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Migraine Without AuraPhase 3NCT01859481

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

A Phase 3 study testing Eletriptan HBr 40 mg and Eletriptan HBr 80 mg in people with Migraine Without Aura and Migraine With Aura, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 148 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Evaluation of headache response at 2 hours for active treated attacks for increasing dose. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Migraine Without Aura, Migraine With Aura
What is being tested?
Eletriptan HBr 40 mg and Eletriptan HBr 80 mg
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
971 participants
Where
148 sitesin 15 countries
Study dates
Mar 2000to Mar 2002
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Known coronary-artery disease, clinically significant arrhythmia, heart failure, or uncontrolled hypertension.
  • Pregnant or lactating women.
  • Clinically significant electrocardiogram abnormalities at screening.

Trial locations and contacts

148 sites in 15 countries.

148 sites in 15 countries

France24 sites

  • Kubler Altkirch

    Altkirch, 68130

  • Marcombes Angouleme

    Angoulême, 16000

  • Houdart Anzin

    Anzin, 59416

  • Groupe Pellegrin Tripode

    Bordeaux, 33076

  • Siboni Carcassonne

    Carcassonne, 11000

  • Hopital Louis Mourier

    Colombes, 92701

  • Cormier Laval

    Laval, 53000

  • Hopital Salengro

    Lille, 59037

  • Hopital Louis Pradel

    Lyon, 69394

  • Hopital Pasteur

    Nice, 06200

  • Private Practice

    Orléans, 45000

  • Delfiner Paris

    Paris, 75015

  • Hopital Lariboisiere

    Paris, 75475

  • Hopital Cochin

    Paris Codex 14, 75679

  • Vaunaize Reims (Ds For Oc)

    Reims, 51100

  • Vaunaize Reims

    Reims, 51100

  • Hopital Charles Nicolle

    Rouen, 76031

  • Hospital Bellevue

    Saint-Etienne, 42055

  • Bouchacourt Toulon

    Toulon, 83 000

  • Lemarquis Toulon

    Toulon, 83000

  • Hopital de Rangueil

    Toulouse, Cedex 04, 31403

  • Veyrie-Courtade

    Toulouse, Tououse, 31500

  • C.H.U.R Bretonneau

    Tours, Tours, 37044

  • Mick Voiron

    Voiron, 38500

Other trials in France

Sweden24 sites

  • Fritsla Vardcentral

    Fritsla, 510 29

  • Migranklinik-Goeteborg

    Gothenburg, SE-411 17

  • Lanssjukhuset Halmstad

    Halmstad, 301 85

  • Viktoriakliniken

    Halmstad, 30246

  • Neurologsektionen, Lasarettet

    Helsingborg, 251 87

  • Neuro Kliniken, Helsingborg

    Helsingborg, 25221

  • Sjocrona Vardcentral

    Höganäs, 263 26

  • Huddinge Universitetssjukhus

    Huddinge

  • Kistahalsan Ab

    Kista, 164 40

  • Lund Lakarmottagningen

    Lund, 221 21

  • Medicin Kliniken, Universitetssjukhuset

    Lund, 22185

  • Lakargruppen Gustaf Adolf

    Malmö, 211 36

  • Previa Ab Sigtunahalsan

    Märsta, 195 30

  • Oxelohalsan

    Oxelösund, 613 30

  • Bankhalsan

    Stockholm, 105 34

  • Lakarhuset Odenplan

    Stockholm, 113 22

  • Ostermalmshalsan

    Stockholm, 11486

  • St Gorans Sjukhus

    Stockholm, SE-112 81

  • Tyresohalsan Huslakare Ab (Ds For Oc)

