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)

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

Study Overview

• Status: Completed
• Conditions: Migraine Without Aura; Migraine With Aura
• Intervention / Treatment: Drug: Placebo; Drug: Eletriptan HBr 40 mg; Drug: Eletriptan HBr 80 mg

• Study Type: Interventional
• Enrollment (Actual): 971
• Phase: Phase 3

Contacts and Locations

Study Locations

• • • Ahepa University Hospital
  • • Foretagshalsovarden Linden
  • • Huslakargruppen
  • • Limhamns Lakargrupp, Tarnan
  • • Medicinskt Centrum
  • • Sentralsjukehuset I Hedmark
  • • Sint Anna Ziekenhuis
  • • Vardcentralen
• Belgium
  • Antwerpen, Belgium, 2018
    • Eeuwfeestkliniek
  • Brugge, Belgium, 8000
    • A.Z. Sint Jan
  • Bruxelles, Belgium, 1200
    • Cliniques Universitaires St Luc
  • Charleroi, Belgium, 6000
    • C.H.U. de Charleroi
  • Liege, Belgium, 4000
    • Hôpital de la Citadelle
• Czechia
  • Brno, Czechia, 65691
    • Faculty Hospital U Svety Anny
  • Hradec Kralove, Czechia, 50005
    • Neurologika Klinika F.N.
  • Prague 2, Czechia, 12 850
    • Pain Centrum
  • Prague 2, Czechia, 12000
    • 1St Medical Faculty of the Charles University
• Denmark
  • Arhus C, Denmark, 8000
    • Århus Kommunehospital
  • Glostrup, Denmark, 2600
    • KAS Glostrup
  • Odense C, Denmark, 5000
    • Korsgaard, Anne G. (Private Practice)
  • Olstykke, Denmark, 3650
    • Peter Staehr
  • Roskilde, Denmark, 4000
    • Asbjorn Ziebel
• France
  • Altkirch, France, 68130
    • Kubler Altkirch
  • Angouleme, France, 16000
    • Marcombes Angouleme
  • Anzin, France, 59416
    • Houdart Anzin
  • Bordeaux Cedex, France, 33076
    • Groupe Pellegrin Tripode
  • Carcassonne, France, 11000
    • Siboni Carcassonne
  • Colombes Cedex, France, 92701
    • Hopital Louis Mourier
  • Laval, France, 53000
    • Cormier Laval
  • Lille, France, 59037
    • Hôpital Salengro
  • Lyon Cedex 03, France, 69394
    • Hopital Louis Pradel
  • Nice Cedex 1, France, 06200
    • Hôpital Pasteur
  • Orleans, France, 45000
    • Private Practice
  • Paris, France, 75475
    • Hôpital Lariboisière
  • Paris, France, 75015
    • Delfiner Paris
  • Paris Codex 14, France, 75679
    • Hôpital Cochin
  • Reims, France, 51100
    • Vaunaize Reims (Ds For Oc)
  • Reims, France, 51100
    • Vaunaize Reims
  • Rouen, France, 76031
    • Hôpital Charles Nicolle
  • Saint Etienne Cedex 2, France, 42055
    • Hospital Bellevue
  • Toulon, France, 83 000
    • Bouchacourt Toulon
  • Toulon, France, 83000
    • Lemarquis Toulon
  • Voiron, France, 38500
    • Mick Voiron
  • Cedex 04
    • Toulouse, Cedex 04, France, 31403
      • Hôpital de Rangueil
  • Tououse
    • Toulouse, Tououse, France, 31500
      • Veyrie-Courtade
  • Tours
    • Tours Cedex, Tours, France, 37044
      • C.H.U.R Bretonneau
• Germany
  • Berlin, Germany, 10117
    • Private Practice
  • Berlin, Germany, 12687
    • Private Practice
  • Bochum, Germany, 44805
    • Private Practice (Guenther Schumann)
  • Bochum, Germany, 44807
    • Private Practice
  • Eckernfoerde, Germany, 24340
    • Private Practice
  • Goettingen, Germany, 37073
    • Private Practice
  • Hamburg, Germany, 22149
    • Private Practice
  • Oldenburg, Germany, 26131
    • Private Practice
  • Schwendi, Germany, 88475
    • Fachklinik Fuer Neurologie Dietenbronn Gmbh
  • Stade, Germany, 21680
    • Private Practice (Dr. Renate Kreyer)
• Greece
  • Athens, Greece, GR 156 69
    • General Athens State Hospital
  • Thessaloniki, Greece, GR 546 34
