Eletriptan Provides Consistent Migraine Relief: Results Of A Within-Patient Multiple-Dose Study
NCT01859481
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- Male and Female subjects in good general health, aged 18 to 65 years.
- Subjects should meet IHS diagnostic criteria for migraine with or without aura.
- Based on past history, subjects should expect to suffer at least one acute attack of migraine with or without aura, each 6 weeks
- Known coronary-artery disease, clinically significant arrhythmia, heart failure, or
uncontrolled hypertension.
- Pregnant or lactating women.
- Clinically significant electrocardiogram abnormalities at screening.
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Descriptive Information | ||||
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Brief Title ICMJE | Eletriptan Provides Consistent Migraine Relief: Results Of A Within-Patient Multiple-Dose Study | |||
Official Title ICMJE | A Multicentre, Dose Optimisation Study to Assess the Consistency of Efficacy of Eletriptan for the Treatment of Migraine (With and Without Aura) | |||
Brief Summary | Evaluation of headache response at 2 hours for active treated attacks for increasing dose. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment | |||
Condition ICMJE |
| |||
Intervention ICMJE |
| |||
Study Arms ICMJE |
| |||
Publications * | Almas M, Tepper SJ, Landy S, Schweizer E, Ramos E. Consistency of eletriptan in treating migraine: Results of a randomized, within-patient multiple-dose study. Cephalalgia. 2014 Feb;34(2):126-35. doi: 10.1177/0333102413500726. Epub 2013 Aug 14. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 971 | |||
Original Actual Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | March 2002 | |||
Actual Primary Completion Date | March 2002 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Belgium, Czech Republic, Denmark, France, Germany, Greece, Hungary, Italy, Netherlands, Norway, Portugal, Spain, Sweden, Turkey | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01859481 | |||
Other Study ID Numbers ICMJE | A1601015 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | May 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |