Clinical trial NCT01859481: Eletriptan Provides Consistent Migraine Relief: Results Of A Within-Patient Multiple-Dose Study
Official title: A Multicentre, Dose Optimisation Study to Assess the Consistency of Efficacy of Eletriptan for the Treatment of Migraine (With and Without Aura)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine Without Aura
Migraine With Aura
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-05-22
Enrollment: 971
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluation of headache response at 2 hours for active treated attacks for increasing dose.


Eligibility criteria: Inclusion Criteria:

* Male and Female subjects in good general health, aged 18 to 65 years.
* Subjects should meet IHS diagnostic criteria for migraine with or without aura.
* Based on past history, subjects should expect to suffer at least one acute attack of migraine with or without aura, each 6 weeks

Exclusion Criteria:

* Known coronary-artery disease, clinically significant arrhythmia, heart failure, or uncontrolled hypertension.
* Pregnant or lactating women.
* Clinically significant electrocardiogram abnormalities at screening.

Primary outcomes:
measure: Consistency of headache response (3 responses out of 3 active treated attacks) . Headache response was defined as migraine headache pain of moderate or severe intensity pre dose becoming basent or mild within 2 hours post dose.
timeFrame: 24 weeks
Secondary outcomes:
measure: Consistency of headache response (2 responses out of 3 active treated attacks). Headache response was defined as migraine headache pain of moderate or severe intensity pre dose becoming basent or mild within 2 hours post dose.
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: Eeuwfeestkliniek
city: Brugge
country: Belgium
facility: A.Z. Sint Jan
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires St Luc
city: Charleroi
country: Belgium
facility: C.H.U. de Charleroi
city: Liege
country: Belgium
facility: Hopital de La Citadelle
city: Brno
country: Czechia
facility: Faculty Hospital U Svety Anny
city: Hradec Kralove
country: Czechia
facility: Neurologika Klinika F.N.
city: Prague 2
country: Czechia
facility: Pain Centrum
city: Prague 2
country: Czechia
facility: 1St Medical Faculty of the Charles University
city: Arhus C
country: Denmark
facility: Arhus Kommunehospital
city: Glostrup
country: Denmark
facility: Kas Glostrup
city: Odense C
country: Denmark
facility: Korsgaard, Anne G. (Private Practice)
city: Olstykke
country: Denmark
facility: Peter Staehr
city: Roskilde
country: Denmark
facility: Asbjorn Ziebel
city: Toulouse
country: France
facility: Hopital de Rangueil
state: Cedex 04
city: Toulouse
country: France
facility: Veyrie-Courtade
state: Tououse
city: Tours Cedex
country: France
facility: C.H.U.R Bretonneau
state: Tours
city: Altkirch
country: France
facility: Kubler Altkirch
city: Angouleme
country: France
facility: Marcombes Angouleme
city: Anzin
country: France
facility: Houdart Anzin
city: Bordeaux Cedex
country: France
facility: Groupe Pellegrin Tripode
city: Carcassonne
country: France
facility: Siboni Carcassonne
city: Colombes Cedex
country: France
facility: Hopital Louis Mourier
city: Laval
country: France
facility: Cormier Laval
city: Lille
country: France
facility: Hopital Salengro
city: Lyon Cedex 03
country: France
facility: Hopital Louis Pradel
city: Nice Cedex 1
country: France
facility: Hopital Pasteur
city: Orleans
country: France
facility: Private Practice
city: Paris Codex 14
country: France
facility: Hopital Cochin
city: Paris
country: France
facility: Delfiner Paris
city: Paris
country: France
facility: Hopital Lariboisiere
city: Reims
country: France
facility: Vaunaize Reims (Ds For Oc)
city: Reims
country: France
facility: Vaunaize Reims
city: Rouen
country: France
facility: Hopital Charles Nicolle
city: Saint Etienne Cedex 2
country: France
facility: Hospital Bellevue
city: Toulon
country: France
