Back to resultsEfficacy, Safety, and Tolerability of Oral Eletriptan for Treatment of Acute Migraine
Primary Purpose
Migraine With or Without Aura
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Placebo
Eletriptan 20 mg
Eletriptan 40 mg
Eletriptan 80 mg
Sponsored by
About this trial
This is an interventional treatment trial for Migraine With or Without Aura
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Arm Label
Placebo
Eletriptan 20 mg
Eletriptan 40 mg
Eletriptan 80 mg
Arm Description
Outcomes
Primary Outcome Measures
Headache responder rate at two hours after the first dose for the first attack.
A headache response was defined as a subject having improvement in headache severity from grade 2 or 3 at baseline to 0 or 1 at two hours post-dose.
Secondary Outcome Measures
Pain free responder rate at two hours after the first dose for the first attack.
Pain free response was defined as improvement from grade 2 or 3 at baseline to grade 0 at two hours post-dose.
Full Information
NCT ID
NCT01978496
First Posted
October 31, 2013
Last Updated
January 26, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01978496
Brief Title
Efficacy, Safety, and Tolerability of Oral Eletriptan for Treatment of Acute Migraine
Official Title
A Multicenter Double-blind, Randomized Placebo Controlled, Parallel Group, Study of the Efficacy and Safety of Oral Eletriptan in Subjects With Acute Migraine
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
July 1996 (undefined)
Primary Completion Date
December 1997 (Actual)
Study Completion Date
December 1997 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine With or Without Aura
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1334 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Eletriptan 20 mg
Arm Type
Experimental
Arm Title
Eletriptan 40 mg
Arm Type
Experimental
Arm Title
Eletriptan 80 mg
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
matching placebo
Intervention Type
Drug
Intervention Name(s)
Eletriptan 20 mg
Intervention Description
20mg oral
Intervention Type
Drug
Intervention Name(s)
Eletriptan 40 mg
Intervention Description
40mg oral
Intervention Type
Drug
Intervention Name(s)
Eletriptan 80 mg
Intervention Description
80mg oral
Primary Outcome Measure Information:
Title
Headache responder rate at two hours after the first dose for the first attack.
Description
A headache response was defined as a subject having improvement in headache severity from grade 2 or 3 at baseline to 0 or 1 at two hours post-dose.
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Pain free responder rate at two hours after the first dose for the first attack.
Description
Pain free response was defined as improvement from grade 2 or 3 at baseline to grade 0 at two hours post-dose.
Time Frame
2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
78 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A160-102&StudyName=Efficacy%2C%20Safety%2C%20and%20Tolerability%20of%20Oral%20Eletriptan%20for%0ATreatment%20of%20Acute%20Migraine
Description
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Learn more about this trial
Efficacy, Safety, and Tolerability of Oral Eletriptan for Treatment of Acute Migraine
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