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NCT01859481 Clinical Trial

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

Migraine Without Aura Clinical Trial

Official title:
A Multicentre, Dose Optimisation Study to Assess the Consistency of Efficacy of Eletriptan for the Treatment of Migraine (With and Without Aura)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01859481
Other study ID # A1601015
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date March 2000
Est. completion date March 2002

Study information
Verified date January 2021
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 971
Est. completion date March 2002
Est. primary completion date March 2002
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• 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.

Locations
Country Name City State
Ahepa University Hospital
Foretagshalsovarden Linden
Huslakargruppen
Limhamns Lakargrupp, Tarnan
Medicinskt Centrum
Sentralsjukehuset I Hedmark
Sint Anna Ziekenhuis
Vardcentralen
Belgium Eeuwfeestkliniek Antwerpen
Belgium A.Z. Sint Jan Brugge
Belgium Cliniques Universitaires St Luc Bruxelles
Belgium C.H.U. de Charleroi Charleroi
Belgium Hopital de La Citadelle Liege
Czechia Faculty Hospital U Svety Anny Brno
Czechia Neurologika Klinika F.N. Hradec Kralove
Czechia 1St Medical Faculty of the Charles University Prague 2
Czechia Pain Centrum Prague 2
Denmark Arhus Kommunehospital Arhus C
Denmark Kas Glostrup Glostrup
Denmark Korsgaard, Anne G. (Private Practice) Odense C
Denmark Peter Staehr Olstykke
Denmark Asbjorn Ziebel Roskilde
France Kubler Altkirch Altkirch
France Marcombes Angouleme Angouleme
France Houdart Anzin Anzin
France Groupe Pellegrin Tripode Bordeaux Cedex
France Siboni Carcassonne Carcassonne
France Hopital Louis Mourier Colombes Cedex
France Cormier Laval Laval
France Hopital Salengro Lille
France Hopital Louis Pradel Lyon Cedex 03
France Hopital Pasteur Nice Cedex 1
France Private Practice Orleans
France Delfiner Paris Paris
France Hopital Lariboisiere Paris
France Hopital Cochin Paris Codex 14
France Vaunaize Reims Reims
France Vaunaize Reims (Ds For Oc) Reims
France Hopital Charles Nicolle Rouen
France Hospital Bellevue Saint Etienne Cedex 2
France Bouchacourt Toulon Toulon
France Lemarquis Toulon Toulon
France Hopital de Rangueil Toulouse Cedex 04
France Veyrie-Courtade Toulouse Tououse
France C.H.U.R Bretonneau Tours Cedex Tours
France Mick Voiron Voiron
Germany Private Practice Berlin
Germany Private Practice Berlin
Germany Private Practice Bochum
Germany Private Practice (Guenther Schumann) Bochum
Germany Private Practice Eckernfoerde
Germany Private Practice Goettingen
Germany Private Practice Hamburg
Germany Private Practice Oldenburg
Germany Fachklinik Fuer Neurologie Dietenbronn Gmbh Schwendi
Germany Private Practice (Dr. Renate Kreyer) Stade
Greece General Athens State Hospital Athens
Greece Neurology Clinic of Chania Souda Chania,crete
Greece Saint Dimitrios Hospital Thessaloniki
Hungary Jahn Ferenc Hospital Budapest
Hungary Peterfy Teaching Hospital Budapest
Hungary Semmelweis University Budapest
Hungary Szent-Imre Hospital Budapest
Hungary Uzsoki Hospital Budapest
Hungary Kenezy County Hospital Debrecen
Hungary University of Debrecen, Medical and Health Science Centre, Medical School Debrecen
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" Milano
Italy Universita Degli Studi Di Modena-Policlinico Dipartimento Di Medicina Interna Modena Emilia-romagna
Italy Universita Di Padova Padova
Italy Centro Cefalee Parma
Italy Fondazione Istituto Neurologico Casimiro Mondino Istituto Di Ricovero E Cura A Carattere Scientifico Pavia Lombardia
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
Netherlands 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
Norway Sentralsykehuset I Akershus Nordbyhagen
Norway Volvat Medisinske Senter Oslo
Norway Strandquist, Dr. Stein Bror Tonsberg
Portugal Hospital Garcia Da Orta Almada
Portugal Centro Hospitalar de Coimbra Coimbra
Portugal Hospital S.Joao Porto
Spain Fundacion Hospital Alcorcon Alcorcon Madrid
Spain Hospital Torrecardenas Almeria
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 de Galdakao Galdakao Vizcaya
Spain Hospital Ciudad de Jaen Jaen
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 Malaga
Spain Hospital General Universitario J. M. Morales Meseguer Murcia
Spain Hospital General de Asturias Oviedo
Spain Hospital Universitario de Puerto Real Puerto Real Cadiz
Spain Consorci Hospitalari Del Parc Tauli Sabadell Barcelona
Spain Hospital Na Sa de Aranzazu San Sebastian
Spain Hospital Nuestra SE?Ra de Valme Sevilla
Spain Hospital Clinico Universitario La Fe Valencia
Spain Hospital General Universitario Valencia
Sweden Fritsla Vardcentral Fritsla
Sweden Migranklinik-Goeteborg Goeteborg
Sweden Lanssjukhuset Halmstad Halmstad
Sweden Viktoriakliniken Halmstad
Sweden Neuro Kliniken, Helsingborg Helsingborg
Sweden Neurologsektionen, Lasarettet Helsingborg
Sweden Sjocrona Vardcentral Hoganas
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 Marsta
Sweden Oxelohalsan Oxelosund
Sweden Bankhalsan Stockholm
Sweden Lakarhuset Odenplan Stockholm
Sweden Ostermalmshalsan Stockholm
Sweden St Gorans Sjukhus Stockholm
Sweden Tyresohalsan Huslakare Ab Tyreso
Sweden Tyresohalsan Huslakare Ab (Ds For Oc) Tyreso
Sweden Kronobergskliniken Vaexjoe
Sweden Centrallasarettet Vasteras
Sweden Vasterviks Sjukhus Vastervik
Sweden Novakliniken Ystad
Turkey Cukurova University Medical Faculty Adana
Turkey Karadeniz Technical University Medical Faculty Trabzon

Sponsors (1)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Countries where clinical trial is conducted

Belgium,  Czechia,  Denmark,  France,  Germany,  Greece,  Hungary,  Italy,  Netherlands,  Norway,  Portugal,  Spain,  Sweden,  Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
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