internacional de Cefaleas 3 (ICHD-3) con antecedentes de migraña crónica durante al menos 6 meses antes de la visita de selección.
- Durante la fase de selección de 28 días, el paciente debe rellenar adecuadamente el diario electrónico de cefaleas durante al menos 24 de los 28 días tras la visita de selección.
- Durante la fase de selección de 28 días, el paciente debe tener ≥15 y ≤26 días de cefalea, de los cuales, al menos, 8 son días de migraña, documentados en el diario electrónico.

E.4

Principal exclusion criteria

- The participant has previously been enrolled in this study and exposed to eptinezumab.

- The participant has been exposed to any monoclonal antibody treatment (including exposure in a study) <6 months prior to the screening visit.

- The participant has been exposed to another calcitonin gene-related peptide (CGRP) antibody (including exposure in a study investigating a CGRP antibody) <6 months prior to the screening visit.

- The participant has a history or diagnosis of complicated migraine (ICHD-3 version, 2018), chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or unusual migraine subtypes such as hemiplegic migraine (sporadic and familial), migraine with brainstem aura, ophthalmoplegic migraine, or migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration).

- El participante ha sido previamente reclutado en este estudio y expuesto a eptinezumab.
- El participante ha estado expuesto a cualquier tratamiento con anticuerpos monoclonales (incluida la exposición en un estudio) <6 meses antes de la visita de selección.
- El participante ha estado expuesto a otro anticuerpo del péptido relacionado con el gen de la calcitonina (CGRP) (incluida la exposición en un estudio que investiga un anticuerpo CGRP) <6 meses antes de la visita de selección.
- El participante tiene antecedentes o diagnóstico de migraña complicada (ICHD-3 versión, 2018), cefalea tensional crónica, cefalea hípnica, cefalea en brotes, hemicránea continua, cefalea persistente diaria nueva o subtipos de migraña inusuales como la migraña hemipléjica (esporádica y familiar), migraña con aura de tronco encefálico, migraña oftalmopléjica o migraña con acompañamiento neurológico que no es típico del aura de migraña (diplopía, alteración de la conciencia o
duración prolongada).

E.5 End points

E.5.1

Primary end point(s)

1. Change From Baseline in Monthly Migraine Days (MMDs) Averaged Over Weeks 1-12

1. Cambio desde el inicio en días de migraña mensuales (DMM) promediado durante las semanas 1 a 12

E.5.1.1

Timepoint(s) of evaluation of this end point

1. Time Frame: Baseline, Weeks 1-12

1. Marco de tiempo: línea de base, semanas 1-12

E.5.2

Secondary end point(s)

1. Percentage of Participants With 50% Reduction From Baseline in MMDs Averaged Over Weeks 1-12

2. Percentage of Participants With Migraine on the Day After Dosing (Day 1)

3. Change From Baseline in MMDs With Use of Acute Medication Averaged Over Weeks 1-12

4. Percentage of Participants With 75% Reduction From Baseline in MMDs Averaged Over Weeks 1-12

5. Percentage of Participants With 75% Reduction From Baseline in MMDs Averaged Over Weeks 1-4

6. Percentage of Participants With 50% Reduction From Baseline in MMDs Averaged Over Weeks 1-4

7. Change From Baseline in Monthly Headache Days Averaged Over Weeks 1-12

8. Change From Baseline in Rate of Migraines With Severe Pain Intensity Averaged Over Weeks 1-12

9. Change From Baseline in Days With Use of Acute Medication Averaged Over Weeks 1-12

10. Change From Baseline in Pediatric Migraine Disability Assessment Questionnaire (PedMIDAS) Score Averaged Over Weeks 1-12

11. Free Eptinezumab Plasma Concentration

12. Number of Participants With Specific Anti-Eptinezumab Antibodies (Anti-Drug Antibodies [ADA])

13. Number of Participants With Specific Anti-Eptinezumab Antibodies for Neutralizing Activity (NAb)

1. Porcentaje de participantes con una reducción del 50 % desde el inicio en los MMD promediados durante las semanas 1 a 12

2. Porcentaje de participantes con migraña el día posterior a la dosificación (Día 1)

3. Cambio desde el inicio en MMD con el uso de medicación aguda promediado durante las semanas 1-12

4. Porcentaje de participantes con una reducción del 75 % desde el inicio en los MMD promediados durante las semanas 1 a 12