facility: Bouchacourt Toulon
city: Toulon
country: France
facility: Lemarquis Toulon
city: Voiron
country: France
facility: Mick Voiron
city: Berlin
country: Germany
facility: Private Practice
city: Berlin
country: Germany
facility: Private Practice
city: Bochum
country: Germany
facility: Private Practice (Guenther Schumann)
city: Bochum
country: Germany
facility: Private Practice
city: Eckernfoerde
country: Germany
facility: Private Practice
city: Goettingen
country: Germany
facility: Private Practice
city: Hamburg
country: Germany
facility: Private Practice
city: Oldenburg
country: Germany
facility: Private Practice
city: Schwendi
country: Germany
facility: Fachklinik Fuer Neurologie Dietenbronn Gmbh
city: Stade
country: Germany
facility: Private Practice (Dr. Renate Kreyer)
city: Souda
country: Greece
facility: Neurology Clinic of Chania
state: Chania,crete
city: Athens
country: Greece
facility: General Athens State Hospital
city: Thessaloniki
country: Greece
facility: Saint Dimitrios Hospital
city: Budapest
country: Hungary
facility: Peterfy Teaching Hospital
city: Budapest
country: Hungary
facility: Semmelweis University
city: Budapest
country: Hungary
facility: Szent-Imre Hospital
city: Budapest
country: Hungary
facility: Jahn Ferenc Hospital
city: Budapest
country: Hungary
facility: Uzsoki Hospital
city: Debrecen
country: Hungary
facility: University of Debrecen, Medical and Health Science Centre, Medical School
city: Debrecen
country: Hungary
facility: Kenezy County Hospital
city: Modena
country: Italy
facility: Universita Degli Studi Di Modena-Policlinico Dipartimento Di Medicina Interna
state: Emilia-romagna
city: Pavia
country: Italy
facility: Fondazione Istituto Neurologico Casimiro Mondino Istituto Di Ricovero E Cura A Carattere Scientifico
state: Lombardia
city: Bologna
country: Italy
facility: Universita' Di Bologna
city: Brescia
country: Italy
facility: Poliambulatorio Salus
city: Cagliari
country: Italy
facility: Universita' Degli Studi Di Cagliari - Presidio Osp.S.Giovanni Di Dio
city: Catania
country: Italy
facility: Azienda Vittorio Emanuele
city: L'aquila-coppito
country: Italy
facility: Clinica Neurologica
city: Messina
country: Italy
facility: Policlinico Universitario
city: Milano
country: Italy
facility: Centro Cefalee Irccs "C. Besta"
city: Padova
country: Italy
facility: Universita Di Padova
city: Parma
country: Italy
facility: Centro Cefalee
city: Perugia
country: Italy
facility: Clinica Neurologica, Universita Di Perugia
city: Pozzilli (isernia)
country: Italy
facility: Centro Cefalee - Neuromed
city: Roma
country: Italy
facility: Ospedale S. Eugenio
city: Torino
country: Italy
facility: Centro Cefalee
city: Torrette DI Ancona (AN)
country: Italy
facility: Ospedale Regionale Torrette
city: Trieste
country: Italy
facility: Ospedale Maggiore
city: Vicenza
country: Italy
facility: Ospedale S. Bortolo
city: 's-hertogenbosch
country: Netherlands
facility: Bosch Medicentrum (Locatie Willem Alexander Ziekenhuis)
city: Amsterdam
country: Netherlands
facility: Sint Lucas Andreas Ziekenhuis (Location: St.Lucas)
city: Apeldoorn
country: Netherlands
facility: Gelre Ziekenhuis (Location: Lukas)
city: Blaricum
country: Netherlands
facility: Ziekenhuis Gooi-Noord
city: Breda
country: Netherlands
facility: Ignatius Ziekenhuis Breda
city: EDE
country: Netherlands
facility: Gelderse Vallei Ziekenhuis
city: Emmen
country: Netherlands
facility: Scheperziekenhuis
city: Heerlen
country: Netherlands
facility: Atrium Heerlen
city: Hengelo (OV)
country: Netherlands
facility: St. Streekziekenhuis Midden Twente
city: Rotterdam
country: Netherlands
facility: Ikazia Ziekenhuis
city: Venray
country: Netherlands
facility: Sint Elisabeth Ziekenhuis
city: Zoetermeer
country: Netherlands
facility: Lage Land Ziekenhuis
city: Nordbyhagen
country: Norway
facility: Sentralsykehuset I Akershus
city: Oslo
country: Norway
facility: Volvat Medisinske Senter
city: Tonsberg
country: Norway
