Clinical trial NCT01989936: Eletriptan for the Treatment of Migraine in Patients With Previous Poor Response or Tolerance to Oral Sumatriptan
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine With or Without Aura
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-11-21
Enrollment: 446
Sex: ALL
Minimum age (years): 18
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility 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.

Primary outcomes:
measure: The primary efficacy endpoint was 2-h headache response after taking the first dose of study medication for the first attack
timeFrame: 18 weeks
Secondary outcomes:
measure: Sustained response was defined as achieving a headache response within 2 h post dose, with no recurrence or rescue medication needed
timeFrame: 18 weeks
Other outcomes:
Locations:
city: Arhus C
country: Denmark
facility: Arhus Kommunehospital
city: Esbjerg
country: Denmark
facility: Centralsygehuset I Esbjerg
city: Glostrup
country: Denmark
facility: Kas Glostrup
city: Hilleroed
country: Denmark
facility: Hilleroed Sygehus
city: Hjorring
country: Denmark
facility: Knud Kjaersgaard Pedersen
city: København
country: Denmark
facility: Bispebjerg Hospital
city: Nykoebing F
country: Denmark
facility: Neubauer, Ole (Private Practice)
city: Odense C
country: Denmark
facility: Korsgaard, Anne G. (Private Practice)
city: Haukipudas
country: Finland
facility: Haukiputaan Laakarikeskus
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
city: Hyvinkaa
country: Finland
facility: Hyvinkaa District Hospital
city: Jyvaskyla
country: Finland
facility: Torikeskuksen Laakariasema
city: Mikkeli
country: Finland
facility: Mikkelin Paansarkypoliklinikka (Mikkeli Headache)
city: Pori
country: Finland
facility: Porin Laakarikeskus
city: Turku
country: Finland
facility: Turku Headache Centre
city: 's-hertogenbosch
country: Netherlands
facility: Bosch Medicentrum (Locatie Willem Alexander Ziekenhuis)
city: Amsterdam
country: Netherlands
facility: Sint Lucas Andreas Ziekenhuis (Location: St.Lucas)
city: Nordbyhagen
country: Norway
facility: Sentralsykehuset I Akershus
city: Oslo
country: Norway
facility: Private Practice, Oyvind Rosjo
city: Oslo
country: Norway
facility: Volvat Medisinske Senter
city: Tonsberg
country: Norway
facility: Strandquist, Dr. Stein Bror
city: Goeteborg
country: Sweden
facility: Migranklinik-Goeteborg
city: Helsingborg
country: Sweden
facility: Neurologsektionen, Lasarettet
city: Helsingborg
country: Sweden
facility: Neuro Kliniken, Helsingborg
city: Kristinehamn
country: Sweden
facility: Medicin Kliniken, Sjukhuset
city: Lund
country: Sweden
facility: Medicin Kliniken, Universitetssjukhuset
city: Stockholm
country: Sweden
facility: St Gorans Sjukhus
city: Vaexjoe
country: Sweden
facility: Kronobergskliniken
facility: Danderydssjukhus
facility: Foretagshalsovarden Linden
facility: Fylkessjukehuset I Molde
facility: Huslakargruppen
facility: Lakarhuset Hermelinen
facility: Lakarhuset
facility: Limhamns Lakargrupp, Tarnan
facility: Lundsbysjukhus
facility: Medicinskt Centrum
facility: Nijmeegs Interkonfessioneel Ziekenhuis Canisius-Wilhelmina
facility: Primarvarden
facility: Regionsykehuset I Trondheim
facility: Sentralsjukehuset I Hedmark
facility: Sint Anna Ziekenhuis
facility: Vardcentralen
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: