Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Eletriptan 40 mg | Experimental |
| |
| Eletriptan 80 mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arhus Kommunehospital | Arhus C | 8000 | Denmark | |||
| Bispebjerg Hospital |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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 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. |
|
| Copenhagen |
| 2400 |
| Denmark |
| Centralsygehuset I Esbjerg | Esbjerg | 6700 | Denmark |
| Kas Glostrup | Glostrup Municipality | 2600 | Denmark |
| Hilleroed Sygehus | Hilleroed | 3400 | Denmark |
| Knud Kjaersgaard Pedersen | Hjørring | 9800 | Denmark |
| Neubauer, Ole (Private Practice) | Nykoebing F | 4800 | Denmark |
| Korsgaard, Anne G. (Private Practice) | Odense C | 5000 | Denmark |
| Haukiputaan Laakarikeskus | Haukipudas | 90830 | Finland |
| Helsinki University Central Hospital | Helsinki | 00290 | Finland |
| Hyvinkaa District Hospital | Hyvinkää | 05850 | Finland |
| Torikeskuksen Laakariasema | Jyväskylä | 40100 | Finland |
| Mikkelin Paansarkypoliklinikka (Mikkeli Headache) | Mikkeli | 50100 | Finland |
| Porin Laakarikeskus | Pori | 28100 | Finland |
| Turku Headache Centre | Turku | 20110 | Finland |
| Bosch Medicentrum (Locatie Willem Alexander Ziekenhuis) | 's-Hertogenbosch | 5223GV | Netherlands |
| Sint Lucas Andreas Ziekenhuis (Location: St.Lucas) | Amsterdam | 1061 AE | Netherlands |
| Sentralsykehuset I Akershus | Nordbyhagen | 1474 | Norway |
| Private Practice, Oyvind Rosjo | Oslo | 0166 | Norway |
| Volvat Medisinske Senter | Oslo | 0303 | Norway |
| Strandquist, Dr. Stein Bror | Tønsberg | 3111 | Norway |
| Migranklinik-Goeteborg | Gothenburg | SE-411 17 | Sweden |
| Neurologsektionen, Lasarettet | Helsingborg | 251 87 | Sweden |
| Neuro Kliniken, Helsingborg | Helsingborg | 25221 | Sweden |
| Medicin Kliniken, Sjukhuset | Kristinehamn | 681 80 | Sweden |
| Medicin Kliniken, Universitetssjukhuset | Lund | 22185 | Sweden |
| St Gorans Sjukhus | Stockholm | SE-112 81 | Sweden |
| Kronobergskliniken | Vaxjo | SE-352 34 | 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 |
| ID | Term |
|---|---|
| C115647 | eletriptan |
Not provided
Not provided
Not provided