Eletriptan for the Treatment of Migraine in Patients With Previous Poor Response or Tolerance to Oral Sumatriptan

PHASE3CompletedINTERVENTIONAL
Enrollment

446

Participants

Timeline

Start Date

January 31, 1999

Primary Completion Date

September 30, 2000

Study Completion Date

September 30, 2000

Conditions
Migraine With or Without Aura
Interventions
DRUG

Placebo

Subjects were randomized to one of the 3 treatment groups (eletriptan 40 mg, eletriptan 80 mg, or placebo) in a 2:2:1 ratio and were given sufficient medication to treat 3 migraine attacks (including a second dose for each attack for recurrence) within 18 weeks of the initial visit. Subjects were instructed to treat a moderate to severe migraine within 6 hours of the onset of pain provided the headache was not decreasing in severity, the aura phase had ended and they had taken no analgesic or antiemetic within 6 hours. Efficacy data was collected in a diary. Subjects were allowed to take rescue medication if they had no response to the study medication within 4 hours of onset.

DRUG

Eletriptan 40 mg

Subjects were randomized to one of the 3 treatment groups (eletriptan 40 mg, eletriptan 80 mg, or placebo) in a 2:2:1 ratio and were given sufficient medication to treat 3 migraine attacks (including a second dose for each attack for recurrence) within 18 weeks of the initial visit. Subjects were instructed to treat a moderate to severe migraine within 6 hours of the onset of pain provided the headache was not decreasing in severity, the aura phase had ended and they had taken no analgesic or antiemetic within 6 hours. Efficacy data was collected in a diary. Subjects were allowed to take rescue medication if they had no response to the study medication within 4 hours of onset.

DRUG

Eletriptan 80 mg

Subjects were randomized to one of the 3 treatment groups (eletriptan 40 mg, eletriptan 80 mg, or placebo) in a 2:2:1 ratio and were given sufficient medication to treat 3 migraine attacks (including a second dose for each attack for recurrence) within 18 weeks of the initial visit. Subjects were instructed to treat a moderate to severe migraine within 6 hours of the onset of pain provided the headache was not decreasing in severity, the aura phase had ended and they had taken no analgesic or antiemetic within 6 hours. Efficacy data was collected in a diary. Subjects were allowed to take rescue medication if they had no response to the study medication within 4 hours of onset.

Trial Locations (43)

1474

Sentralsykehuset I Akershus, Nordbyhagen

2400

Bispebjerg Hospital, Copenhagen

2600

Kas Glostrup, Glostrup Municipality

3111

Strandquist, Dr. Stein Bror, Tønsberg

3400

Hilleroed Sygehus, Hilleroed

4800

Neubauer, Ole (Private Practice), Nykoebing F

5000

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

6700

Centralsygehuset I Esbjerg, Esbjerg

8000

Arhus Kommunehospital, Arhus C

9800

Knud Kjaersgaard Pedersen, Hjørring

20110

Turku Headache Centre, Turku

22185

Medicin Kliniken, Universitetssjukhuset, Lund

25221

Neuro Kliniken, Helsingborg, Helsingborg

28100

Porin Laakarikeskus, Pori

40100

Torikeskuksen Laakariasema, Jyväskylä

50100

Mikkelin Paansarkypoliklinikka (Mikkeli Headache), Mikkeli

90830

Haukiputaan Laakarikeskus, Haukipudas

00290

Helsinki University Central Hospital, Helsinki

05850

Hyvinkaa District Hospital, Hyvinkää

5223GV

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

1061 AE

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

0166

Private Practice, Oyvind Rosjo, Oslo

0303

Volvat Medisinske Senter, Oslo

SE-411 17

Migranklinik-Goeteborg, Gothenburg

251 87

Neurologsektionen, Lasarettet, Helsingborg

681 80

Medicin Kliniken, Sjukhuset, Kristinehamn

SE-112 81

St Gorans Sjukhus, Stockholm

SE-352 34

Kronobergskliniken, Vaxjo

Unknown

Danderydssjukhus

Foretagshalsovarden Linden

Fylkessjukehuset I Molde

Huslakargruppen

Lakarhuset Hermelinen

Lakarhuset

Limhamns Lakargrupp, Tarnan

Lundsbysjukhus

Medicinskt Centrum

Nijmeegs Interkonfessioneel Ziekenhuis Canisius-Wilhelmina

Primarvarden

Regionsykehuset I Trondheim

Sentralsjukehuset I Hedmark

Sint Anna Ziekenhuis

Vardcentralen

All Listed Sponsors
lead

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

INDUSTRY

NCT01989936 - Eletriptan for the Treatment of Migraine in Patients With Previous Poor Response or Tolerance to Oral Sumatriptan | Biotech Hunter | Biotech Hunter