Study identification

EU PAS number

EUPAS35111

Study ID

35112

Official title and acronym

Pan European Prospective Observational Study of Fremanezumab effectiveness in patients with chronic or episodic migraine in the Real-World: PEARL study

DARWIN EU® study

No

Study countries

Czechia
Denmark
Finland
Greece
Italy
Norway
Portugal
Spain
Sweden
Switzerland
United Kingdom

Study description

This was a 45-month (21-month recruitment and 24-month follow-up), multicenter, multicountry (pan-European), prospective observational study to describe evidence of outcomes of fremanezumab treatment according to the SmPC in real-world clinical practice.
The study was aimed to address the impact of fremanezumab treatment in European real-world clinical practice and to generate information about real-world effectiveness, safety, tolerability, treatment adherence, and treatment persistence.
Primary endpoint: The proportion of patients reaching at least 50% reduction in the monthly average number of migraine days during the 6-month period after the first dose of fremanezumab.
Secondary effectiveness endpoints include mean change from baseline in MMD across months 1, 3, 6, 9, 12, 15, 18, 21, and 24, acute migraine medication use, and migraine-related disability scores.
Safety is evaluated based on adverse events (AEs) reported in clinical practice.

Study status

Finalised
Research institutions and networks

Institutions

INEP - Institut neuropsychiatrické péče

Thomayer Hospital

Motol University Hospital Prague

Nemocnice Jihlava

Neurologická klinika Olomouc

Vesctra Clinics s.r.o

Rigshospitalet Glostrup

University Hospital Odense, Hovedpineklinik

Southwest Jutland University Hospital

Pohjola Sairaala Oulu

Terveystalo Jyväskylä

Tampere University Hospital

Saaristokaupungin Lääkäriasema Oy

Helsinki University Hospital

Aeginition Hospital

ATTIKON University Hospital

401 Military Hospital Athens

Mediteraneo Hospital

Euromedica "Geniki Kliniki"

Aristotle University

IRCCS C. Mondino

SST Spedali Civili di Brescia

Ospedale Sant'Andrea

AOU Città della Salute e dela Scienza

Azienda Ospedaliero-Universitaria Modena

Ospedale SS Filippo e Nicola

POLICLINICO “PAOLO GIACCONE”

Azienda Ospedaliera "Pugliese - Ciaccio"

Ospedal S.Maria Della Misericordia

IRCCS Ospedale Policlinico San Martino

Sant'Anna University Hospital

IRCCS Istituto delle Scienze Neurologiche

IRCCS Neuromed

IRCCS San Raffaele

Università di Napoli Federico II of Naples

Azienda Ospedaliero-Universitaria Careggi

Headache Center, Via Roma 67, Pisa

IRCCS Carlo Besta Neurological Institute

Ospedale G.Moscati di Avellino

Istituto Auxologico San Luca

SITE CLOSED - Ospedale San Bortolo

Az. Ospedaliera Universitaria Bari

Clinica Neurologia AOU Policlinico San Marco Catania

Ospedale Santa Maria della Misericordia

AOU Ospedali Riuniti di Ancona

Campus Biomedico Roma

Az. Ospedaliera Universitaria Vanvitelli

Sapienza University of Rome Polo Pontino

Ospedale Cattinara-Ospedali Riuniti

Ospedale San Carlo Milano

Oslo Hodepinesenter AS

Sandvika Nevrosenter AS

Hodeverket Headache Clinic

Frisk Utvikling Helse AS

Hodepineklinikken

Hospital de Santa Maria, Lisboa

Hospital de Egas Moniz, Lisboa

Hospital Prof. Doutor Fernando Fonseca, Amadora

Hospital Universitario Vall d'Hebron

Hospital Universitary de Bellvitge

Hospital Clínico Universitario de Santiago

Hospital Universitario Virgen del Rocío

Hospital Universitario Virgen de Valme

Skåneuro AB, Lund

Stortorgets Neurologmottagning

St Görans Hospital Neuro Center

Rehdo AB, Göteborg

Läkarhuset Vällingby

VO Närsjukvård

Neurology Clinic Stockholm, Sophiahemmet, Box 5605

Neuroenheten Utsikten

Inselspital, University Hospital Bern

Kantonsspital St. Gallen

Neurologie am Löwenplatz

Cabinet de Neurologie, Sion, Valais

Ospedale Regionale di Lugano

Kopfwehzentrum Hirslanden AG

Hospitalier Universitaire Vaudois

RehaClinic Bad Zurzach

Luzerner Kantonsspital

Hôpital du Valais

Newcastle Acute Hospitals

Brighton and Sussex

Queens Medical Centre

King's College Hospital

St Thomas's Hospital

Hull University Teaching Hospitals

Contact details

Messoud Ashina 0000-0003-0951-5804

Primary lead investigator
ORCID number:
0000-0003-0951-5804

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Teva Pharmaceuticals Europe B.V.
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable