Efficacy and Safety of Erenumab in Pediatric Subjects with Episodic Migraine

• Register: EUCTR
• Last refreshed on: 12 December 2023
• Main ID: EUCTR2017-002397-39-DE
• Date of registration: 27/03/2019
• Prospective Registration: Yes
• Primary sponsor: Amgen Inc.
• Public title: Efficacy and Safety of Erenumab in Pediatric Subjects with Episodic Migraine
• Scientific title: 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])
• Date of first enrolment: 06/08/2019
• Target sample size: 456
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-002397-39
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 4
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Belgium, Canada, Colombia, Finland, Germany, Hungary, Italy, Japan, Poland, Portugal, Russian Federation, Spain, United Kingdom, United States

Contacts

• Name: Medical Information
• Affiliation: Amgen GmbH

• Name: Medical Information
• Affiliation: Amgen GmbH

Key inclusion & exclusion criteria

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 (Headache
Classification Committee of the International Headache Society, 2013)
based on medical records and/or subject self-report or parents' or legal
representative's report.
The following ICHD-3 specifications for pediatric migraine (subjects
aged < 18 years), should be considered for the diagnosis of migraine:
• Attacks may last 2 to 72 hours.
• Migraine headache is more often bilateral than in adults; unilateral
pain usually emerges in late adolescence or early adult life.
• Migraine headache is usually frontotemporal. Occipital headache in
children is rare and calls for diagnostic caution.
• A subset of otherwise typical subjects have facial location of pain,
which is called 'facial migraine' in the literature; there is no evidence
that these subjects form a separate subgroup of migraine subjects.
• In young children, photophobia and phonophobia may be inferred from
their behaviour.
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 (refer to Section 5.6 for definition of
migraine day).
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).
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 15 days 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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Episodic migraine
MedDRA version: 20.0 Level: PT Classification code 10027599 Term: Migraine System Organ Class: 10029205 - Nervous system disorders

Intervention(s)

Trade Name: Aimovig
Product Name: AMG 334 vials
Product Code: AMG 334
Pharmaceutical Form: Solution for injection
INN or Proposed INN: erenumab
CAS Number: 1582205-90-0
Current Sponsor code: AMG 334
Other descriptive name: AMG 334
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 70-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Trade Name: Aimovig
Product Name: AMG 334 PFS
Product Code: AMG 334
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: erenumab
CAS Number: 1582205-90-0
Current Sponsor code: AMG 334
Other descriptive name: AMG 334
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 70-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Main Objective: 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).

Primary end point(s): Change from baseline in MMDs to week 9 through week 12 (month 3) of
the DBTP.

Secondary Objective: - 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 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 week
9 through week 12 (month 3) of the DBTP

Timepoint(s) of evaluation of this end point: 3 months

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 3,6 months

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 monthly average 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 week 9 through week 12 (month
3) of the DBTP.

Secondary ID(s)

NCT03836040

20150125

2017-002397-39-GB

2023-504930-23

Source(s) of Monetary Support

Amgen, Inc.

Ethics review

Status: Approved
Approval date: 16/07/2019
Contact: