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 |
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Recruitment Status :
Completed
First Posted : November 21, 2013
Last Update Posted : November 21, 2013
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Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
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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 |
| 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
Genetics Home Reference related topics:
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 :
- 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 :
- 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
| 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
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
| 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 |