Clinical Trials Register

Summary
EudraCT Number:	2017-002397-39
Sponsor's Protocol Code Number:	20150125
National Competent Authority:	Poland - Office for Medicinal Products
Clinical Trial Type:	EEA CTA
Trial Status:	Trial now transitioned
Date on which this record was first entered in the EudraCT database:	2019-05-10
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

Poland - Office for Medicinal Products

A.2

EudraCT number

2017-002397-39

A.3

Full title of the trial

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to
Evaluate the Efficacy and Safety of Erenumab in Children (6 to < 12 Years) and Adolescents (12 to < 18 Years) With Episodic Migraine (OASIS PEDIATRIC [EM])

A.3.1

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

Efficacy and Safety of Erenumab in Pediatric Subjects with Episodic Migraine

A.4.1

Sponsor's protocol code number

20150125

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT03836040

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/370/2016

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Amgen Inc.
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	Amgen, Inc.
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	Amgen Biotechnologia Sp. z o.o.
B.5.2	Functional name of contact point	Medical Information
B.5.3	Address:
B.5.3.1	Street Address	ul. Pulawska 145
B.5.3.2	Town/ city	Warszawa
B.5.3.3	Post code	02-715
B.5.3.4	Country	Poland
B.5.4	Telephone number	+4822581 30 00
B.5.5	Fax number	+4822581 30 01
B.5.6	E-mail	Medinfo-pol@amgen.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	Aimovig
D.2.1.1.2	Name of the Marketing Authorisation holder	Novartis Europharm Limited
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	AMG 334 vials
D.3.2	Product code	AMG 334
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	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	erenumab
D.3.9.1	CAS number	1582205-90-0
D.3.9.2	Current sponsor code	AMG 334
D.3.9.3	Other descriptive name	AMG 334
D.3.9.4	EV Substance Code	SUB74690
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	70
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	Yes
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	Aimovig
D.2.1.1.2	Name of the Marketing Authorisation holder	Novartis Europharm Limited
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	AMG 334 PFS
D.3.2	Product code	AMG 334
D.3.4	Pharmaceutical form	Solution for injection in pre-filled syringe
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	erenumab
D.3.9.1	CAS number	1582205-90-0
D.3.9.2	Current sponsor code	AMG 334
D.3.9.3	Other descriptive name	AMG 334
D.3.9.4	EV Substance Code	SUB74690
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	70
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	Yes
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 injection
D.8.4	Route of administration of the placebo	Subcutaneous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Episodic migraine

E.1.1.1

Medical condition in easily understood language

Migraine

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 effect of erenumab compared with placebo on the change
in monthly migraine days (MMD) from baseline to week 9 through week 12 (month 3) of the double-blind treatment phase (DBTP).

E.2.2

Secondary objectives of the trial

To evaluate the effect of erenumab compared with placebo on the change in monthly headache days from baseline to week 9 through week 12 of the DBTP.
- To evaluate the effect of erenumab compared with placebo on the proportion of subjects with at least 50% reduction in MMDs from baseline to week 9 through week 12 of the DBTP.
- To evaluate the effect of erenumab compared with placebo on change in MMDs from baseline to the average of the first 3 months of the DBTP.
- To evaluate the effect of erenumab compared with placebo on change
in MMDs from baseline to the average of the 6-month DBTP.
- To evaluate the effect of erenumab compared with placebo on change
in monthly average severity of migraine attacks from baseline to week 9 through week 12 of the DBTP.
- To evaluate the effect of erenumab compared with placebo on change
in migraine-related disability and productivity as measured by the modified Pediatric Migraine Disability Assessment from baseline to month 3 of the DBTP

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

40-week optional dose-level-blinded extension phase (DLBEP),
during which all subjects will receive erenumab at the blinded dose level.

E.3

Principal inclusion criteria

101 Children (6 to < 12 years of age) or adolescent (12 to < 18 years of age) at the
time of signing, if developmentally appropriate, the formal assent to participate to the study.
102 Subject’s parent or legal representative has provided written informed consent before initiation of any study-specific activities/procedures.
103 History of migraine (with or without aura) for ≥ 12 months before screening
according to the IHS Classification ICHD-3 based on medical records and/or subject self-report or parents’ or legal representative’s report
104 History of < 15 headache days per month of which ≥ 4 headache days were
assessed by the subject as migraine days per month in each of the 3 months
prior to screening
105 Migraine frequency: . 4 and < 15 migraine days based on the eDiary
data during the last 28 days of the baseline phase if . 28 days in
duration.
106 Headache frequency: < 15 headache days based on the eDiary data
during the last 28 days of the baseline phase if . 28 days in duration.
107 Demonstrated at least 80% compliance with the eDiary based on the
last 28 days of the baseline period, if . 28 days in duration (eg,
completing eDiary items for at least 23 out of the last 28 days of the
baseline phase).