    Tyreso, 135 21

  • Tyresohalsan Huslakare Ab

    Tyreso, 135 21

  • Centrallasarettet

    Västerås, 721 89

  • Vasterviks Sjukhus

    Västervik, 593 81

  • Kronobergskliniken

    Vaxjo, SE-352 34

  • Novakliniken

    Ystad, 271 39

Other trials in Sweden

Spain20 sites

  • Fundacion Hospital Alcorcon

    Alcorcón, Madrid, 28922

  • Hospital Torrecardenas

    Almería, 04009

  • Hospital Del Sagrado Corazon

    Barcelona, 08029

  • Hospital General Universitari Vall D�Hebron

    Barcelona, 08035

  • Hospital General Yag�

    Burgos, 09005

  • Hospital Nuestra SE�Ra de Alarcos

    Ciudad Real, 13002

  • Hospital Na Sa de Aranzazu

    Donostia / San Sebastian, 20014

  • Hospital de Galdakao

    Galdakao, Vizcaya, 48960

  • Hospital Ciudad de Jaen

    Jaén, 23007

  • Hospital Universitari de Lleida Arnau de Vilanova

    Lleida, 25198

  • Hospital Ramon Y Cajal

    Madrid, 28034

  • Hospital Universitario San Carlos

    Madrid, 28040

  • Hospital Virgen de La Victoria

    Málaga, 29010

  • Hospital General Universitario J. M. Morales Meseguer

    Murcia, 30008

  • Hospital General de Asturias

    Oviedo, 33006

  • Hospital Universitario de Puerto Real

    Puerto Real, Cadiz, 11510

  • Consorci Hospitalari Del Parc Tauli

    Sabadell, Barcelona, 08208

  • Hospital Nuestra SE�Ra de Valme

    Seville, 41014

  • Hospital Clinico Universitario La Fe

    Valencia, 46009

  • Hospital General Universitario

    Valencia, 46014

Other trials in Spain

Italy18 sites

  • Universita' Di Bologna

    Bologna, 40123

  • Poliambulatorio Salus

    Brescia, 25100

  • Universita' Degli Studi Di Cagliari - Presidio Osp.S.Giovanni Di Dio

    Cagliari, 09124

  • Azienda Vittorio Emanuele

    Catania, 95100

  • Clinica Neurologica

    L'aquila-coppito, 67100

  • Policlinico Universitario

    Messina, 98125

  • Centro Cefalee Irccs "C. Besta"

    Milan, 20133

  • Universita Degli Studi Di Modena-Policlinico Dipartimento Di Medicina Interna

    Modena, Emilia-Romagna, 41100

  • Universita Di Padova

    Padova, 35128

  • Centro Cefalee

    Parma, 43100

  • Fondazione Istituto Neurologico Casimiro Mondino Istituto Di Ricovero E Cura A Carattere Scientifico

    Pavia, Lombardy, 27100

  • Clinica Neurologica, Universita Di Perugia

    Perugia, 06126

  • Centro Cefalee - Neuromed

    Pozzilli (isernia), 86077

  • Ospedale S. Eugenio

    Roma, 00100

  • Centro Cefalee

    Torino, 10126

  • Ospedale Regionale Torrette

    Torrette DI Ancona (AN), 60020

  • Ospedale Maggiore

    Trieste, 34126

  • Ospedale S. Bortolo

    Vicenza, 36100

Other trials in Italy

Netherlands12 sites

  • Bosch Medicentrum (Locatie Willem Alexander Ziekenhuis)

    's-Hertogenbosch, 5223GV

  • Sint Lucas Andreas Ziekenhuis (Location: St.Lucas)

    Amsterdam, 1061 AE

  • Gelre Ziekenhuis (Location: Lukas)

    Apeldoorn, 7334 DZ

  • Ziekenhuis Gooi-Noord

    Blaricum, 1261 AN

  • Ignatius Ziekenhuis Breda

    Breda, 4818 CK

  • Gelderse Vallei Ziekenhuis

    Ede, 6711 PV

  • Scheperziekenhuis

    Emmen, 7824 AA

  • Atrium Heerlen

    Heerlen, 6419 PC

  • St. Streekziekenhuis Midden Twente

    Hengelo (OV), 7555DL

  • Ikazia Ziekenhuis

    Rotterdam, 3083 AN

  • Sint Elisabeth Ziekenhuis

    Venray, 5801 CE

  • Lage Land Ziekenhuis

    Zoetermeer, 2725 NA

Other trials in Netherlands

Germany10 sites

  • Private Practice

    Berlin, 10117

  • Private Practice

    Berlin, 12687

  • Private Practice (Guenther Schumann)

    Bochum, 44805

  • Private Practice

    Bochum, 44807

  • Private Practice

    Eckernförde, 24340

  • Private Practice

    Göttingen, 37073

  • Private Practice

    Hamburg, 22149

  • Private Practice

    Oldenburg, 26131

  • Fachklinik Fuer Neurologie Dietenbronn Gmbh

    Schwendi, 88475

  • Private Practice (Dr. Renate Kreyer)

    Stade, 21680

Other trials in Germany

Location not given8 sites

  • Ahepa University Hospital

  • Foretagshalsovarden Linden

  • Huslakargruppen

  • Limhamns Lakargrupp, Tarnan

  • Medicinskt Centrum

  • Sentralsjukehuset I Hedmark

  • Sint Anna Ziekenhuis

  • Vardcentralen

Hungary7 sites

  • Peterfy Teaching Hospital

    Budapest, 1076

  • Semmelweis University

    Budapest, 1083

  • Szent-Imre Hospital

    Budapest, 1115

  • Jahn Ferenc Hospital

    Budapest, 1201

  • Uzsoki Hospital

    Budapest, 1426

  • University of Debrecen, Medical and Health Science Centre, Medical School

    Debrecen, 4012

  • Kenezy County Hospital

    Debrecen, 4034

Other trials in Hungary

Belgium5 sites

  • Eeuwfeestkliniek

    Antwerp, 2018

  • A.Z. Sint Jan

    Bruges, 8000

  • Cliniques Universitaires St Luc

    Brussels, 1200

  • C.H.U. de Charleroi

    Charleroi, 6000

  • Hopital de La Citadelle

    Liège, 4000

Other trials in Belgium

Denmark5 sites

  • Arhus Kommunehospital

    Arhus C, 8000

  • Kas Glostrup

    Glostrup Municipality, 2600

  • Korsgaard, Anne G. (Private Practice)

    Odense C, 5000

  • Peter Staehr

    Ølstykke, 3650

  • Asbjorn Ziebel

    Roskilde, 4000

Other trials in Denmark

Czechia4 sites

  • Faculty Hospital U Svety Anny

    Brno, 65691

  • Neurologika Klinika F.N.

    Hradec Králové, 50005

  • Pain Centrum

    Prague, 12 850

  • 1St Medical Faculty of the Charles University

    Prague, 12000

Other trials in Czechia

Greece3 sites

  • General Athens State Hospital

    Athens, GR 156 69

  • Neurology Clinic of Chania

    Soúda, Chania,crete, 73100

  • Saint Dimitrios Hospital

    Thessaloniki, GR 546 34

Other trials in Greece

Norway3 sites

  • Sentralsykehuset I Akershus

    Nordbyhagen, 1474

  • Volvat Medisinske Senter

    Oslo, 0303

  • Strandquist, Dr. Stein Bror

    Tønsberg, 3111

Other trials in Norway

Portugal3 sites

  • Hospital Garcia Da Orta

    Almada, 2800

  • Centro Hospitalar de Coimbra

    Coimbra, 3000

  • Hospital S.Joao

    Porto, 4000

Other trials in Portugal

Turkey (Türkiye)2 sites

  • Cukurova University Medical Faculty

    Adana, 01330

  • Karadeniz Technical University Medical Faculty

    Trabzon, 61080

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Being tested
Placebo, Eletriptan HBr 40 mg, Eletriptan HBr 80 mg
Medical subject headings
Migraine without Aura, Migraine with Aura

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    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 mgDrug

    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 mgDrug

    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.

Study groups in NCT01859481
Study groupRoleWhat they receive
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo
Eletriptan HBr 40 mgExperimentalNot described
Receives: Drug: Eletriptan HBr 40 mg
Eletriptan HBr 80 mgExperimentalNot described
Receives: Drug: Eletriptan HBr 80 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 24 weeks

Secondary outcomes (1)

  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.

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2013 (estimated)
  2. Study startMar 2000
  3. Primary completionMar 2002
  4. Study completionMar 2002

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
971 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01859481
Sponsor's protocol ID
A1601015
Status last verified
Jan 2021
First submitted
13 May 2013
Last updated
27 Jan 2021
Results posted
No
Data monitoring committee
No

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.

    PubMed 23946318

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Eletriptan HBr 40 mg and Eletriptan HBr 80 mg in people with Migraine Without Aura and Migraine With Aura, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 148 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 148 sites in France, Sweden, Spain, Italy, Netherlands and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01859481, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2021.

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