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EUCTR2017-002397-39 | SNCTP000003394

Wirksamkeit und Sicherheit von Erenumab bei pädiatrischen Patienten mit episodischer 4 Migräne

Data source: BASEC (Imported from 09.12.2019), WHO (Imported from 01.12.2019)
Changed: 01.12.2019
Disease category: Hirnerkrankungen (nicht Krebs)

Brief description of trial (Source of data: BASEC)

Es handelt sich um eine multizentrische, randomisierte, doppelblinde, placebokontrollierte, Parallelgruppenstudie. Das in der Erprobung befindliche Studienmedikament heisst Erenumab. Erenumab wird von Amgen Inc., entwickelt. Erenumab wurde für die Behandlung von Migräne bei Erwachsenen in der Schweiz (am 13. Juli 2018), in den USA und Europa zugelassen. Die Behandlung von Kindern und Jugendlichen mit Erenumab wird derzeit jedoch noch geprüft. An dieser Studie werden insgesamt etwa 450 Personen (370 Jugendliche im Alter von 12 bis < 18 Jahren und 80 Kinder im Alter von 6 bis < 12 Jahren) aus rund 60 Spitäler/Einrichtungen in Nord- und Lateinamerika und Europa teilnehmen. In der Schweiz werden voraussichtlich 29 Patienten über einen Zeitraum von 3 Jahren in die Studie aufgenommen. Die Studie wird insgesamt etwa 4.5 Jahre dauern. Die gesamte Studiendauer für die einzelnen Teilnehmenden beträgt etwas mehr als 1.5 Jahre (83 Wochen).

Health conditions investigated (Source of data: BASEC)

Es soll untersucht werden, ob Erenumab bei Kindern und Jugendlichen Migräne verhindern kann und ob das Studienmedikament sicher und gut verträglich ist und ob es Nebenwirkungen verursacht. In dieser Studie wird zudem beurteilt, welche Dosen von Erenumab bei den Behandelten sicher und wirksam sind.

Health conditions (Source of data: WHO)

Episodic migraine
MedDRA version: 20.0 Level: PT Classification code 10027599 Term: Migraine System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Rare disease (Source of data: BASEC)

No

Intervention investigated (e.g. drug, therapy or campaign) (Source of data: BASEC)

Das Studienmedikament Erenumab wird einmal monatlich (alle 4 Wochen) in Form von 2 subkutanen (unter die Haut) Injektionen angewendet. Nur autorisierte Mitglieder des Studienpersonals am Studienzentrum dürfen das Studienmedikament verabreichen. Erenumab wird in dieser Studie in 3 Dosisstufen getestet: 35 mg, 70 mg und 140 mg.

Interventions (Source of data: WHO)


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

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

Criteria for participation in trial (Source of data: BASEC)

Folgende Einschlusskriterien gelten für Kinder und Jugendliche :

- Kinder im Alter von 6 bis < 12 Jahren oder Jugendliche im Alter von 12 bis < 18 Jahren
- Eine Krankheitsgeschichte von Migräne mit oder ohne Aura für ≥ 12 Monate
- über die drei Monate vor dem Screening (Voruntersuchung), durchschnittlich ≥ 4 Migränetage pro Monat
- ≥ 4 bis < 15 Migränetage und < 15 Tage mit Kopfschmerzen während der Vorlaufphase.

Exclusion criteria (Source of data: BASEC)

Folgende Ausschlusskriterien gelten:
- Krankheitsgeschichte mit Cluster Kopfschmerzen oder hemiplegischer Migräne.
- Keine therapeutische Reaktion mit >2 von 10 der Medikamentenkategorien für die prophylaktische Behandlung von Migräne nach einem angemessenen therapeutischen Versuch.
- Malignität innerhalb 5 Jahre vor dem Screening (Voruntersuchung).
- Selbstmörderisches Verhalten oder Verdacht die Versuchsperson könnte sich selber oder anderen Verletzungen zufügen.
- Beweise für Drogen- oder Alkoholmissbrauch/Abhängigkeit innerhalb 12 Monate vor dem Screening
-Krankheitsgeschichte von Infektion mit Humanem Immundefizienz-Virus (HIV)
- Krankheitsgeschichte mit Epilepsie oder anderen signifikanten neurologischen Störungen, außer Migräne
- Krankheitsgeschichte mit schweren psychischen Störungen oder aktuelle Beweise für schwere depressive Störungen
- Gebrauch von verbotenen Medikamenten und/oder medizinal Produkten
- hat innerhalb 4 Monate vor der Vorlaufphase Botulinum Toxin oder Medikamente erhalten/eingenommen die auf den "CGRP-Pathway" zielen
- Schwangerschaft oder geplante Schwangerschaft oder geplantes Stillen
Eine vollständige Liste der Eignungskriterien befindet sich im Studienprotokoll, Abschnitt 6.1 bis Abschnitt 6.2

Inclusion/Exclusion Criteria (Source of data: WHO)

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 during the baseline phase
based on the eDiary calculations.
106 Headache frequency: < 15 headache days during the baseline phase based on the eDiary calculations.
107 Demonstrated at least 80% compliance with the eDiary
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 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
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:
• 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

Further information on the trial in WHO primary registry

https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-002397-39

Further information on the trial from WHO database (ICTRP)

http://apps.who.int/trialsearch/Trial2.aspx?TrialID=EUCTR2017-002397-39-DE

Further information on trial

Date trial registered

27.03.2019

Incorporation of the first participant

06.08.2019

Recruitment status

Authorised-recruitment may be ongoing or finished

Academic title (Source of data: WHO)

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])

Type of trial (Source of data: WHO)

Interventional clinical trial of medicinal product

Design of the trial (Source of data: WHO)


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 (Source of data: WHO)

Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Primary end point (Source of data: WHO)

Timepoint(s) of evaluation of this end point: 3 months;
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 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
;
Main Objective: To evaluate the effect of erenumab compared with placebo on the change
in monthly migraine days (MMDs) from baseline to week 9 through week 12 (month 3) of the double-blind treatment phase (DBTP).

Secundary end point (Source of data: WHO)


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

Contact information (Source of data: WHO)

Amgen, Inc.

Trial sites

Trial sites in Switzerland (Source of data: BASEC)

Basel, Bern, Zollikon, Zürich

Countries (Source of data: WHO)

Belgium, Canada, Colombia, Finland, Germany, Hungary, Poland, Russian Federation, Switzerland, United Kingdom, United States

Contact for further information on the trial

Details of contact in Switzerland (Source of data: BASEC)

Matthias Langenfeld
+41 41 369 0245
mlangenf@amgen.com

Contact for general information (Source of data: WHO)

Medical Information
Riesstr. 24
Amgen GmbH
+498002643644
eudemedinf@amgen.com

Contact for scientific information (Source of data: WHO)

Medical Information
Riesstr. 24
Amgen GmbH
+498002643644
eudemedinf@amgen.com

Principal Sponsor/Investigator

Principal sponsor (Source of data: WHO)

Amgen Inc.

Further trial identification numbers

BASEC ID (Source of data: BASEC)

2019-00238

Secondary ID (Source of data: WHO)

20150125;2017-002397-39-GB