Eletriptan Provides Consistent Migraine Relief: Results Of A Within-Patient Multiple-Dose Study
NCT ID: NCT01859481
Last Updated: 2021-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
971 participants
INTERVENTIONAL
2000-03-31
2002-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Placebo
All subjects will receive open label eletriptan 40 mg per attack for the first three attacks in the phase 1 of the study. For the next 4 attacks subjects will be assigned to either eletriptan 40 mg or 80 mg group based on the response in the phase 1 portion of the study. In phase II, in each group subjects will receive eletriptan 40 mg or 80 mg for 3 attacks and placebo for 1 attack. In each group double-blind placebo will be inserted at random.
Eletriptan HBr 40 mg
Eletriptan HBr 40 mg
All subjects will receive open label eletriptan 40 mg per attack for the first three attacks in the phase 1 of the study. For the next 4 attacks subjects will be assigned to either eletriptan 40 mg or 80 mg group based on the response in the phase 1 portion of the study. In phase II, in each group subjects will receive eletriptan 40 mg or 80 mg for 3 attacks and placebo for 1 attack. In each group double-blind placebo will be inserted at random.
Eletriptan HBr 80 mg
Eletriptan HBr 80 mg
All subjects will receive open label eletriptan 40 mg per attack for the first three attacks in the phase 1 of the study. For the next 4 attacks subjects will be assigned to either eletriptan 40 mg or 80 mg group based on the response in the phase 1 portion of the study. In phase II, in each group subjects will receive eletriptan 40 mg or 80 mg for 3 attacks and placebo for 1 attack. In each group double-blind placebo will be inserted at random.
Interventions
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Placebo
All subjects will receive open label eletriptan 40 mg per attack for the first three attacks in the phase 1 of the study. For the next 4 attacks subjects will be assigned to either eletriptan 40 mg or 80 mg group based on the response in the phase 1 portion of the study. In phase II, in each group subjects will receive eletriptan 40 mg or 80 mg for 3 attacks and placebo for 1 attack. In each group double-blind placebo will be inserted at random.
Eletriptan HBr 40 mg
All subjects will receive open label eletriptan 40 mg per attack for the first three attacks in the phase 1 of the study. For the next 4 attacks subjects will be assigned to either eletriptan 40 mg or 80 mg group based on the response in the phase 1 portion of the study. In phase II, in each group subjects will receive eletriptan 40 mg or 80 mg for 3 attacks and placebo for 1 attack. In each group double-blind placebo will be inserted at random.
Eletriptan HBr 80 mg
All subjects will receive open label eletriptan 40 mg per attack for the first three attacks in the phase 1 of the study. For the next 4 attacks subjects will be assigned to either eletriptan 40 mg or 80 mg group based on the response in the phase 1 portion of the study. In phase II, in each group subjects will receive eletriptan 40 mg or 80 mg for 3 attacks and placebo for 1 attack. In each group double-blind placebo will be inserted at random.
Eligibility Criteria
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Inclusion Criteria
* 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
* Pregnant or lactating women.
* Clinically significant electrocardiogram abnormalities at screening.
18 Years
65 Years
ALL
Yes
Sponsors
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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Eeuwfeestkliniek
Antwerp, , Belgium
A.Z. Sint Jan
Bruges, , Belgium
Cliniques Universitaires St Luc
Brussels, , Belgium
C.H.U. de Charleroi
Charleroi, , Belgium
Hopital de La Citadelle
Liège, , Belgium
Faculty Hospital U Svety Anny
Brno, , Czechia
Neurologika Klinika F.N.
Hradec Králové, , Czechia
Pain Centrum
Prague, , Czechia
1St Medical Faculty of the Charles University
Prague, , Czechia
Arhus Kommunehospital
Arhus C, , Denmark
Kas Glostrup
Glostrup Municipality, , Denmark
Korsgaard, Anne G. (Private Practice)
Odense C, , Denmark
Asbjorn Ziebel
Roskilde, , Denmark
Peter Staehr
Ølstykke, , Denmark
Hopital de Rangueil
Toulouse, Cedex 04, France
Veyrie-Courtade
Toulouse, Tououse, France
C.H.U.R Bretonneau
Tours, Tours, France
Kubler Altkirch
Altkirch, , France
Marcombes Angouleme
Angoulême, , France
Houdart Anzin
Anzin, , France
Groupe Pellegrin Tripode
Bordeaux, , France
Siboni Carcassonne
Carcassonne, , France
Hopital Louis Mourier
Colombes, , France
Cormier Laval
Laval, , France
Hopital Salengro
Lille, , France
Hopital Louis Pradel
Lyon, , France
Hopital Pasteur
Nice, , France
Private Practice
Orléans, , France
Delfiner Paris
Paris, , France
Hopital Lariboisiere
Paris, , France
Hopital Cochin
Paris Codex 14, , France
Vaunaize Reims (Ds For Oc)
Reims, , France
Vaunaize Reims
Reims, , France
Hopital Charles Nicolle
Rouen, , France
Hospital Bellevue
Saint-Etienne, , France
Bouchacourt Toulon
Toulon, , France
Lemarquis Toulon
Toulon, , France
Mick Voiron
Voiron, , France
Private Practice
Berlin, , Germany
Private Practice
Berlin, , Germany
Private Practice (Guenther Schumann)
Bochum, , Germany
Private Practice
Bochum, , Germany
Private Practice
Eckernförde, , Germany
Private Practice
Göttingen, , Germany
Private Practice
Hamburg, , Germany
Private Practice
Oldenburg, , Germany
Fachklinik Fuer Neurologie Dietenbronn Gmbh
Schwendi, , Germany
Private Practice (Dr. Renate Kreyer)
Stade, , Germany
Neurology Clinic of Chania
Soúda, Chania,crete, Greece
General Athens State Hospital
Athens, , Greece
Saint Dimitrios Hospital
Thessaloniki, , Greece
Peterfy Teaching Hospital
Budapest, , Hungary
Semmelweis University
Budapest, , Hungary
Szent-Imre Hospital
Budapest, , Hungary
Jahn Ferenc Hospital
Budapest, , Hungary
Uzsoki Hospital
Budapest, , Hungary
University of Debrecen, Medical and Health Science Centre, Medical School
Debrecen, , Hungary
Kenezy County Hospital
Debrecen, , Hungary
Universita Degli Studi Di Modena-Policlinico Dipartimento Di Medicina Interna
Modena, Emilia-Romagna, Italy
Fondazione Istituto Neurologico Casimiro Mondino Istituto Di Ricovero E Cura A Carattere Scientifico
Pavia, Lombardy, Italy
Universita' Di Bologna
Bologna, , Italy
Poliambulatorio Salus
Brescia, , Italy
Universita' Degli Studi Di Cagliari - Presidio Osp.S.Giovanni Di Dio
Cagliari, , Italy
Azienda Vittorio Emanuele
Catania, , Italy
Clinica Neurologica
L'aquila-coppito, , Italy
Policlinico Universitario
Messina, , Italy
Centro Cefalee Irccs "C. Besta"
Milan, , Italy
Universita Di Padova
Padua, , Italy
Centro Cefalee
Parma, , Italy
Clinica Neurologica, Universita Di Perugia
Perugia, , Italy
Centro Cefalee - Neuromed
Pozzilli (isernia), , Italy
Ospedale S. Eugenio
Roma, , Italy
Centro Cefalee
Torino, , Italy
Ospedale Regionale Torrette
Torrette DI Ancona (AN), , Italy
Ospedale Maggiore
Trieste, , Italy
Ospedale S. Bortolo
Vicenza, , Italy
Bosch Medicentrum (Locatie Willem Alexander Ziekenhuis)
's-Hertogenbosch, , Netherlands
Sint Lucas Andreas Ziekenhuis (Location: St.Lucas)
Amsterdam, , Netherlands
Gelre Ziekenhuis (Location: Lukas)
Apeldoorn, , Netherlands
Ziekenhuis Gooi-Noord
Blaricum, , Netherlands
Ignatius Ziekenhuis Breda
Breda, , Netherlands
Gelderse Vallei Ziekenhuis
Ede, , Netherlands
Scheperziekenhuis
Emmen, , Netherlands
Atrium Heerlen
Heerlen, , Netherlands
St. Streekziekenhuis Midden Twente
Hengelo (OV), , Netherlands
Ikazia Ziekenhuis
Rotterdam, , Netherlands
Sint Elisabeth Ziekenhuis
Venray, , Netherlands
Lage Land Ziekenhuis
Zoetermeer, , Netherlands
Sentralsykehuset I Akershus
Nordbyhagen, , Norway
Volvat Medisinske Senter
Oslo, , Norway
Strandquist, Dr. Stein Bror
Tønsberg, , Norway
Hospital Garcia Da Orta
Almada, , Portugal
Centro Hospitalar de Coimbra
Coimbra, , Portugal
Hospital S.Joao
Porto, , Portugal
Consorci Hospitalari Del Parc Tauli
Sabadell, Barcelona, Spain
Hospital Universitario de Puerto Real
Puerto Real, Cadiz, Spain
Fundacion Hospital Alcorcon
Alcorcón, Madrid, Spain
Hospital de Galdakao
Galdakao, Vizcaya, Spain
Hospital Torrecardenas
Almería, , Spain
Hospital Del Sagrado Corazon
Barcelona, , Spain
Hospital General Universitari Vall D�Hebron
Barcelona, , Spain
Hospital General Yag�
Burgos, , Spain
Hospital Nuestra SE�Ra de Alarcos
Ciudad Real, , Spain
Hospital Na Sa de Aranzazu
Donostia / San Sebastian, , Spain
Hospital Ciudad de Jaen
Jaén, , Spain
Hospital Universitari de Lleida Arnau de Vilanova
Lleida, , Spain
Hospital Ramon Y Cajal
Madrid, , Spain
Hospital Universitario San Carlos
Madrid, , Spain
Hospital Virgen de La Victoria
Málaga, , Spain
Hospital General Universitario J. M. Morales Meseguer
Murcia, , Spain
Hospital General de Asturias
Oviedo, , Spain
Hospital Nuestra SE�Ra de Valme
Seville, , Spain
Hospital Clinico Universitario La Fe
Valencia, , Spain
Hospital General Universitario
Valencia, , Spain
Fritsla Vardcentral
Fritsla, , Sweden
Migranklinik-Goeteborg
Gothenburg, , Sweden
Lanssjukhuset Halmstad
Halmstad, , Sweden
Viktoriakliniken
Halmstad, , Sweden
Neurologsektionen, Lasarettet
Helsingborg, , Sweden
Neuro Kliniken, Helsingborg
Helsingborg, , Sweden
Sjocrona Vardcentral
Höganäs, , Sweden
Huddinge Universitetssjukhus
Huddinge, , Sweden
Kistahalsan Ab
Kista, , Sweden
Lund Lakarmottagningen
Lund, , Sweden
Medicin Kliniken, Universitetssjukhuset
Lund, , Sweden
Lakargruppen Gustaf Adolf
Malmo, , Sweden
Previa Ab Sigtunahalsan
Märsta, , Sweden
Oxelohalsan
Oxelösund, , Sweden
Bankhalsan
Stockholm, , Sweden
Lakarhuset Odenplan
Stockholm, , Sweden
Ostermalmshalsan
Stockholm, , Sweden
St Gorans Sjukhus
Stockholm, , Sweden
Tyresohalsan Huslakare Ab (Ds For Oc)
Tyreso, , Sweden
Tyresohalsan Huslakare Ab
Tyreso, , Sweden
Kronobergskliniken
Vaxjo, , Sweden
Centrallasarettet
Västerås, , Sweden
Vasterviks Sjukhus
Västervik, , Sweden
Novakliniken
Ystad, , Sweden
Cukurova University Medical Faculty
Adana, , Turkey (Türkiye)
Karadeniz Technical University Medical Faculty
Trabzon, , Turkey (Türkiye)
Ahepa University Hospital
, ,
Foretagshalsovarden Linden
, ,
Huslakargruppen
, ,
Limhamns Lakargrupp, Tarnan
, ,
Medicinskt Centrum
, ,
Sentralsjukehuset I Hedmark
, ,
Sint Anna Ziekenhuis
, ,
Vardcentralen
, ,
Countries
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References
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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.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A1601015
Identifier Type: -
Identifier Source: org_study_id
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