E.4

Principal exclusion criteria

201 History of cluster headache or hemiplegic migraine headache.
202 No therapeutic response with > 2 of the following 10 medication categories for prophylactic treatment of migraine after an adequate therapeutic trial
203 Malignancy within 5 years before screening.
204 History of suicidal behavior or the subject is at risk of self-harm or harm to others as evidenced by endorsement of items 4 or 5 on the pediatric Columbia-suicide Severity Rating Scale (C-SSRS) assessed at screening.
205 Evidence of drug or alcohol abuse or dependence within 12 months before
screening, based on medical records, subject self-report, or positive urine drug
test performed during screening
206 Human immunodeficiency virus (HIV) infection by history.
207 History of seizure disorder or other significant neurological disorder other than migraine. Note: a single childhood febrile seizure is not exclusionary.
208 History of major psychiatric disorder
209 Use of prohibited medication within 1 month before the start of the baseline
phase and/or during the baseline phase
210 Use of prohibited devices (such as stimulation devices) or procedures (such as acupuncture, biofeedback, relaxation techniques, or psychotherapy) with the goal of preventing migraines, within 3 months before the start of the baseline phase and/or during the baseline phase Note: Subjects who have discontinued CBT within 3 months prior to the
start of the baseline phase are eligible for the study provided that there
is evidence of CBT failure/lack of efficacy prior to initial screening (per
medical records or investigator's assessment)
211 Received botulinum toxin in the head and/or neck region within 4 months before the start of the baseline phase or during the baseline phase.
212 Received medication targeting the CGRP pathway within 4 months before the start of the baseline phase or during the baseline phase.
213 Taken the following for any indication in any month during the 2 months before the start of the baseline phase or during the baseline phase :
• Ergotamines or triptans on ≥ 10 days per month.
• Simple analgesics (nonsteroidal anti-inflammatory drugs [NSAIDs],
acetaminophen) on ≥ 15 days per month.
• Opioid or butalbital-containing analgesics on ≥ 4 days per month
214 Currently receiving treatment in another investigational device or drug study, or less than 90 days since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded
215 Subject has clinically significant vital signs, laboratory results, or ECG
abnormality during screening that, in the opinion of the investigator, could pose a risk to subject safety or interfere with the study evaluation.
216 Hepatic disease by history or total bilirubin (TBL) ≥ 2.0 x upper limit of normal (ULN) or alanine transaminase (ALT) or aspartate aminotransferase (AST)
≥ 3.0 x ULN, as assessed by the central laboratory at initial screening

E.5 End points

E.5.1

Primary end point(s)

Change from baseline in MMDs to week 9 through week 12 (month 3) of
the DBTP.

E.5.1.1

Timepoint(s) of evaluation of this end point

3 months

E.5.2

Secondary end point(s)

- Change from baseline in monthly headache days to week 9 through week 12 (month 3) of the DBTP
- Achievement of at least 50% reduction in MMDs from baseline to week 9 through week 12 (month 3) of the DBTP.
- Change from baseline in MMDs to the average of the first 3 months (week 1 through week 12) of the DBTP.
- Change from baseline in MMDs to the average of the 6-month DBTP (week 1 through week 24).
- Change from baseline in average monthly severity of migraine attacks to
week 9 through week 12 (month 3) of the DBTP.
- Change from baseline in migraine-related disability and productivity as measured by the modified PedMIDAS to month 3 of the DBTP.

E.5.2.1

Timepoint(s) of evaluation of this end point

3,6 months

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

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

Colombia

Switzerland

Canada

Russian Federation

United States

Belgium

Finland

Germany

Hungary

Poland

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

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.1.1.1

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)

Yes

F.1.1.5.1

Number of subjects for this age range:

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

376

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

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

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Subject's parent or legal representative may provide written informed consent

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

171

F.4.2.2

In the whole clinical trial

456

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)

12-week safety follow-up (16 weeks after the last dose of investigational product)

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

2019-08-01

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-05-15

P. End of Trial
P.	End of Trial Status	Trial now transitioned

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