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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
446
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.
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.
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
Time frame: 18 weeks
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.
Time frame: 18 weeks
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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.
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
...and 33 more locations