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

PHASE3CompletedINTERVENTIONAL
Enrollment

971

Participants

Timeline

Start Date

March 31, 2000

Primary Completion Date

March 31, 2002

Study Completion Date

March 31, 2002

Conditions
Migraine Without AuraMigraine With Aura
Interventions
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.

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.

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.

Trial Locations (148)

1076

Peterfy Teaching Hospital, Budapest

1083

Semmelweis University, Budapest

1115

Szent-Imre Hospital, Budapest

1200

Cliniques Universitaires St Luc, Brussels

1201

Jahn Ferenc Hospital, Budapest

1426

Uzsoki Hospital, Budapest

1474

Sentralsykehuset I Akershus, Nordbyhagen

2018

Eeuwfeestkliniek, Antwerp

2600

Kas Glostrup, Glostrup Municipality

2800

Hospital Garcia Da Orta, Almada

3000

Centro Hospitalar de Coimbra, Coimbra

3111

Strandquist, Dr. Stein Bror, Tønsberg

3650

Peter Staehr, Ølstykke

4000

Hopital de La Citadelle, Liège

Asbjorn Ziebel, Roskilde

Hospital S.Joao, Porto

4012

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

4034

Kenezy County Hospital, Debrecen

5000

Korsgaard, Anne G. (Private Practice), Odense C

6000

C.H.U. de Charleroi, Charleroi

8000

A.Z. Sint Jan, Bruges

Arhus Kommunehospital, Arhus C

10117

Private Practice, Berlin

10126

Centro Cefalee, Torino

11000

Siboni Carcassonne, Carcassonne

11486

Ostermalmshalsan, Stockholm

11510

Hospital Universitario de Puerto Real, Puerto Real

12000

1St Medical Faculty of the Charles University, Prague

12687

Private Practice, Berlin

13002

Hospital Nuestra SE�Ra de Alarcos, Ciudad Real

16000

Marcombes Angouleme, Angoulême

20014

Hospital Na Sa de Aranzazu, Donostia / San Sebastian

20133

"Centro Cefalee Irccs C. Besta", Milan

21680

Private Practice (Dr. Renate Kreyer), Stade

22149

Private Practice, Hamburg

22185

Medicin Kliniken, Universitetssjukhuset, Lund

23007

Hospital Ciudad de Jaen, Jaén

24340

Private Practice, Eckernförde

25100

Poliambulatorio Salus, Brescia

25198

Hospital Universitari de Lleida Arnau de Vilanova, Lleida

25221

Neuro Kliniken, Helsingborg, Helsingborg

26131

Private Practice, Oldenburg

27100

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

28034

Hospital Ramon Y Cajal, Madrid

28040

Hospital Universitario San Carlos, Madrid

28922

Fundacion Hospital Alcorcon, Alcorcón

29010

Hospital Virgen de La Victoria, Málaga

30008

Hospital General Universitario J. M. Morales Meseguer, Murcia

30246

Viktoriakliniken, Halmstad

31403

Hopital de Rangueil, Toulouse

31500

Veyrie-Courtade, Toulouse

33006

Hospital General de Asturias, Oviedo

33076

Groupe Pellegrin Tripode, Bordeaux

34126

Ospedale Maggiore, Trieste

35128

Universita Di Padova, Padua

36100

Ospedale S. Bortolo, Vicenza

37044

C.H.U.R Bretonneau, Tours

37073

Private Practice, Göttingen

38500

Mick Voiron, Voiron

40123

Universita' Di Bologna, Bologna

41014

Hospital Nuestra SE�Ra de Valme, Seville

41100

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

42055

Hospital Bellevue, Saint-Etienne

43100

Centro Cefalee, Parma

44805

Private Practice (Guenther Schumann), Bochum

44807

Private Practice, Bochum

45000

Private Practice, Orléans

46009

Hospital Clinico Universitario La Fe, Valencia

46014

Hospital General Universitario, Valencia

48960

Hospital de Galdakao, Galdakao

50005

Neurologika Klinika F.N., Hradec Králové

51100

Vaunaize Reims (Ds For Oc), Reims

Vaunaize Reims, Reims

53000

Cormier Laval, Laval

59037

Hopital Salengro, Lille

59416

Houdart Anzin, Anzin

60020

Ospedale Regionale Torrette, Torrette DI Ancona (AN)