facility: Strandquist, Dr. Stein Bror
city: Almada
country: Portugal
facility: Hospital Garcia Da Orta
city: Coimbra
country: Portugal
facility: Centro Hospitalar de Coimbra
city: Porto
country: Portugal
facility: Hospital S.Joao
city: Sabadell
country: Spain
facility: Consorci Hospitalari Del Parc Tauli
state: Barcelona
city: Puerto Real
country: Spain
facility: Hospital Universitario de Puerto Real
state: Cadiz
city: Alcorcon
country: Spain
facility: Fundacion Hospital Alcorcon
state: Madrid
city: Galdakao
country: Spain
facility: Hospital de Galdakao
state: Vizcaya
city: Almeria
country: Spain
facility: Hospital Torrecardenas
city: Barcelona
country: Spain
facility: Hospital Del Sagrado Corazon
city: Barcelona
country: Spain
facility: Hospital General Universitari Vall D�Hebron
city: Burgos
country: Spain
facility: Hospital General Yag�
city: Ciudad Real
country: Spain
facility: Hospital Nuestra SE�Ra de Alarcos
city: Jaen
country: Spain
facility: Hospital Ciudad de Jaen
city: Lleida
country: Spain
facility: Hospital Universitari de Lleida Arnau de Vilanova
city: Madrid
country: Spain
facility: Hospital Ramon Y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario San Carlos
city: Malaga
country: Spain
facility: Hospital Virgen de La Victoria
city: Murcia
country: Spain
facility: Hospital General Universitario J. M. Morales Meseguer
city: Oviedo
country: Spain
facility: Hospital General de Asturias
city: San Sebastian
country: Spain
facility: Hospital Na Sa de Aranzazu
city: Sevilla
country: Spain
facility: Hospital Nuestra SE�Ra de Valme
city: Valencia
country: Spain
facility: Hospital Clinico Universitario La Fe
city: Valencia
country: Spain
facility: Hospital General Universitario
city: Fritsla
country: Sweden
facility: Fritsla Vardcentral
city: Goeteborg
country: Sweden
facility: Migranklinik-Goeteborg
city: Halmstad
country: Sweden
facility: Lanssjukhuset Halmstad
city: Halmstad
country: Sweden
facility: Viktoriakliniken
city: Helsingborg
country: Sweden
facility: Neurologsektionen, Lasarettet
city: Helsingborg
country: Sweden
facility: Neuro Kliniken, Helsingborg
city: Hoganas
country: Sweden
facility: Sjocrona Vardcentral
city: Huddinge
country: Sweden
facility: Huddinge Universitetssjukhus
city: Kista
country: Sweden
facility: Kistahalsan Ab
city: Lund
country: Sweden
facility: Lund Lakarmottagningen
city: Lund
country: Sweden
facility: Medicin Kliniken, Universitetssjukhuset
city: Malmo
country: Sweden
facility: Lakargruppen Gustaf Adolf
city: Marsta
country: Sweden
facility: Previa Ab Sigtunahalsan
city: Oxelosund
country: Sweden
facility: Oxelohalsan
city: Stockholm
country: Sweden
facility: Bankhalsan
city: Stockholm
country: Sweden
facility: Lakarhuset Odenplan
city: Stockholm
country: Sweden
facility: Ostermalmshalsan
city: Stockholm
country: Sweden
facility: St Gorans Sjukhus
city: Tyreso
country: Sweden
facility: Tyresohalsan Huslakare Ab (Ds For Oc)
city: Tyreso
country: Sweden
facility: Tyresohalsan Huslakare Ab
city: Vaexjoe
country: Sweden
facility: Kronobergskliniken
city: Vasteras
country: Sweden
facility: Centrallasarettet
city: Vastervik
country: Sweden
facility: Vasterviks Sjukhus
city: Ystad
country: Sweden
facility: Novakliniken
city: Adana
country: Turkey
facility: Cukurova University Medical Faculty
city: Trabzon
country: Turkey
facility: Karadeniz Technical University Medical Faculty
facility: Ahepa University Hospital
facility: Foretagshalsovarden Linden
facility: Huslakargruppen
facility: Limhamns Lakargrupp, Tarnan
facility: Medicinskt Centrum
facility: Sentralsjukehuset I Hedmark
facility: Sint Anna Ziekenhuis
facility: Vardcentralen
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Almas M, Tepper SJ, Landy S, Schweizer E, Ramos E. Consistency of eletriptan in treating migraine: Results of a randomized, within-patient multiple-dose study. Cephalalgia. 2014 Feb;34(2):126-35. doi: 10.1177/0333102413500726. Epub 2013 Aug 14.