A 12-month Prospective, Randomized, Interventional, Global, Multi-center, Active-controlled Study Comparing Sustained Benefit of Two Treatment Paradigms (AMG334 qm vs. Oral Prophylactics) in Adult Episodic Migraine Patients

Who is this study for? Patients with Episodic Migraine
What treatments are being studied? Oral Prophylactic
Status: Completed
Location: See all (103) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

The purpose of this study is to compare the sustained long-term benefit between two treatment paradigms of migraine prophylactic agents (erenumab versus a control arm of oral prophylactics) in episodic migraine patients who have previously failed 1 to 2 prophylactic migraine treatments.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Written informed consent must be obtained before any assessment is performed.

• Adults greater than or equal to 18 years of age upon entry into screening.

• Documented history of migraine (with or without aura) greater than or equal to 12 months prior to screening according to the International Classification of Headache Disorders-3rd Edition (ICHD-3).

• Greater than or equal to 4 and less than 15 days per month of migraine symptoms (based on ICHD-3 criteria) on average across 3 months prior to screening based on retrospective reporting.

• Less than 15 days per month of headache symptoms (i.e., migraine and non-migraine).

• Subjects in need for switching by documented failure of 1 or 2 prophylactic treatments in the last 6 months due to either lack of efficacy or poor tolerability. For subjects with 1 prior treatment failure, the failure should have occurred in the last 6 months. For subjects with 2 prior treatment failures, the second treatment failure should have occurred in the last 6 months.

• During baseline: Confirmed migraine frequency of 4 to 14 migraine days and less than 15 days of headache symptoms.

• During baseline: greater than or equal to 80% compliance with the headache diary.

Locations
United States
California
Stanford Headache Center
Stanford
Connecticut
Yale Center for Clinical Research
New Haven
New England Institute for Neurology and Headache
Stamford
Washington, D.c.
George Washington Hospital
Washington
Florida
University of Miami Headache Division
Miami
Premier Research Institute
West Palm Beach
Illinois
Diamond Headache Clinic
Chicago
Robbins Headache Clinic
Riverwoods
Massachusetts
Medvadis
Watertown
New England Regional Headache Center, Inc
Worcester
Michigan
MHNI
Ann Arbor
Minnesota
Clinical Research Institute
Minneapolis
Missouri
Mercy Health Research
Saint Louis
Study Metrix Research
Saint Peters
Mississippi
The Headache Center
Ridgeland
New York
Laszlo Mechtler
Amherst
Pennsylvania
Jefferson Headache Center
Philadelphia
Tennessee
Nashville Neuroscience Group
Nashville
Texas
Texas Neurology
Dallas
Texas Institute for Neurological Disorders
Sherman
Other Locations
Argentina
IDIM Instituto de Investigaciones Metabolicas
Buenos Aires
Mautalen Salud e Investigacion
Ciudad Autonoma De Bs As
Centro Medico Privado en Reumatologia
Tucuman
Austria
Univ. Klinik fuer Neurologie
Innsbruck
Ordensklinikum Linz Barmherzigen Schwestern
Linz
Univ Klinik fuer AKH
Vienna
Belgium
AZ Sint Jan
Brugge
UZ Brussel
Brussel
UZ Gent
Gent
Jessa Ziekenhuis- Campus Virga Jesse Dienst Gastro-entrologie
Hasselt
Centre Hospitalier Regional de la Citadelle
Liege
Heilig Hart Ziekenhuis Lier
Lier
Finland
Laakarikeskus Aava Itakeskus
Helsinki
Terveystalo Ruoholahti
Helsinki
Terveystalo Pulssi
Turku
France
CHRU de LILLE
Lille Cedex
Hopital Lariboisiere Centre d Urgence des Cephalees
Paris Cedex 10
Hopital Charles Nicolle Departement de Neurologie
Rouen
CH Yves Le Foll
Saint Brieuc
CHU St Etienne Hopital Nord Bat A
Saint Etienne Cedex 2
Germany
GP Dept of Neurology
Bochum
Neurologische Gemeinschaftspraxis Klemt & Bauersachs
Dortmund
Neurologische Gemeinschaftpraxis im Bienenkorbhaus
Frankfurt
AmBeNet Hausarztpraxis
Leipzig
Medamed GmbH Studienambulanz
Leipzig
Greece
401 Army General Hospital of Athens Main Centre
Athens
Aeginition Hospital of Athens, University of Athens
Athens
Navy Hospital of Athens NNA Main Centre
Athens
Neurologicka Ambulancia Konzilium s r o
Athens
MEDITERRANEO Hospital
Glyfada
General Hospital of Patra O AGIOS ANDREAS Neurology Clinic
Patra
Euromedica General Clinic of Thessaloniki Neurology Dept
Thessaloniki
Ireland
Bon Secours Hospital
Cork
Beaumont Hospital
Dublin 9
Israel
Hillel Yaffe MC
Hadera
Rambam Medical Center
Haifa
Laniado
Netanya
Sheba MC
Ramat Gan
Tel Aviv Sourasky Medical Center Ichilov
Tel Aviv
Italy
Ospedali Riuniti Torrette di Ancona
Ancona
ASST degli Spedali Civili di Brescia Univ degli Studi
Brescia
A O Perugia Osp S Maria Misericordia Loc S Andrea d Fratte
Perugia
Azienda Ospedaliera Sant'Andrea - Università La Sapienza
Roma
IRCCS San Raffaele Pisana
Roma
Policl.Universit.Campus Bio-Medico Università Campus Bio-Med U.O.C.Area di Oncologia Medica
Roma
Netherlands
Zuyderland Medisch Centrum
Geleen
Martini Ziekenhuis
Groningen
Canisius Wilhelmina Hospital Dept of Neurology C-70
Nijmegen
Isala Ziekenhuis
Zwolle
Poland
Centrum Leczenia Padaczki i Migreny
Krakow
Gabient Lekarski Jacek Rozniecki
Lodz
ETG Warszawa
Warszawa
OHA MED Sp zo o
Warszawa
Wojskowy Instutyt Medyczny CSK MON
Warszawa
Portugal
Hospital Garcia de Orta EPE
Almada
Hospital da Luz
Lisboa
Hospital Santa Maria
Lisboa
Hospital Pedro Hispano Matosinhos E P E
Matosinhos
Centro Hospitalar do Porto Hospital Geral de Santo Antonio Serviço de Neurologia
Porto
Slovakia
MUDr Beata Dupejova s r o
Banska Bystrica
Nemocnica sv Michala a s
Bratislava
Nemocnica Komarno s r o
Komarno
Neurologicke oddelenie VNsP Levoca
Levoca
Neurolog odd NsP Liptovsky Mikulas
Liptovsky Mikulas
Neurologicka a algeziologicka ambulancia SANERA s r o
Presov
Spain
Hospital Vall D'Hebron
Barcelona
Hospital La Paz
Madrid
Hospital Quiron Madrid
Pozuelo De Alarcon
Hospital Marques de Valdecilla
Santander
Hospital Clinico Universitario de Santiago
Santiago De Compostela
Hospital Universitario Virgen del Rocio
Sevilla
Hospital Clinico Universitario Valencia
Valencia
Hospital Clinico Universitario de Valladolid
Valladolid
Hospital Clinico Universitario Lozano Blesa
Zaragoza
United Kingdom
Queen Elizabeth Hospital Pharmacy Dept.
Edgbaston
Glasgow Clinical Research Facility
Glasgow
The John Radcliffe Hospital
Headington
Hull and amp East Yorkshire Hospitals NHS Trust
Hull
King's College Hospital London
London
St Thomas Hospital
London
Royal Victoria Infirmary
Newcastile Upon Tyne
Salford Royal Hospital
Salford
University Hospital of North Midlands NHS Trust
Stoke On Trent
Time Frame
Start Date: 2019-05-15
Completion Date: 2022-09-30
Participants
Target number of participants: 621
Treatments
Experimental: AMG334 70 mg/140 mg
Participants were randomized to receive 70 mg or 140 mg of AMG334 as a subcutaneous injection once per month for 52 weeks in the Core Phase.~Participants were permitted to switch to an approved oral prophylactic based on treatment failure status and at the investigator's and participant's discretion.~Participants who completed visits through Week 52 of the Core Phase were eligible to participate in the 52-week Extension Phase of the study.
Active_comparator: Oral Prophylactic
Participants were randomized to receive a standard of care (SOC) locally approved oral prophylactic migraine medication once per day for 52 weeks in the Core Phase, as prescribed per local country labels.~Participants were permitted to switch to a different approved oral prophylactic based on treatment failure status and at the investigator's and participant's discretion.~Participants who completed visits through Week 52 of the Core Phase were eligible to participate in the 52-week Extension Phase of the study.
Related Therapeutic Areas
Sponsors
Leads: Amgen
Collaborators: Novartis

This content was sourced from clinicaltrials.gov