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

NCT01989936 | Completed Phase 3 DMC

• 1 other identifier: A1601006
• Study Type: interventional
• Target: 446
• Locations: 5 countries
• Sites: 28

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).

Conditions

Migraine With or Without Aura

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  18 weeks

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Eletriptan 40 mg

EXPERIMENTAL

Drug: Eletriptan 40 mg

Eletriptan 80 mg

EXPERIMENTAL

Drug: Eletriptan 80 mg

Interventions

Placebo DRUG

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.

Placebo

Eletriptan 40 mg DRUG

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.

Eletriptan 40 mg

Eletriptan 80 mg DRUG

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.

Eletriptan 80 mg

Eligibility Criteria

• Age: 18 Years - 68 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (43)

Arhus Kommunehospital

Arhus C, 8000, Denmark

Location

Bispebjerg Hospital

Copenhagen, 2400, Denmark

Location

Centralsygehuset I Esbjerg

Esbjerg, 6700, Denmark

Location

Kas Glostrup

Glostrup Municipality, 2600, Denmark

Location

Hilleroed Sygehus

Hilleroed, 3400, Denmark

Location

Knud Kjaersgaard Pedersen

Hjørring, 9800, Denmark

Location

Neubauer, Ole (Private Practice)

Nykoebing F, 4800, Denmark

Location

Korsgaard, Anne G. (Private Practice)

Odense C, 5000, Denmark

Location

Haukiputaan Laakarikeskus

Haukipudas, 90830, Finland

Location

Helsinki University Central Hospital

Helsinki, 00290, Finland

Location

Hyvinkaa District Hospital

Hyvinkää, 05850, Finland

Location

Torikeskuksen Laakariasema

Jyväskylä, 40100, Finland

Location

Mikkelin Paansarkypoliklinikka (Mikkeli Headache)

Mikkeli, 50100, Finland

Location

Porin Laakarikeskus

Pori, 28100, Finland

Location

Turku Headache Centre

Turku, 20110, Finland

Location

Bosch Medicentrum (Locatie Willem Alexander Ziekenhuis)

's-Hertogenbosch, 5223GV, Netherlands

Location

Sint Lucas Andreas Ziekenhuis (Location: St.Lucas)

Amsterdam, 1061 AE, Netherlands

Location

Sentralsykehuset I Akershus

Nordbyhagen, 1474, Norway

Location

Private Practice, Oyvind Rosjo

Oslo, 0166, Norway

Location

Volvat Medisinske Senter

Oslo, 0303, Norway

Location

Strandquist, Dr. Stein Bror

Tønsberg, 3111, Norway

Location

Migranklinik-Goeteborg

Gothenburg, SE-411 17, Sweden

Location

Neurologsektionen, Lasarettet

Helsingborg, 251 87, Sweden

Location

Neuro Kliniken, Helsingborg

Helsingborg, 25221, Sweden

Location

Medicin Kliniken, Sjukhuset

Kristinehamn, 681 80, Sweden

Location

Medicin Kliniken, Universitetssjukhuset

Lund, 22185, Sweden

Location

St Gorans Sjukhus

Stockholm, SE-112 81, Sweden

Location

Kronobergskliniken

Vaxjo, SE-352 34, Sweden

Location

Danderydssjukhus

Location

Foretagshalsovarden Linden

Location

Fylkessjukehuset I Molde

Location

Huslakargruppen

Location

Lakarhuset Hermelinen

Location

Lakarhuset

Location

Limhamns Lakargrupp, Tarnan

Location

Lundsbysjukhus

Location

Medicinskt Centrum

Location

Nijmeegs Interkonfessioneel Ziekenhuis Canisius-Wilhelmina

Location

Primarvarden

Location

Regionsykehuset I Trondheim

Location

Sentralsjukehuset I Hedmark

Location

Sint Anna Ziekenhuis

Location

Vardcentralen

Location

Related Links

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

MeSH Terms

Interventions

eletriptan

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2013
• First Posted: November 21, 2013
• Study Start: January 1, 1999
• Primary Completion: September 1, 2000
• Study Completion: September 1, 2000
• Last Updated: January 27, 2021

Record last verified: 2021-01

Locations

NO (4); FI (7); NL (2); SE (7); DK (8)