Eletriptan for the Treatment of Migraine in Patients With Previous Poor Response or Tolerance to Oral Sumatriptan
NCT ID: NCT01989936
Last Updated: 2021-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
446 participants
INTERVENTIONAL
1999-01-31
2000-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy, Safety, and Tolerability of Oral Eletriptan for Treatment of Acute Migraine
NCT01978496
Eletriptan vs Sumatriptan: A Double-blind, Placebo-controlled, Multiple Migraine Attack Study
NCT01986088
Comparative Study of Oral Eletriptan (40mg and 80mg), Oral Sumatriptan (25mg and 50mg) and Placebo
NCT01986270
Eletriptan Provides Consistent Migraine Relief: Results Of A Within-Patient Multiple-Dose Study
NCT01859481
A Trial to Study of the Effects of Eletriptan 40mg on Mild vs Moderate to Severe Pain Intensity of Migraine
NCT00174395
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo
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.
Eletriptan 40 mg
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.
Eletriptan 80 mg
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
68 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Arhus Kommunehospital
Arhus C, , Denmark
Bispebjerg Hospital
Copenhagen, , Denmark
Centralsygehuset I Esbjerg
Esbjerg, , Denmark
Kas Glostrup
Glostrup Municipality, , Denmark
Hilleroed Sygehus
Hilleroed, , Denmark
Knud Kjaersgaard Pedersen
Hjørring, , Denmark
Neubauer, Ole (Private Practice)
Nykoebing F, , Denmark
Korsgaard, Anne G. (Private Practice)
Odense C, , Denmark
Haukiputaan Laakarikeskus
Haukipudas, , Finland
Helsinki University Central Hospital
Helsinki, , Finland
Hyvinkaa District Hospital
Hyvinkää, , Finland
Torikeskuksen Laakariasema
Jyväskylä, , Finland
Mikkelin Paansarkypoliklinikka (Mikkeli Headache)
Mikkeli, , Finland
Porin Laakarikeskus
Pori, , Finland
Turku Headache Centre
Turku, , Finland
Bosch Medicentrum (Locatie Willem Alexander Ziekenhuis)
's-Hertogenbosch, , Netherlands
Sint Lucas Andreas Ziekenhuis (Location: St.Lucas)
Amsterdam, , Netherlands
Sentralsykehuset I Akershus
Nordbyhagen, , Norway
Private Practice, Oyvind Rosjo
Oslo, , Norway
Volvat Medisinske Senter
Oslo, , Norway
Strandquist, Dr. Stein Bror
Tønsberg, , Norway
Migranklinik-Goeteborg
Gothenburg, , Sweden
Neurologsektionen, Lasarettet
Helsingborg, , Sweden
Neuro Kliniken, Helsingborg
Helsingborg, , Sweden
Medicin Kliniken, Sjukhuset
Kristinehamn, , Sweden
Medicin Kliniken, Universitetssjukhuset
Lund, , Sweden
St Gorans Sjukhus
Stockholm, , Sweden
Kronobergskliniken
Vaxjo, , Sweden
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
, ,
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
To obtain contact information for a study center near you, click here.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
A1601006
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.