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Trial record 11 of 178 for:    Migraine AND migraine with or without aura

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

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ClinicalTrials.gov Identifier: NCT01989936
Recruitment Status : Completed
First Posted : November 21, 2013
Last Update Posted : November 21, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

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).

Condition or disease Intervention/treatment Phase
Migraine With or Without Aura Drug: Placebo Drug: Eletriptan 40 mg Drug: Eletriptan 80 mg Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 446 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : January 1999
Actual Primary Completion Date : September 2000
Actual Study Completion Date : September 2000

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine

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.




Primary Outcome Measures :
  1. The primary efficacy endpoint was 2-h headache response after taking the first dose of study medication for the first attack [ Time Frame: 18 weeks ]
    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


Secondary Outcome Measures :
  1. Sustained response was defined as achieving a headache response within 2 h post dose, with no recurrence or rescue medication needed [ Time Frame: 18 weeks ]
    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.



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Ages Eligible for Study:   18 Years to 68 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01989936


Locations
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Denmark
Arhus Kommunehospital
Arhus C, Denmark, 8000
Centralsygehuset I Esbjerg
Esbjerg, Denmark, 6700
Kas Glostrup
Glostrup, Denmark, 2600
Hilleroed Sygehus
Hilleroed, Denmark, 3400
Knud Kjaersgaard Pedersen
Hjorring, Denmark, 9800
Bispebjerg Hospital
København, Denmark, 2400
Neubauer, Ole (Private Practice)
Nykoebing F, Denmark, 4800
Korsgaard, Anne G. (Private Practice)
Odense C, Denmark, 5000
Finland
Haukiputaan Laakarikeskus
Haukipudas, Finland, 90830
Helsinki University Central Hospital
Helsinki, Finland, 00290
Hyvinkaa District Hospital
Hyvinkaa, Finland, 05850
Torikeskuksen Laakariasema
Jyvaskyla, Finland, 40100
Mikkelin Paansarkypoliklinikka (Mikkeli Headache)
Mikkeli, Finland, 50100
Porin Laakarikeskus
Pori, Finland, 28100
Turku Headache Centre
Turku, Finland, 20110
Netherlands
Bosch Medicentrum (Locatie Willem Alexander Ziekenhuis)
's-hertogenbosch, Netherlands, 5223GV
Sint Lucas Andreas Ziekenhuis (Location: St.Lucas)
Amsterdam, Netherlands, 1061 AE
Norway
Sentralsykehuset I Akershus
Nordbyhagen, Norway, 1474
Private Practice, Oyvind Rosjo
Oslo, Norway, 0166
Volvat Medisinske Senter
Oslo, Norway, 0303
Strandquist, Dr. Stein Bror
Tonsberg, Norway, 3111
Sweden
Migranklinik-Goeteborg
Goeteborg, Sweden, SE-411 17
Neurologsektionen, Lasarettet
Helsingborg, Sweden, 251 87
Neuro Kliniken, Helsingborg
Helsingborg, Sweden, 25221
Medicin Kliniken, Sjukhuset
Kristinehamn, Sweden, 681 80
Medicin Kliniken, Universitetssjukhuset
Lund, Sweden, 22185
St Gorans Sjukhus
Stockholm, Sweden, SE-112 81
Kronobergskliniken
Vaexjoe, Sweden, SE-352 34
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01989936     History of Changes
Other Study ID Numbers: A1601006
First Posted: November 21, 2013    Key Record Dates
Last Update Posted: November 21, 2013
Last Verified: November 2013

Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Sumatriptan
Eletriptan
Vasoconstrictor Agents
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs