Eletriptan Provides Consistent Migraine Relief: Results Of A Within-Patient Multiple-Dose Study
A Multicentre, Dose Optimisation Study to Assess the Consistency of Efficacy of Eletriptan for the Treatment of Migraine (With and Without Aura)
1 other identifier
interventional
971
14 countries
140
Brief Summary
Evaluation of headache response at 2 hours for active treated attacks for increasing dose.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2000
140 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2002
CompletedFirst Submitted
Initial submission to the registry
May 13, 2013
CompletedFirst Posted
Study publicly available on registry
May 22, 2013
CompletedJanuary 27, 2021
January 1, 2021
2 years
May 13, 2013
January 26, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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.
24 weeks
Secondary Outcomes (1)
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.
24 weeks
Study Arms (3)
Placebo
PLACEBO COMPARATOREletriptan HBr 40 mg
EXPERIMENTALEletriptan HBr 80 mg
EXPERIMENTALInterventions
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.
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.
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
You may qualify if:
- 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
You may not qualify if:
- Known coronary-artery disease, clinically significant arrhythmia, heart failure, or uncontrolled hypertension.
- Pregnant or lactating women.
- Clinically significant electrocardiogram abnormalities at screening.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (148)
Eeuwfeestkliniek
Antwerp, 2018, Belgium
A.Z. Sint Jan
Bruges, 8000, Belgium
Cliniques Universitaires St Luc
Brussels, 1200, Belgium
C.H.U. de Charleroi
Charleroi, 6000, Belgium
Hopital de La Citadelle
Liège, 4000, Belgium
Faculty Hospital U Svety Anny
Brno, 65691, Czechia
Neurologika Klinika F.N.
Hradec Králové, 50005, Czechia
Pain Centrum
Prague, 12 850, Czechia
1St Medical Faculty of the Charles University
Prague, 12000, Czechia
Arhus Kommunehospital
Arhus C, 8000, Denmark
Kas Glostrup
Glostrup Municipality, 2600, Denmark
Korsgaard, Anne G. (Private Practice)
Odense C, 5000, Denmark
Asbjorn Ziebel
Roskilde, 4000, Denmark
Peter Staehr
Ølstykke, 3650, Denmark
Hopital de Rangueil
Toulouse, Cedex 04, 31403, France
Veyrie-Courtade
Toulouse, Tououse, 31500, France
C.H.U.R Bretonneau
Tours, Tours, 37044, France
Kubler Altkirch
Altkirch, 68130, France
Marcombes Angouleme
Angoulême, 16000, France
Houdart Anzin
Anzin, 59416, France
Groupe Pellegrin Tripode
Bordeaux, 33076, France
Siboni Carcassonne
Carcassonne, 11000, France
Hopital Louis Mourier
Colombes, 92701, France
Cormier Laval
Laval, 53000, France
Hopital Salengro
Lille, 59037, France
Hopital Louis Pradel
Lyon, 69394, France
Hopital Pasteur
Nice, 06200, France
Private Practice
Orléans, 45000, France
Delfiner Paris
Paris, 75015, France
Hopital Lariboisiere
Paris, 75475, France
Hopital Cochin
Paris Codex 14, 75679, France
Vaunaize Reims (Ds For Oc)
Reims, 51100, France
Vaunaize Reims
Reims, 51100, France
Hopital Charles Nicolle
Rouen, 76031, France
Hospital Bellevue
Saint-Etienne, 42055, France
Bouchacourt Toulon
Toulon, 83 000, France
Lemarquis Toulon
Toulon, 83000, France
Mick Voiron
Voiron, 38500, France
Private Practice
Berlin, 10117, Germany
Private Practice
Berlin, 12687, Germany
Private Practice (Guenther Schumann)
Bochum, 44805, Germany
Private Practice
Bochum, 44807, Germany
Private Practice
Eckernförde, 24340, Germany
Private Practice
Göttingen, 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
Neurology Clinic of Chania
Soúda, Chania,crete, 73100, Greece
General Athens State Hospital
Athens, GR 156 69, Greece
Saint Dimitrios Hospital
Thessaloniki, GR 546 34, Greece
Peterfy Teaching Hospital
Budapest, 1076, Hungary
Semmelweis University
Budapest, 1083, Hungary
Szent-Imre Hospital
Budapest, 1115, Hungary
Jahn Ferenc Hospital
Budapest, 1201, Hungary
Uzsoki Hospital
Budapest, 1426, Hungary
University of Debrecen, Medical and Health Science Centre, Medical School
Debrecen, 4012, Hungary
Kenezy County Hospital
Debrecen, 4034, Hungary
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, Lombardy, 27100, Italy
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"
Milan, 20133, Italy
Universita Di Padova
Padua, 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 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
Tønsberg, 3111, Norway
Hospital Garcia Da Orta
Almada, 2800, Portugal
Centro Hospitalar de Coimbra
Coimbra, 3000, Portugal
Hospital S.Joao
Porto, 4000, Portugal
Consorci Hospitalari Del Parc Tauli
Sabadell, Barcelona, 08208, Spain
Hospital Universitario de Puerto Real
Puerto Real, Cadiz, 11510, Spain
Fundacion Hospital Alcorcon
Alcorcón, Madrid, 28922, Spain
Hospital de Galdakao
Galdakao, Vizcaya, 48960, Spain
Hospital Torrecardenas
Almería, 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 Na Sa de Aranzazu
Donostia / San Sebastian, 20014, Spain
Hospital Ciudad de Jaen
Jaén, 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
Málaga, 29010, Spain
Hospital General Universitario J. M. Morales Meseguer
Murcia, 30008, Spain
Hospital General de Asturias
Oviedo, 33006, Spain
Hospital Nuestra SE�Ra de Valme
Seville, 41014, Spain
Hospital Clinico Universitario La Fe
Valencia, 46009, Spain
Hospital General Universitario
Valencia, 46014, Spain
Fritsla Vardcentral
Fritsla, 510 29, Sweden
Migranklinik-Goeteborg
Gothenburg, SE-411 17, Sweden
Lanssjukhuset Halmstad
Halmstad, 301 85, Sweden
Viktoriakliniken
Halmstad, 30246, Sweden
Neurologsektionen, Lasarettet
Helsingborg, 251 87, Sweden
Neuro Kliniken, Helsingborg
Helsingborg, 25221, Sweden
Sjocrona Vardcentral
Höganäs, 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
Märsta, 195 30, Sweden
Oxelohalsan
Oxelösund, 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 (Ds For Oc)
Tyreso, 135 21, Sweden
Tyresohalsan Huslakare Ab
Tyreso, 135 21, Sweden
Kronobergskliniken
Vaxjo, SE-352 34, Sweden
Centrallasarettet
Västerås, 721 89, Sweden
Vasterviks Sjukhus
Västervik, 593 81, Sweden
Novakliniken
Ystad, 271 39, Sweden
Cukurova University Medical Faculty
Adana, 01330, Turkey (Türkiye)
Karadeniz Technical University Medical Faculty
Trabzon, 61080, Turkey (Türkiye)
Ahepa University Hospital
Foretagshalsovarden Linden
Huslakargruppen
Limhamns Lakargrupp, Tarnan
Medicinskt Centrum
Sentralsjukehuset I Hedmark
Sint Anna Ziekenhuis
Vardcentralen
Related Publications (1)
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.
PMID: 23946318DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2013
First Posted
May 22, 2013
Study Start
March 1, 2000
Primary Completion
March 1, 2002
Study Completion
March 1, 2002
Last Updated
January 27, 2021
Record last verified: 2021-01