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Eletriptan Provides Consistent Migraine Relief: Results Of A Within-Patient Multiple-Dose Study

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Migraine Without Aura; Migraine With Aura

Intervention: Placebo (Drug); Eletriptan HBr 40 mg (Drug); Eletriptan HBr 80 mg (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Summary

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

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: 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.

Secondary outcome: 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.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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.

Locations and Contacts

Eeuwfeestkliniek, Antwerpen 2018, Belgium

A.Z. Sint Jan, Brugge 8000, Belgium

Cliniques Universitaires St Luc, Bruxelles 1200, Belgium

C.H.U. de Charleroi, Charleroi 6000, Belgium

Hopital de La Citadelle, Liege 4000, Belgium

Faculty Hospital U Svety Anny, Brno 65691, Czech Republic

Neurologika Klinika F.N., Hradec Kralove 50005, Czech Republic

1St Medical Faculty of the Charles University, Prague 2 12000, Czech Republic

Pain Centrum, Prague 2 12 850, Czech Republic

Arhus Kommunehospital, Arhus C 8000, Denmark

Kas Glostrup, Glostrup 2600, Denmark

Korsgaard, Anne G. (Private Practice), Odense C 5000, Denmark

Peter Staehr, Olstykke 3650, Denmark

Asbjorn Ziebel, Roskilde 4000, Denmark

Kubler Altkirch, Altkirch 68130, France

Marcombes Angouleme, Angouleme 16000, France

Houdart Anzin, Anzin 59416, France

Groupe Pellegrin Tripode, Bordeaux Cedex 33076, France

Siboni Carcassonne, Carcassonne 11000, France

Hopital Louis Mourier, Colombes Cedex 92701, France

Cormier Laval, Laval 53000, France

Hopital Salengro, Lille 59037, France

Hopital Louis Pradel, Lyon Cedex 03 69394, France

Hopital Pasteur, Nice Cedex 1 06200, France

Private Practice, Orleans 45000, France

Hopital Cochin, Paris Codex 14 75679, France

Delfiner Paris, Paris 75015, France

Hopital Lariboisiere, Paris 75475, France

Vaunaize Reims, Reims 51100, France

Vaunaize Reims (Ds For Oc), Reims 51100, France

Hopital Charles Nicolle, Rouen 76031, France

Hospital Bellevue, Saint Etienne Cedex 2 42055, France

Bouchacourt Toulon, Toulon 83 000, France

Lemarquis Toulon, Toulon 83000, France

Mick Voiron, Voiron 38500, France

Private Practice, Berlin 12687, Germany

Private Practice, Berlin 10117, Germany

Private Practice, Bochum 44807, Germany

Private Practice (Guenther Schumann), Bochum 44805, Germany

Private Practice, Eckernfoerde 24340, Germany

Private Practice, Goettingen 37073, Germany

Private Practice, Hamburg 22149, Germany

Private Practice, Oldenburg 26131, Germany

Fachklinik Fuer Neurologie Dietenbronn Gmbh, Schwendi 88475, Germany

Private Practice (Dr. Renate Kreyer), Stade 21680, Germany

General Athens State Hospital, Athens GR 156 69, Greece

Saint Dimitrios Hospital, Thessaloniki GR 546 34, Greece

Ahepa University Hospital, Unknown, Greece

Jahn Ferenc Hospital, Budapest 1201, Hungary

Peterfy Teaching Hospital, Budapest 1076, Hungary

Semmelweis University, Budapest 1083, Hungary

Szent-Imre Hospital, Budapest 1115, Hungary

Uzsoki Hospital, Budapest 1426, Hungary

Kenezy County Hospital, Debrecen 4034, Hungary

University of Debrecen, Medical and Health Science Centre, Medical School, Debrecen 4012, Hungary

Universita' Di Bologna, Bologna 40123, Italy

Poliambulatorio Salus, Brescia 25100, Italy

Universita' Degli Studi Di Cagliari - Presidio Osp.S.Giovanni Di Dio, Cagliari 09124, Italy

Azienda Vittorio Emanuele, Catania 95100, Italy

Clinica Neurologica, L'aquila-coppito 67100, Italy

Policlinico Universitario, Messina 98125, Italy

Centro Cefalee Irccs "C. Besta", Milano 20133, Italy

Universita Di Padova, Padova 35128, Italy

Centro Cefalee, Parma 43100, Italy

Clinica Neurologica, Universita Di Perugia, Perugia 06126, Italy

Centro Cefalee - Neuromed, Pozzilli (isernia) 86077, Italy

Ospedale S. Eugenio, Roma 00100, Italy

Centro Cefalee, Torino 10126, Italy

Ospedale Regionale Torrette, Torrette Di Ancona (an) 60020, Italy

Ospedale Maggiore, Trieste 34126, Italy

Ospedale S. Bortolo, Vicenza 36100, Italy

Bosch Medicentrum (Locatie Willem Alexander Ziekenhuis), 's-hertogenbosch 5223GV, Netherlands

Sint Lucas Andreas Ziekenhuis (Location: St.Lucas), Amsterdam 1061 AE, Netherlands

