Efficacy, Safety, and Tolerability of Oral Eletriptan for Treatment of Acute Migraine
NCT01978496
ABOUT THIS STUDY
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- History of at least one typical attack of migraine with or without aura every 6 weeks, as defined by the International Headache Society (IHS) criteria.
- Capable of taking study medication as outpatients and recording its effects.
- Pregnant or breast-feeding women
- Migraine subjects who also suffered from concomitant frequent (non-migraine) headache,
defined as more than six headaches per month on average
- Migraine attacks that were thought to be atypical and had consistently failed to
respond to medical therapy.
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Descriptive Information | ||||
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Brief Title ICMJE | Efficacy, Safety, and Tolerability of Oral Eletriptan for Treatment of Acute Migraine | |||
Official Title ICMJE | A Multicenter Double-blind, Randomized Placebo Controlled, Parallel Group, Study of the Efficacy and Safety of Oral Eletriptan in Subjects With Acute Migraine | |||
Brief Summary | To confirm the efficacy of three dose levels of oral eletriptan relative to placebo in relieving symptoms of acute migraine and to further explore the dose response relationship of eletriptan. | |||
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 | Migraine With or Without Aura | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* 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 | 1334 | |||
Original Actual Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | December 1997 | |||
Actual Primary Completion Date | December 1997 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 78 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Not Provided | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01978496 | |||
Other Study ID Numbers ICMJE | A160-102 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. ) | |||
Study Sponsor ICMJE | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | January 2021 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |