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

January 26, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
971

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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
        • Hôpital 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
        • Hopital 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2000

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2002

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2002

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 13, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 22, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 27, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A1601015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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