    • Saint Dimitrios Hospital
  • Chania,crete
    • Souda, Chania,crete, Greece, 73100
      • Neurology Clinic of Chania
• Hungary
  • Budapest, Hungary, 1083
    • Semmelweis University
  • Budapest, Hungary, 1076
    • Peterfy Teaching Hospital
  • Budapest, Hungary, 1115
    • Szent-Imre Hospital
  • Budapest, Hungary, 1201
    • Jahn Ferenc Hospital
  • Budapest, Hungary, 1426
    • Uzsoki Hospital
  • Debrecen, Hungary, 4012
    • University of Debrecen, Medical and Health Science Centre, Medical School
  • Debrecen, Hungary, 4034
    • Kenezy County Hospital
• Italy
  • Bologna, Italy, 40123
    • Universita' Di Bologna
  • Brescia, Italy, 25100
    • Poliambulatorio Salus
  • Cagliari, Italy, 09124
    • Universita' Degli Studi Di Cagliari - Presidio Osp.S.Giovanni Di Dio
  • Catania, Italy, 95100
    • Azienda Vittorio Emanuele
  • L'aquila-coppito, Italy, 67100
    • Clinica Neurologica
  • Messina, Italy, 98125
    • Policlinico Universitario
  • Milano, Italy, 20133
    • Centro Cefalee Irccs "C. Besta"
  • Padova, Italy, 35128
    • Universita Di Padova
  • Parma, Italy, 43100
    • Centro Cefalee
  • Perugia, Italy, 06126
    • Clinica Neurologica, Universita Di Perugia
  • Pozzilli (isernia), Italy, 86077
    • Centro Cefalee - Neuromed
  • Roma, Italy, 00100
    • Ospedale S. Eugenio
  • Torino, Italy, 10126
    • Centro Cefalee
  • Torrette DI Ancona (AN), Italy, 60020
    • Ospedale Regionale Torrette
  • Trieste, Italy, 34126
    • Ospedale Maggiore
  • Vicenza, Italy, 36100
    • Ospedale S. Bortolo
  • Emilia-romagna
    • Modena, Emilia-romagna, Italy, 41100
      • Universita Degli Studi Di Modena-Policlinico Dipartimento Di Medicina Interna
  • Lombardia
    • Pavia, Lombardia, Italy, 27100
      • Fondazione Istituto Neurologico Casimiro Mondino Istituto Di Ricovero E Cura A Carattere Scientifico
• Netherlands
  • 's-hertogenbosch, Netherlands, 5223GV
    • Bosch Medicentrum (Locatie Willem Alexander Ziekenhuis)
  • Amsterdam, Netherlands, 1061 AE
    • Sint Lucas Andreas Ziekenhuis (Location: St.Lucas)
  • Apeldoorn, Netherlands, 7334 DZ
    • Gelre Ziekenhuis (Location: Lukas)
  • Blaricum, Netherlands, 1261 AN
    • Ziekenhuis Gooi-Noord
  • Breda, Netherlands, 4818 CK
    • Ignatius Ziekenhuis Breda
  • EDE, Netherlands, 6711 PV
    • Gelderse Vallei Ziekenhuis
  • Emmen, Netherlands, 7824 AA
    • Scheperziekenhuis
  • Heerlen, Netherlands, 6419 PC
    • Atrium Heerlen
  • Hengelo (OV), Netherlands, 7555DL
    • St. Streekziekenhuis Midden Twente
  • Rotterdam, Netherlands, 3083 AN
    • Ikazia Ziekenhuis
  • Venray, Netherlands, 5801 CE
    • Sint Elisabeth Ziekenhuis
  • Zoetermeer, Netherlands, 2725 NA
    • Lage Land Ziekenhuis
• Norway
  • Nordbyhagen, Norway, 1474
    • Sentralsykehuset I Akershus
  • Oslo, Norway, 0303
    • Volvat Medisinske Senter
  • Tonsberg, Norway, 3111
    • Strandquist, Dr. Stein Bror
• Portugal
  • Almada, Portugal, 2800
    • Hospital Garcia da Orta
  • Coimbra, Portugal, 3000
    • Centro Hospitalar de Coimbra
  • Porto, Portugal, 4000
    • Hospital S.JOÃO
• Spain
  • Almeria, Spain, 04009
    • Hospital Torrecardenas
  • Barcelona, Spain, 08029
    • Hospital Del Sagrado Corazon
  • Barcelona, Spain, 08035
    • Hospital General Universitari Vall D�Hebron
  • Burgos, Spain, 09005
    • Hospital General Yag�
  • Ciudad Real, Spain, 13002
    • Hospital Nuestra SE�Ra de Alarcos
  • Jaen, Spain, 23007
    • Hospital Ciudad de Jaén
  • Lleida, Spain, 25198
    • Hospital Universitari de Lleida Arnau de Vilanova
  • Madrid, Spain, 28034
    • Hospital Ramon y Cajal
  • Madrid, Spain, 28040
    • Hospital Universitario San Carlos
  • Malaga, Spain, 29010
    • Hospital Virgen de la Victoria
  • Murcia, Spain, 30008
    • Hospital General Universitario J. M. Morales Meseguer
  • Oviedo, Spain, 33006
    • Hospital General De Asturias
  • San Sebastian, Spain, 20014
    • Hospital Na Sa de Aranzazu
  • Sevilla, Spain, 41014
    • Hospital Nuestra SE�Ra de Valme
  • Valencia, Spain, 46014
    • Hospital General Universitario
  • Valencia, Spain, 46009
    • Hospital Clinico Universitario La Fe
  • Barcelona
    • Sabadell, Barcelona, Spain, 08208
      • Consorci Hospitalari del Parc Tauli
  • Cadiz
    • Puerto Real, Cadiz, Spain, 11510
      • Hospital Universitario de Puerto Real
  • Madrid
    • Alcorcon, Madrid, Spain, 28922
      • Fundacion Hospital Alcorcon
  • Vizcaya
    • Galdakao, Vizcaya, Spain, 48960
      • Hospital de Galdakao
• Sweden
  • Fritsla, Sweden, 510 29
    • Fritsla Vardcentral
  • Goeteborg, Sweden, SE-411 17
    • Migranklinik-Goeteborg
  • Halmstad, Sweden, 301 85
    • Lanssjukhuset Halmstad
  • Halmstad, Sweden, 30246
    • Viktoriakliniken
  • Helsingborg, Sweden, 251 87
    • Neurologsektionen, Lasarettet
  • Helsingborg, Sweden, 25221
    • Neuro Kliniken, Helsingborg
  • Hoganas, Sweden, 263 26
    • Sjocrona Vardcentral
  • Huddinge, Sweden
    • Huddinge Universitetssjukhus
  • Kista, Sweden, 164 40
    • Kistahalsan Ab
  • Lund, Sweden, 221 21
    • Lund Lakarmottagningen
  • Lund, Sweden, 22185
    • Medicin Kliniken, Universitetssjukhuset
  • Malmo, Sweden, 211 36
    • Lakargruppen Gustaf Adolf
  • Marsta, Sweden, 195 30
    • Previa Ab Sigtunahalsan
  • Oxelosund, Sweden, 613 30
    • Oxelohalsan
  • Stockholm, Sweden, 105 34
    • Bankhalsan
  • Stockholm, Sweden, 113 22
    • Läkarhuset Odenplan
  • Stockholm, Sweden, 11486
    • Ostermalmshalsan
  • Stockholm, Sweden, SE-112 81
    • St Gorans Sjukhus
  • Tyreso, Sweden, 135 21
    • Tyresohalsan Huslakare Ab (Ds For Oc)
  • Tyreso, Sweden, 135 21
    • Tyresohalsan Huslakare Ab
  • Vaexjoe, Sweden, SE-352 34
    • Kronobergskliniken
  • Vasteras, Sweden, 721 89
    • Centrallasarettet
  • Vastervik, Sweden, 593 81
    • Västerviks sjukhus
  • Ystad, Sweden, 271 39
    • Novakliniken
• Turkey
  • Adana, Turkey, 01330
    • Cukurova University Medical Faculty
  • Trabzon, Turkey, 61080
    • Karadeniz Technical University Medical Faculty

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	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.
Experimental: Eletriptan HBr 40 mg	Drug: 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.
Experimental: Eletriptan HBr 80 mg	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

General Publications

• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: March 1, 2000
• Primary Completion (Actual): March 1, 2002
• Study Completion (Actual): March 1, 2002

Study Registration Dates

• First Submitted: May 13, 2013
• First Submitted That Met QC Criteria: May 17, 2013
• First Posted (Estimate): May 22, 2013

Study Record Updates

• Last Update Posted (Actual): January 27, 2021
• Last Update Submitted That Met QC Criteria: January 26, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Epilepsy; Migraine Disorders; Migraine without Aura; Migraine with Aura; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Serotonin Agents; Serotonin Receptor Agonists; Eletriptan
• Other Study ID Numbers: A1601015