Gelre Ziekenhuis (Location: Lukas), Apeldoorn 7334 DZ, Netherlands

Ziekenhuis Gooi-Noord, Blaricum 1261 AN, Netherlands

Ignatius Ziekenhuis Breda, Breda 4818 CK, Netherlands

Gelderse Vallei Ziekenhuis, EDE 6711 PV, Netherlands

Scheperziekenhuis, Emmen 7824 AA, Netherlands

Atrium Heerlen, Heerlen 6419 PC, Netherlands

St. Streekziekenhuis Midden Twente, Hengelo (ov) 7555DL, Netherlands

Ikazia Ziekenhuis, Rotterdam 3083 AN, Netherlands

Sint Anna Ziekenhuis, Unknown, Netherlands

Sint Elisabeth Ziekenhuis, Venray 5801 CE, Netherlands

Lage Land Ziekenhuis, Zoetermeer 2725 NA, Netherlands

Sentralsykehuset I Akershus, Nordbyhagen 1474, Norway

Volvat Medisinske Senter, Oslo 0303, Norway

Strandquist, Dr. Stein Bror, Tonsberg 3111, Norway

Sentralsjukehuset I Hedmark, Unknown, Norway

Hospital Garcia Da Orta, Almada 2800, Portugal

Centro Hospitalar de Coimbra, Coimbra 3000, Portugal

Hospital S.Joao, Porto 4000, Portugal

Hospital Torrecardenas, Almeria 04009, Spain

Hospital Del Sagrado Corazon, Barcelona 08029, Spain

Hospital General Universitari Vall D�Hebron, Barcelona 08035, Spain

Hospital General Yag�, Burgos 09005, Spain

Hospital Nuestra SE�Ra de Alarcos, Ciudad Real 13002, Spain

Hospital Ciudad de Jaen, Jaen 23007, Spain

Hospital Universitari de Lleida Arnau de Vilanova, Lleida 25198, Spain

Hospital Ramon Y Cajal, Madrid 28034, Spain

Hospital Universitario San Carlos, Madrid 28040, Spain

Hospital Virgen de La Victoria, Malaga 29010, Spain

Hospital General Universitario J. M. Morales Meseguer, Murcia 30008, Spain

Hospital General de Asturias, Oviedo 33006, Spain

Hospital Na Sa de Aranzazu, San Sebastian 20014, Spain

Hospital Nuestra SE�Ra de Valme, Sevilla 41014, Spain

Hospital Clinico Universitario La Fe, Valencia 46009, Spain

Hospital General Universitario, Valencia 46014, Spain

Fritsla Vardcentral, Fritsla 510 29, Sweden

Migranklinik-Goeteborg, Goeteborg SE-411 17, Sweden

Lanssjukhuset Halmstad, Halmstad 301 85, Sweden

Viktoriakliniken, Halmstad 30246, Sweden

Neuro Kliniken, Helsingborg, Helsingborg 25221, Sweden

Neurologsektionen, Lasarettet, Helsingborg 251 87, Sweden

Sjocrona Vardcentral, Hoganas 263 26, Sweden

Huddinge Universitetssjukhus, Huddinge, Sweden

Kistahalsan Ab, Kista 164 40, Sweden

Lund Lakarmottagningen, Lund 221 21, Sweden

Medicin Kliniken, Universitetssjukhuset, Lund 22185, Sweden

Lakargruppen Gustaf Adolf, Malmo 211 36, Sweden

Previa Ab Sigtunahalsan, Marsta 195 30, Sweden

Oxelohalsan, Oxelosund 613 30, Sweden

Bankhalsan, Stockholm 105 34, Sweden

Lakarhuset Odenplan, Stockholm 113 22, Sweden

Ostermalmshalsan, Stockholm 11486, Sweden

St Gorans Sjukhus, Stockholm SE-112 81, Sweden

Tyresohalsan Huslakare Ab, Tyreso 135 21, Sweden

Tyresohalsan Huslakare Ab (Ds For Oc), Tyreso 135 21, Sweden

Foretagshalsovarden Linden, Unknown 392 31, Sweden

Huslakargruppen, Unknown, Sweden

Limhamns Lakargrupp, Tarnan, Unknown 216 16, Sweden

Medicinskt Centrum, Unknown 600 02, Sweden

Vardcentralen, Unknown 660 60, Sweden

Kronobergskliniken, Vaexjoe SE-352 34, Sweden

Centrallasarettet, Vasteras 721 89, Sweden

Vasterviks Sjukhus, Vastervik 593 81, Sweden

Novakliniken, Ystad 271 39, Sweden

Cukurova University Medical Faculty, Adana 01330, Turkey

Karadeniz Technical University Medical Faculty, Trabzon 61080, Turkey

Consorci Hospitalari Del Parc Tauli, Sabadell, Barcelona 08208, Spain

Hospital Universitario de Puerto Real, Puerto Real, Cadiz 11510, Spain

Hopital de Rangueil, Toulouse, Cedex 04 31403, France

Neurology Clinic of Chania, Souda, Chania,crete 73100, Greece

Universita Degli Studi Di Modena-Policlinico Dipartimento Di Medicina Interna, Modena, Emilia-romagna 41100, Italy

Fondazione Istituto Neurologico Casimiro Mondino Istituto Di Ricovero E Cura A Carattere Scientifico, Pavia, Lombardia 27100, Italy

Fundacion Hospital Alcorcon, Alcorcon, Madrid 28922, Spain

Veyrie-Courtade, Toulouse, Tououse 31500, France

C.H.U.R Bretonneau, Tours Cedex, Tours 37044, France

Hospital de Galdakao, Galdakao, Vizcaya 48960, Spain

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: March 2000
Last updated: May 17, 2013

Page last updated: August 23, 2015

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