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

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

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).

Study Overview

• Status: Completed
• Conditions: Migraine With or Without Aura
• Intervention / Treatment: Drug: Placebo; Drug: Eletriptan 40 mg; Drug: Eletriptan 80 mg

• Study Type: Interventional
• Enrollment (Actual): 446
• Phase: Phase 3

Contacts and Locations

Study Locations

• • • Foretagshalsovarden Linden
  • • Huslakargruppen
  • • Limhamns Lakargrupp, Tarnan
  • • Medicinskt Centrum
  • • Sentralsjukehuset I Hedmark
  • • Sint Anna Ziekenhuis
  • • Vardcentralen
  • • Danderydssjukhus
  • • Fylkessjukehuset I Molde
  • • Lakarhuset Hermelinen
  • • Läkarhuset
  • • Lundsbysjukhus
  • • Nijmeegs Interkonfessioneel Ziekenhuis Canisius-Wilhelmina
  • • Primarvarden
  • • Regionsykehuset I Trondheim
• Denmark
  • Arhus C, Denmark, 8000
    • Århus Kommunehospital
  • Esbjerg, Denmark, 6700
    • Centralsygehuset I Esbjerg
  • Glostrup, Denmark, 2600
    • KAS Glostrup
  • Hilleroed, Denmark, 3400
    • Hilleroed Sygehus
  • Hjorring, Denmark, 9800
    • Knud Kjaersgaard Pedersen
  • København, Denmark, 2400
    • Bispebjerg Hospital
  • Nykoebing F, Denmark, 4800
    • Neubauer, Ole (Private Practice)
  • Odense C, Denmark, 5000
    • Korsgaard, Anne G. (Private Practice)
• Finland
  • Haukipudas, Finland, 90830
    • Haukiputaan Laakarikeskus
  • Helsinki, Finland, 00290
    • Helsinki University Central Hospital
  • Hyvinkaa, Finland, 05850
    • Hyvinkää District Hospital
  • Jyvaskyla, Finland, 40100
    • Torikeskuksen Laakariasema
  • Mikkeli, Finland, 50100
    • Mikkelin Paansarkypoliklinikka (Mikkeli Headache)
  • Pori, Finland, 28100
    • Porin Laakarikeskus
  • Turku, Finland, 20110
    • Turku Headache Centre
• Netherlands
  • 's-hertogenbosch, Netherlands, 5223GV
    • Bosch Medicentrum (Locatie Willem Alexander Ziekenhuis)
  • Amsterdam, Netherlands, 1061 AE
    • Sint Lucas Andreas Ziekenhuis (Location: St.Lucas)
• Norway
  • Nordbyhagen, Norway, 1474
    • Sentralsykehuset I Akershus
  • Oslo, Norway, 0303
    • Volvat Medisinske Senter
  • Oslo, Norway, 0166
    • Private Practice, Oyvind Rosjo
  • Tonsberg, Norway, 3111
    • Strandquist, Dr. Stein Bror
• Sweden
  • Goeteborg, Sweden, SE-411 17
    • Migranklinik-Goeteborg
  • Helsingborg, Sweden, 251 87
    • Neurologsektionen, Lasarettet
  • Helsingborg, Sweden, 25221
    • Neuro Kliniken, Helsingborg
  • Kristinehamn, Sweden, 681 80
    • Medicin Kliniken, Sjukhuset
  • Lund, Sweden, 22185
    • Medicin Kliniken, Universitetssjukhuset
  • Stockholm, Sweden, SE-112 81
    • St Gorans Sjukhus
  • Vaexjoe, Sweden, SE-352 34
    • Kronobergskliniken

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	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.
Experimental: Eletriptan 40 mg	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.
Experimental: Eletriptan 80 mg	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary efficacy endpoint was 2-h headache response after taking the first dose of study medication for the first attack	Subjects recorded the intensity of each migraine headache in the diary based on a 4-point scale: 0, pain absent; 1, mild pain; 2, moderate pain; 3, severe pain. A response was considered a change from severe or moderate pain to mild or absent at various time points after dosing with study medication	18 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sustained response was defined as achieving a headache response within 2 h post dose, with no recurrence or rescue medication needed	Recurrence was defined as a return of headache to moderate or severe intensity within 2-24 h if the subject had an initial response within 2 h of taking the study medication.	18 weeks

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: January 1, 1999
• Primary Completion (Actual): September 1, 2000
• Study Completion (Actual): September 1, 2000

Study Registration Dates

• First Submitted: October 30, 2013
• First Submitted That Met QC Criteria: November 20, 2013
• First Posted (Estimate): November 21, 2013

Study Record Updates

• Last Update Posted (Actual): January 27, 2021
• Last Update Submitted That Met QC Criteria: January 26, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Serotonin Agents; Serotonin Receptor Agonists; Eletriptan
• Other Study ID Numbers: A1601006