61080

Karadeniz Technical University Medical Faculty, Trabzon

65691

Faculty Hospital U Svety Anny, Brno

67100

Clinica Neurologica, L'aquila-coppito

68130

Kubler Altkirch, Altkirch

69394

Hopital Louis Pradel, Lyon

73100

Neurology Clinic of Chania, Soúda

75015

Delfiner Paris, Paris

75475

Hopital Lariboisiere, Paris

75679

Hopital Cochin, Paris Codex 14

76031

Hopital Charles Nicolle, Rouen

83000

Lemarquis Toulon, Toulon

86077

Centro Cefalee - Neuromed, Pozzilli (isernia)

88475

Fachklinik Fuer Neurologie Dietenbronn Gmbh, Schwendi

92701

Hopital Louis Mourier, Colombes

95100

Azienda Vittorio Emanuele, Catania

98125

Policlinico Universitario, Messina

12 850

Pain Centrum, Prague

06200

Hopital Pasteur, Nice

83 000

Bouchacourt Toulon, Toulon

GR 156 69

General Athens State Hospital, Athens

GR 546 34

Saint Dimitrios Hospital, Thessaloniki

09124

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

06126

Clinica Neurologica, Universita Di Perugia, Perugia

00100

Ospedale S. Eugenio, Roma

5223GV

Bosch Medicentrum (Locatie Willem Alexander Ziekenhuis), 's-Hertogenbosch

1061 AE

Sint Lucas Andreas Ziekenhuis (Location: St.Lucas), Amsterdam

7334 DZ

Gelre Ziekenhuis (Location: Lukas), Apeldoorn

1261 AN

Ziekenhuis Gooi-Noord, Blaricum

4818 CK

Ignatius Ziekenhuis Breda, Breda

6711 PV

Gelderse Vallei Ziekenhuis, Ede

7824 AA

Scheperziekenhuis, Emmen

6419 PC

Atrium Heerlen, Heerlen

7555DL

St. Streekziekenhuis Midden Twente, Hengelo (OV)

3083 AN

Ikazia Ziekenhuis, Rotterdam

5801 CE

Sint Elisabeth Ziekenhuis, Venray

2725 NA

Lage Land Ziekenhuis, Zoetermeer

0303

Volvat Medisinske Senter, Oslo

08208

Consorci Hospitalari Del Parc Tauli, Sabadell

04009

Hospital Torrecardenas, Almería

08029

Hospital Del Sagrado Corazon, Barcelona

08035

Hospital General Universitari Vall D�Hebron, Barcelona

09005

Hospital General Yag�, Burgos

510 29

Fritsla Vardcentral, Fritsla

SE-411 17

Migranklinik-Goeteborg, Gothenburg

301 85

Lanssjukhuset Halmstad, Halmstad

251 87

Neurologsektionen, Lasarettet, Helsingborg

263 26

Sjocrona Vardcentral, Höganäs

Unknown

Huddinge Universitetssjukhus, Huddinge

Ahepa University Hospital

Foretagshalsovarden Linden

Huslakargruppen

Limhamns Lakargrupp, Tarnan

Medicinskt Centrum

Sentralsjukehuset I Hedmark

Sint Anna Ziekenhuis

Vardcentralen

164 40

Kistahalsan Ab, Kista

221 21

Lund Lakarmottagningen, Lund

211 36

Lakargruppen Gustaf Adolf, Malmo

195 30

Previa Ab Sigtunahalsan, Märsta

613 30

Oxelohalsan, Oxelösund

105 34

Bankhalsan, Stockholm

113 22

Lakarhuset Odenplan, Stockholm

SE-112 81

St Gorans Sjukhus, Stockholm

135 21

Tyresohalsan Huslakare Ab (Ds For Oc), Tyreso

Tyresohalsan Huslakare Ab, Tyreso

SE-352 34

Kronobergskliniken, Vaxjo

721 89

Centrallasarettet, Västerås

593 81

Vasterviks Sjukhus, Västervik

271 39

Novakliniken, Ystad

01330

Cukurova University Medical Faculty, Adana

All Listed Sponsors
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INDUSTRY

NCT01859481 - Eletriptan Provides Consistent Migraine Relief: Results Of A Within-Patient Multiple-Dose Study | Biotech Hunter | Biotech Hunter