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

Condition(s) targeted: Migraine With or Without Aura

Intervention: Placebo (Drug); Eletriptan 40 mg (Drug); Eletriptan 80 mg (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

To determine the tolerability and efficacy of eletriptan in patients who had discontinued oral sumatriptan due to lack of efficacy or intolerable adverse events (AEs) during previous clinical treatment (not a controlled trial).

Official title: A Multicenter, Double - Blind, Randomized, Placebo - Controlled Parallel Group Study of the Efficacy and Safety of Oral Eletriptan (40 and 80mg) Given for the Treatment of Acute Migraine in Subjects Discontinued From Oral Sumatriptan

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: The primary efficacy endpoint was 2-h headache response after taking the first dose of study medication for the first attack

Secondary outcome: Sustained response was defined as achieving a headache response within 2 h post dose, with no recurrence or rescue medication needed

Minimum age: 18 Years. Maximum age: 68 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male and female subjects age ≥ 18 years who met the International Headache Society

(IHS) diagnostic criteria for migraine, with or without aura, and could reasonably expect to suffer at least one acute attack of migraine every 6 weeks.

- Subjects required to have discontinued therapy with oral sumatriptan at least 2

weeks, but not longer than 2 years, prior to the screening visit.

- Female subjects required to be adequately protected against pregnancy.

Exclusion Criteria:

- pregnancy or breastfeeding, known coronary artery disease, significant arrhythmias,

heart failure, significant ECG abnormalities, and uncontrolled hypertension.

- Any significant systemic, organ, neurological, endocrine, metabolic, and

psychological disorders reported by the patient or discovered during the physical examination

- Subjects considered to have atypical migraine such as frequent attacks, prolonged

aura or any migraine that was considered atypical.

- Subjects who, during the course of the trial, required treatment with sumatriptan or

any other 5-HT1B/1D agonist in addition to study medication.

Arhus Kommunehospital, Arhus C 8000, Denmark

Centralsygehuset I Esbjerg, Esbjerg 6700, Denmark

Kas Glostrup, Glostrup 2600, Denmark

Hilleroed Sygehus, Hilleroed 3400, Denmark

Knud Kjaersgaard Pedersen, Hjorring 9800, Denmark

Bispebjerg Hospital, København 2400, Denmark

Neubauer, Ole (Private Practice), Nykoebing F 4800, Denmark

Korsgaard, Anne G. (Private Practice), Odense C 5000, Denmark

Haukiputaan Laakarikeskus, Haukipudas 90830, Finland

Helsinki University Central Hospital, Helsinki 00290, Finland

Hyvinkaa District Hospital, Hyvinkaa 05850, Finland

Torikeskuksen Laakariasema, Jyvaskyla 40100, Finland

Mikkelin Paansarkypoliklinikka (Mikkeli Headache), Mikkeli 50100, Finland

Porin Laakarikeskus, Pori 28100, Finland

Turku Headache Centre, Turku 20110, Finland

Bosch Medicentrum (Locatie Willem Alexander Ziekenhuis), 's-hertogenbosch 5223GV, Netherlands

Sint Lucas Andreas Ziekenhuis (Location: St.Lucas), Amsterdam 1061 AE, Netherlands

Nijmeegs Interkonfessioneel Ziekenhuis Canisius-Wilhelmina, Unknown, Netherlands

Sint Anna Ziekenhuis, Unknown, Netherlands

Sentralsykehuset I Akershus, Nordbyhagen 1474, Norway

Private Practice, Oyvind Rosjo, Oslo 0166, Norway

Volvat Medisinske Senter, Oslo 0303, Norway

Strandquist, Dr. Stein Bror, Tonsberg 3111, Norway

Fylkessjukehuset I Molde, Unknown, Norway

Regionsykehuset I Trondheim, Unknown, Norway

Sentralsjukehuset I Hedmark, Unknown, Norway

Migranklinik-Goeteborg, Goeteborg SE-411 17, Sweden

Neuro Kliniken, Helsingborg, Helsingborg 25221, Sweden

Neurologsektionen, Lasarettet, Helsingborg 251 87, Sweden

Medicin Kliniken, Sjukhuset, Kristinehamn 681 80, Sweden

Medicin Kliniken, Universitetssjukhuset, Lund 22185, Sweden

St Gorans Sjukhus, Stockholm SE-112 81, Sweden

Danderydssjukhus, Unknown, Sweden

Foretagshalsovarden Linden, Unknown 392 31, Sweden

Huslakargruppen, Unknown, Sweden

Lakarhuset, Unknown 162 68, Sweden

Lakarhuset Hermelinen, Unknown 971 06, Sweden

Limhamns Lakargrupp, Tarnan, Unknown 216 16, Sweden

Lundsbysjukhus, Unknown, Sweden

Medicinskt Centrum, Unknown 600 02, Sweden

Primarvarden, Unknown 612 25, Sweden

Vardcentralen, Unknown 660 60, Sweden

Kronobergskliniken, Vaexjoe SE-352 34, Sweden

To obtain contact information for a study center near you, click here.

Starting date: January 1999
Last updated: November 20, 2013