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Evaluation of headache response at 2 hours for active treated attacks for increasing dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Eletriptan HBr 40 mg | Experimental |
| |
| Eletriptan HBr 80 mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | 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. |
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eeuwfeestkliniek | Antwerp | 2018 | Belgium | |||
| A.Z. Sint Jan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23946318 | Derived | 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. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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|
| Eletriptan HBr 40 mg | Drug | 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 | Drug | 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. |
|
| 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 | Padova | 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 | Malmö | 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 |
| ID | Term |
|---|---|
| D020326 | Migraine without Aura |
| D020325 | Migraine with Aura |
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C115647 | eletriptan |
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