5. Porcentaje de participantes con una reducción del 75 % desde el inicio en los MMD promediados durante las semanas 1 a 4

6. Porcentaje de participantes con una reducción del 50 % desde el inicio en los MMD promediados durante las semanas 1 a 4

7. Cambio desde el inicio en los días de dolor de cabeza mensuales promediados durante las semanas 1-12

8. Cambio desde el inicio en la tasa de migrañas con intensidad de dolor severo promediado durante las semanas 1-12

9. Cambio desde el inicio en días con uso de medicación aguda promediado durante las semanas 1-12

10. Cambio desde el inicio en el puntaje del Cuestionario de evaluación de discapacidad por migraña pediátrica (PedMIDAS) promediado durante las semanas 1-12

11. Concentración plasmática de eptinezumab libre

12. Número de participantes con anticuerpos específicos antieptinezumab (Anti-Drug Antibodies
[ADA])

13. Número de participantes con anticuerpos específicos antieptinezumab para actividad neutralizante (NAb)

E.5.2.1

Timepoint(s) of evaluation of this end point

1. Time Frame: Baseline up to Weeks 1-12
2. Time Frame: Day 1
3. Time Frame: Baseline, Weeks 1-12
4. Time Frame: Baseline up to Weeks 1- 12
5. Time Frame: Baseline up to Weeks 1-4
6. Time Frame: Baseline up to Weeks 1-4
7. Time Frame: Baseline, Weeks 1-12
8. Time Frame: Baseline, Weeks 1-12
9. Time Frame: Baseline, Weeks 1-12
10. Time Frame: Baseline, Weeks 1-12
11. Time Frame: Randomization ( pre-dose [Week 0]), Week 8, Week 12, and safety follow up visit (Week 20)
12. Time Frame: From randomization (Week 0) up to Week 20
13. Time Frame: From randomization (Week 0) up to Week 20

1. Marco de tiempo: línea de base hasta las semanas 1-12
2. Marco de tiempo: Día 1
3. Marco de tiempo: línea de base, semanas 1-12
4. Marco de tiempo: línea de base hasta las semanas 1 a 12
5. Marco de tiempo: línea de base hasta las semanas 1-4
6. Marco de tiempo: línea de base hasta las semanas 1-4
7. Marco de tiempo: línea de base, semanas 1-12
8. Marco de tiempo: línea de base, semanas 1-12
9. Marco de tiempo: línea de base, semanas 1-12
10. Marco de tiempo: línea de base, semanas 1-12
11. Plazo: aleatorización (antes de la dosis [semana 0]), semana 8,
semana 12 y visita de seguimiento de seguridad (semana 20)
12. Plazo: desde la aleatorización (semana 0) hasta la semana 20
13. Plazo: desde la aleatorización (semana 0) hasta la semana 20

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

Yes

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

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)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

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

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

Argentina

Canada

Mexico

Serbia

Turkey

United States

Italy

Portugal

United Kingdom

Spain

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

The end of the study for an individual patient is defined as the last scheduled procedure shown in Panel 2 of the protocol. The overall end of the study is defined as the last scheduled procedure shown in Panel 2 of the protocol for the last patient in the study globally.

El final del estudio para un paciente individual se define como el último procedimiento programado que se muestra en el Panel 2 del protocolo. El final global del estudio se define como el último procedimiento programado que se muestra en el Panel 2 del protocolo para el último paciente del estudio a nivel mundial.

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

Yes

F.1.1

Number of subjects for this age range:

285

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)

Yes

F.1.1.6.1

Number of subjects for this age range:

285

F.1.2

Adults (18-64 years)

F.1.3

Elderly (>=65 years)

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

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

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

The patient has assented to participate in the study and the patient’s parent(s)/legal representative(s) have/has signed the Informed Consent Form prior to the conduct of any study-specific procedures.

El paciente ha firmado el asentimiento para participar en el estudio y los padres/representantes legales del paciente han firmado el Formulario de consentimiento informado antes de realizar cualquier procedimiento específico del estudio.

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

285

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)

Patients who complete this study may continue into the optional OLE study (19379A) if informed assent/consent has been obtained and the patient is deemed to be eligible, as judged by the investigator

Los pacientes que completan este estudio pueden continuar en el estudio opcional OLE (19379A) si se ha obtenido el asentimiento/consentimiento informado y se considera que el paciente es elegible, a juicio del investigador.

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

2022-06-24

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-06-20

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

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials